Preventing Diabetic Foot Disease in the Intellectually & Developmentally Disabled Population
Below is a copy of Dr. Brown's Masters Thesis in Public Health submitted in 2017 to Mt. Sinai Icahn School of Medicine. Spacing and page numbers will be incorrect.
HappeeFeet Program Plan
A Theoretical Framework Plan for a Program:
“Preventing Diabetic Foot Disease in the Intellectually and Developmentally Disabled (IDD) Population”
Foot Screening & Preventative Foot Care Education
Austin M. Brown
Graduate Program in Public Health, Icahn School of Medicine at Mt. Sinai
Class of 2018 DPM Candidate, New York College of Podiatric Medicine
Anthony R. Iorio, DPM, MPH
New York College of Podiatric Medicine
Gary Rosenberg, PhD
Graduate Program in Public Health, Icahn School of Medicine at Mt. Sinai
For Partial Fulfillment of the Masters in Public Health Degree
Intro: The Intellectually & Developmentally Disabled (IDD) population experiences many health disparities including a higher risk for developing Diabetes Mellitus (DM).
Background: The first signs of DM can manifest in the feet. DM leads to peripheral vascular disease (PVD) and neuropathy, which leads to an ulcer that can become infected and ultimately require leg amputation. Treating diabetic foot disease requires intensive & expensive medical care.
Methods: The HappeeFeet Program Plan has the vision and mission of preventing diabetic foot disease in the IDD population by providing foot screenings and preventative foot care education. Objectives of the program include: 1) improve access to foot health care, 2) make referrals to local health professionals when appropriate, 3) train students and providers about IDD lower extremity needs and care, 4) collect, analyze, and disseminate data on IDD foot health status and needs, 5) advocate for improved health policies and programs for the IDD population.
Results: The activities include: A) develop student training material, B) train students for foot screening, C) perform risk assessment & data collection through foot screening, D) develop a survey assessing perceived foot pain and function, E) assess screening & survey data for prevalence rates in IDD, F) referral of high-risk individuals to local providers.
Discussion: Obstacles to program implementation and evaluation include coordinating program logistics and the current Medicaid environment neglecting preventative podiatry services.
Conclusions: Implementing a program like HappeeFeet may impact healthcare expenditures on diabetes complications ($174B) and IDD-specific care ($400B).
Table of Contents
Components of Culminating Experience Paper (Page Number[s])
- Culminating Experience Title Page (1)
- Abstract (2)
- Table of Contents (3-4)
- Introduction (6-8)
- What is IDD (Intellectual & Developmental Disability)? (6)
- Why is the IDD Population a Concern for Public Health Advocates? (6-8)
- Specific Aims (9)
- Background Information (10-15)
- Chronic Diseases Impact on Public Health (10-11)
- Economic Rationale for Preventative Healthcare (11)
- Diabetes Mellitus (DM) (11)
- Diabetic Foot Ulcers (DFUs) (12)
- Rationale for Preventing Diabetic Foot Ulcers (DFUs) (12-13)
- What is the prevalence of DM in the IDD population? (13-14)
- What podiatry conditions are more prevalent in the IDD population compared to the general population? (14-15)
- Rationale (16-22)
- Risk Factors in the IDD population (16)
- The IDD Population is At-Risk for DFUs due to lack of proper Diabetes Management (17-18)
- Foot-shoe mismatch in IDD population: Another Risk Factor (18)
- Awareness of Foot Problems & Effect on Quality of Life (18-19)
- Impact of DFUs on Quality of Life (19-20)
- Economic Impact of DFUs (20-21)
- Economic Rationale for preventing DFU (21-22)
- Project Design & Methods (23-26)
- Situation Statement (23)
- Program Goals (23)
- Audience and Potential Stakeholders (23-24)
- Program Overview & Description of Vision, Mission, & Objectives (24)
- Program Activities (25-26)
- Timeline for Program Implementation – See conclusion section
- Program Evaluation & Measures of Progress - See conclusion section
- Vision for Data Utilization (26)
- Results: Basis for Program Activities (27-43)
- Develop Student Training Material (28-31)
- Prevention of DFUs (27-29)
- DFU Primary Prevention: identifying and modifying DFU risk factors to avoid DFU occurrence (29-30)
- Develop Student Training Material (28-31)
- DFU Secondary Prevention: avoiding delays in the recognition of DFUs (30-31)
- Train Students for Foot Screening (31-33)
- How to do a 3-minute diabetic foot exam (31-33)
- Perform Risk Assessment & Data Collection Through Foot Screening (34-36)
- Risk Assessment (34-35)
- Risk Factors for Development of Diabetic Foot Ulcer (DFU) (35-36)
- Risk Factors for Limb Loss (36)
- Develop a Survey Assessing Perceived Foot Pain & Function (37-38)
- What is the Bristol Foot Score? (37)
- Why Use the Bristol Foot Score? (37)
- Other Questionnaires for Foot Health (37-38)
- Assess Screening & Survey Data for Prevalence Rates in IDD (38-41)
- Need for more research into IDD foot pathology (38)
- Special Olympics Fit Feet Program – A Model Foot Screening Initiative for IDD (38-39)
- Findings from Special Olympics Data by Jenkins on foot pathology in IDD (39-41)
- Referral of High-Risk Individuals to Local Providers (41-43)
- Podiatry’s Role in Preventing DFUs in the IDD Population (41-43)
- Discussion (44-48)
- List of Potential Obstacles to Program Implementation (44)
- Legislation Addressing Podiatry Coverage for Medicaid: The HELLPP Act (44-46)
- The Need for more primary prevention Research/RCTs for DFUs (47-48)
- Conclusion (49-50)
- Timeline for Program Implementation (49)
- Plan for Program Evaluation (49-50)
- Appendix (51-52)
- Bibliography & References (53-68)
List of Tables & Charts (Page Number)
(7) 1) Population Differences Between People with and without disabilities on health indicators of health care access, health behaviors, health status, and social determinants of health. (Krahn, 2015 – Table 1)
(13) 2) The clinical states leading to limb loss among patients with diabetes and the risk factors that influence the transition between these states (Barshes, 2013 – Fig. 1)
(20) 3) Comparison of the burden of disease, detection, and management of colorectal cancer and diabetes related limb loss (Barshes, 2013 - Table 1)
(21) 4) The estimated annual direct costs of diabetic limb complications in comparison to the annual direct costs of the five most costly cancers in the US. (Barshes, 2013 – Fig 2)
(25) 5) Program Plan Logic Model – Table
(28) 6) Components of diabetic foot care and respective objectives (Barshes, 2013 – Table 2)
(29) 7) Prevention of foot ulceration in persons with diabetes - recommended management based on results of clinical evaluation (Singh, 2005 - Table 4)
(30) 8) Screening methods to identify people with diabetes at increased risk for foot ulceration (Singh, 2005 - Table 1)
(32) 9) What to ask (1 minute) (Miller, 2013 – Table 1)
(33) 10) What to look for (1 minute) (Miller, 2013 – Table 2)
(33) 11) What to teach (1 minute) (Miller, 2013 – Table 3)
(34) 12) Time for a specialist? Mapping out a treatment and follow-up plan (Miller, 2013 – Table 4)
(34) 13) Risk classification based on the comprehensive foot examination (Boulton, 2008 – Table 4)
(36) 14) Rates of diabetic peripheral neuropathy and its complications in the US (Gordis 2003 - Table 1)
(40) 15) Joint Range of Motion (Jenkins, 2014 – Table 2)
(40) 16) Biomechanical conditions (Jenkins, 2011 – Table 3)
(41) 17) Structural conditions in IDD compared internationally (Jenkins 2014 - Table 3)
(42) 18) Overview of the scope of podiatric care for the diabetic limb (Kim, 2012 – Table 1)
(52) 19) The Bristol Foot Score – in Appendix
Overview: The Intellectually & Developmentally Disabled (IDD) population experiences many health disparities including a higher risk for developing Diabetes Mellitus (DM) compared to the general population.
- What is IDD?
- Why is the IDD Population a Concern for Public Health Advocates?
What is IDD (Intellectual & Developmental Disability)?
Intellectual and developmental disability (IDD) is a disability acquired before the age of 18 and is characterized by significant limitations in both intellectual functioning and adaptive behavior as expressed in conceptual, social, and practical adaptive skills. IDD encompasses many formal diagnoses including autism spectrum disorders, mental retardation, Fragile-X syndrome, cerebral palsy, Down syndrome, Prader-Willi syndrome, fetal alcohol syndrome, Klinefelter’s syndrome, and Williams syndrome. Down syndrome, fragile X syndrome, and fetal alcohol syndrome are responsible for one-third of all intellectual disabilities seen in the general population (Batshaw, 2007).
According to the World Health Organization, over a billion people, about 15% of the world’s population, have some form of disability with between 110 million (2.2%) to 190 million (3.8%) of people 15 years and older having significant difficulties in functioning (WHO Media Centre – Disability and Health, 2015; American Association on Intellectual and Developmental Disability; American Psychiatric Association ). Article 25 of the UN Convention on the Rights of Persons with Disabilities reinforces the right of persons with disabilities to attain the highest standard of health care, without discrimination. People with disabilities report seeking more health care than people without disabilities and have greater unmet needs. Health promotion and prevention activities seldom target people with disabilities.
Why is the IDD Population a Concern for Public Health Advocates?
Krahn et al (2015) have led the charge in the public health community in formally recognizing the IDD population as at risk for experiencing many health disparities. Adults with IDD are four times more likely to report their health to be fair or poor than people without IDD (40.3% vs. 9.9%) (Altman, 2008). There is general agreement that health disparities refer to differences in health outcomes at the population level, that these differences are linked to a history of social, economic, or environmental disadvantages, and that these differences are regarded as avoidable (Krahn, 2015). The International Classification of Functioning Disability and Health (ICF) has been adopted internationally and is the most accepted model of disability in public health (Iezzoni, 2008), but its adoption in the U.S. has been slow, potentially because the use of ICF would require coding changes to billing and administrative systems (Krahn, 2015). In 2003, there were at least 67 US federal statutory definitions of disability (Cherry Engineering Support Services, Inc.). Due to the varying methods of defining and surveying, disability prevalence estimates in public health ranges from 12% to 30% (Altman, 2008; Krahn, 2015).
(Table from: Krahn, 2015)
After an in-depth historical and data analysis, Krahn makes the argument to solidify individuals with IDD as a health disparity population: “The available evidence documents that people with disabilities meet all the criteria for a disparity population. They experienced a history of social, economic, and environmental disadvantages in which children and adults with disabilities were institutionalized and marginalized. They experience documented differences in health outcomes at the population level that relate to higher rates of unmet health care needs, unhealthy lifestyle behaviors, mental health and chronic diseases, and social determinants of poor health. Finally, many of these differences are recognized as avoidable and disproportionately affect this population” (Krahn, 2015). It is important to establish the IDD population as a health disparity population since this will generate more awareness, support, and funding for this population. Health expenditures associated with disabilities, including medical care and long-term services, has been estimated at $400 billion annually (Anderson, 2010), with 70% of these costs covered through public programs (Krahn, 2015). To address this issue, the Office of the Surgeon General issued a report that outlined a blue print for action to improve the health of people with IDD (2002; 2005; source: Krahn, 2015). Additionally, disability health is 1 of 42 topic areas in Healthy People 2020 (USDHH, 2010) with 20 objectives that span systems and policies (3 objectives), barriers to health care (4 objectives), environment (5 objectives), and activities and participation (8 objectives) (Krahn, 2015).
The onus behind such objectives is that the IDD population experiences many health disparities in greater proportions compared to the general population. Individuals with IDD are at greater risk of developing diabetes, in part, because of their poor diet, sedentary lifestyle and cognitive and adaptive limitations, which may impede their ability to make healthy choices and access to appropriate preventative care (Shireman, 2010). Furthermore, their ability to manage and monitor a chronic condition such as diabetes is compromised (McElduff, 2002). Adults with disabilities are 2.5 times more likely to report skipping or delaying health care because of cost (Altman, 2008; CDC - MMWR, 2010). Adults with disabilities are significantly less likely to receive preventative care (Diab, 2004; Iezzoni, 2000). Therefore, advocacy for preventative care in the IDD population is needed to address the multitude of health disparities.
Overview: The specific aims of the Culminating Experience paper is to detail the program plan outline and provide the background evidence and rationale for designing a program of this type for the IDD population. The program plan is intended to be a proof of concept pilot model for preventing foot complications in the IDD population.
The purpose of this Culminating Experience Project is to combine the author’s passions of public health prevention, foot and ankle care, and addressing health disparities among the IDD population. Therefore, the specific aims of the paper are to establish the IDD population’s health disparity (specifically diabetes mellitus) as a public health issue that can and should be addressed by a podiatrist as a part of the integrated care team. This will include delineating the prevalence of diabetes in the IDD population and establishing them as a high risk population for the development of foot ulceration. In order to do so, the risk factors for diabetic foot ulcers (DFUs) will be explored with relevant correlation of these risk factors in the IDD population. Once establishing the IDD population as high risk for development of DFUs, advocacy for prevention of DFUs will be stressed. This will include appropriate prevention strategies and interventions for DFUs. The goal for the IDD population is to prevent the first occurrence of a DFU since once one has occurred, it has significant effects on the quality of life and is extremely costly to the healthcare system. A further discussion will explore the podiatrist’s involvement in preventing DFUs in the IDD population, such as proper screening for risk factors and educating patients and care givers about foot health. Finally, policy recommendations for podiatry coverage, specifically Medicaid, will be discussed to address the gap in reimbursement for podiatrists and coverage of foot and ankle care for the IDD population.
Specific Objectives of the Culminating Experience Paper:
- Identify the prevalence of diabetes mellitus in the IDD population and bring awareness to the lack of attention amongst an at-risk and underserved population
- Identify the foot and ankle conditions prevalent among the IDD population
- Stress the value and importance of podiatry care for treating and preventing costly public health concerns related to diabetic foot disease
- Identify early signs and risk factors for diabetic foot changes
- Promote primary prevention strategies to combat diabetic foot disease
- Provide recommendations for addressing the lower extremity public health disparities experienced by the IDD population
Background Overview: DM is a huge public health issue with the first signs and symptoms beginning in the feet. With the IDD pop, there are many health disparities and barriers to receiving preventative foot and ankle care. Without proper education, routine foot care, and maintenance of foot hygiene, individuals with are at high risk for developing diabetic foot ulcers (DFUs), which is a breakdown of the skin and tissue that can become infected, require hospitalization and intensive treatment, and possibly result in partial or full loss of the lower leg. All of these cumulative effects have strong impact on quality of life for DM individuals. Therefore, it is imperative to prevent the development or occurrence of DFUs in at risk populations, in this case, the IDD population. The IDD population has barriers to proper DM care such and knowledge/cognitive function and ability to administer self-care. Health promotion efforts are needed to educate the IDD population and their caregivers about DFU development and risk factors and how to prevent this disabling condition in a vulnerable and at-risk population.
- Establish the public health impact of chronic diseases in the United States, with particular focus on diabetes mellitus and foot ulcers.
- Chronic Diseases Impact on Public Health
- Economic Rationale for Preventative Healthcare
- Diabetes Mellitus (DM)
- Diabetic Foot Ulcers (DFUs)
- Rationale for Preventing Diabetic Foot Ulcers (DFUs)
- Establish the program plan needs assessment for the IDD population
- What is the prevalence of DM in the IDD population?
- What podiatry conditions are more prevalent in the IDD population compared to the general population?
Chronic Diseases Impact on Public Health
Chronic Diseases are a major public health crisis because of their impact on quality of life, morbidity and mortality, and cost to the healthcare system: Almost one out of every two U.S. adults (~107 million people) reported having at least one of six chronic illnesses – cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease, asthma, or arthritis – in 2008 (APHA- Get the Facts). Seven out of ten deaths among Americans each year are from chronic diseases with heart disease, cancer, and stroke accounting for more than 50% of all yearly deaths (CDC, 2012). Obesity, which can lead to heart disease, stroke, type 2 diabetes, and cancer, costs the U.S. $147 billion annually in 2008 dollars (CDC, Overweight and Obesity Facts, 2012). By 2030, medical costs associated with obesity are expected to increase by at least $48 billion annually, with the annual loss in economic productivity totaling $390 billion to $580 billion (Trust for America’s Health (TFAH), 2012).
Chronic Diseases are just as prevalent and worrisome among the IDD population: Individuals with IDD have high rates of overweight and obesity (De, 2008; Lloyd, 2012; Maiano, 2011; Mikulovic, 2011; Stewart, 2009; Foley, 2014). The high rates of overweight and obesity contribute to the high rates of secondary health conditions experienced in the IDD population (Rimmer, 2010). Studies conclude that many adults with IDD are at risk for developing chronic health conditions secondary to their primary impairment (Yamaki, 2005; Rimmer & Yamaki, 2006). Due to the vast array of health disparities experienced by the IDD population, historically, this population has experienced shorter life expectancies and reduced quality of life than the general population (Yang, 2002; Temple, 2014).
Economic Rationale for Preventative Healthcare
The five most costly and preventable chronic conditions cost the U.S. nearly $347 billion (30% of total health spending) in 2010 (Agency for Healthcare Research Quality, Medical Expenditure Panel Survey, 2010). Effective public health interventions and policies that target chronic diseases lead to a healthier population with lower health care spending, less school and workplace absenteeism, increased economic productivity, and an improved quality of life (APHA, 2012). By investing in prevention and treatment of the most common chronic diseases, the U.S. could decrease treatment costs by $218 billion per year and reduce the economic impact of disease by $1.1 trillion annually (Milken Institute, 2007).
Diabetes Mellitus (DM)
Diabetes is a chronic disease in which the body does not produce or properly use insulin. About 90-95% of all diagnosed cases are type 2 diabetes, also known as adult-onset diabetes. The diagnosis of diabetes is associated with serious long-term complications including heart disease, stroke, kidney disease, blindness, and limb amputation. Risk factors for diabetes include older age, family history, obesity, physical inactivity, and race and ethnicity.
According to the Centers for Disease Control and Prevention, 7.8% of the United States population had diabetes in 2007, which comes out to nearly 26 million children and adults with diabetes; in addition, about 79 million people have pre-diabetes (CDC Diabetes factsheet). About 1.9 million new cases of diabetes were diagnosed in 2010 among people ages 20 and older. Nearly 600 million people worldwide are expected to have diabetes by 2035 (International Diabetes Federation, 2013), of which about 50% will develop peripheral neuropathy and 15-25% have been estimated to develop one or more foot ulcers (Singh, 2005,Boulton, 2004). Diabetes is the seventh leading cause of death in the U.S. and in 2007, diabetes contributed to a total of 231,404 deaths. During 2007, diabetes cost the U.S. $174 billion with $116 billion going towards direct medical costs of diabetes and $58 billion in indirect costs (i.e. lost productivity) (APHA, Best Practices for Diabetes Prevention). Diabetes is the leading cause of kidney failure, non-traumatic lower extremity amputations (LEAs), and blindness among 20 to 74 year olds (CDC, Chronic Diseases and Health Promotion, 2012).
Diabetic Foot Ulcers (DFUs)
Systemic manifestations of diabetes often present first in the foot (Lauterbach, 2010). A diabetic foot ulcer is an open wound or sore that generally occurs on the bottom of the foot (APMA). People with diabetes have a 25% chance of developing a foot ulcer in their lifetime (Singh, 2005), and it has been estimated that ~2.5% of the 415 million adults worldwide who have diabetes also have diabetic foot ulcers (Kerr, 2014). Foot ulcers are the most prevalent problem, with a yearly incidence of around 2-4% in developed countries (Boulton, 2005) and likely even higher in developing countries. Ulcer prevalence among persons aged under 44 years was 6.5/1000 diabetics and it rose progressively to 10.3/1000 diabetics in individuals aged over 75 years. Hospitalizations for lower extremity amputations rose from 33,000 in 1980 to 71,000 in 2005 (Driver, 2010).
The most important factors underlying the development of foot ulcers are peripheral sensory neuropathy, foot deformities related to motor neuropathy, minor foot trauma, and peripheral artery disease. Once the skin is ulcerated, it is susceptible to becoming infected, an urgent medical problem. Around a quarter of all diabetes-related hospital admissions within Europe and the USA stem from diabetic foot infections (Boulton, 1999). Only two thirds of foot ulcers will eventually heal (Jeffcoat, 2006; Prompers, 2008), and up to 28% may result in some form of lower extremity amputation (LEA) (Armstrong, 1998). Every year, more than 1 million people with diabetes lose at least a part of their leg as a consequence of the complications of diabetes. This translates into the estimate that every 20 seconds a lower limb is lost to diabetes somewhere in the world (Boulton, 2005).
Rationale for Preventing Diabetic Foot Ulcers (DFUs)
“By far the most effective way to prevent the heavy patient and economic burden [of diabetic foot] is by preventing the foot ulcer.” -Bus & van Netten, 2016.
Bus and van Netten argue that up to 75% of foot ulcers are preventable and call for an urgent shift in priority in diabetic foot care and research. Since as much as 90% of non-traumatic lower extremity amputations are preceded by a diabetic foot ulcer (Pecoraro, 1990), it is imperative to make attempts to prevent the initial occurrence of a DFU. Early recognition of foot problems and effective intervention along the causative pathways may not only improve outcomes by reducing major amputations and increasing quality of life, but also reduce costs related to diabetic foot complications (Driver, 2010). DFUs are analogous to many cancers in that the diagnosis and management of certain identifiable/visible precursor states may halt progression of disease and reduce end-stage complications (Anichini, 2007). Limited patient understanding of the potential health significance of a DFU and limited access to care may both have negative impacts (Mirmiran, 2000; Gale, 2008). Primary care providers perform complete foot examinations only infrequently (Wylie-Rosett, 1995; Winocour, 2002; O’Brien, 2003) and may lack the time or training (Winocour, 2002) to educate at-risk people about diabetes.
It is generally accepted that early diagnosis of risk factors associated with diabetic foot ulcers is a prerequisite for maintenance of lower limb health (Armstrong, 2007). International best practice guidelines recommend that people with diabetes be assessed on an annual basis for peripheral neuropathy and peripheral arterial disease using a range of simple screening tests (Bus, 2016).
A model to evaluate the effects of different types of interventions on economic outcomes in a theoretic cohort of 10,000 diabetic patients (Ollendorf, 1998) showed that prevention and appropriate management of diabetic foot patients might avoid up to 50% of amputations. The authors estimated that educational intervention, a multidisciplinary team approach, and therapeutic footwear could save from $2,900 to $4,442 in per patient costs (Driver, 2010).
Investing in evidence-based, internationally appropriate diabetic foot care guidance is likely among the most cost-effective forms of healthcare expenditure, provided it is goal-focused and properly implemented (Clinical Guidelines Task Force, 2003; van Houtum, 2005).
What is the prevalence of diabetes mellitus in the IDD population?
People with IDD are at higher risk of type 2 diabetes, which is attributed to obesity, reduced physical activity, elevated blood pressure and poor nutrition (Rey-Conde, 2007; Rimmer, 2006; McVilly, 2014). A systematic review by McVilly et al (2014) concluded that the prevalence of diabetes in people with IDD remains unknown (found a “mean prevalence” of 8.6%), although the evidence states that this population is at greater risk of developing diabetes. A further systematic review by MacRae et al (2015) suggested a prevalence rate of diabetes in the IDD population of about 10%. Examination of the Canadian population by Balogh et al (2015) found an inconsistent prevalence ranging from 7.1 to 19.4% (Havercamp, 2004; Reichard, 2011; Lunsky, 2011). The IDD cohort (Balogh, 2015) included 28,567 people between 30-69 years of age, and the comparison cohort included 2,261,919 people in the same age range generating rates of 16.0% of people with IDD with diabetes and 9.7% of people without IDD with diabetes (in the Canadian population). Women with IDD had a higher prevalence of diabetes (17.5%) than men with IDD (15.3%), but the opposite was true for people without IDD (men, 11.9%; women, 9.6%). This parallels findings from research on Special Olympics athletes which show that obesity, an important risk factor for diabetes, is higher among female athletes with IDD compared with males, as measured by BMI (Temple, 2014). Shireman et al (2010) used Medicaid data from Kansas to determine a diabetes prevalence among IDD individuals aged 31-50 years of 14.4%. Finally, Reichard et al (2011) suggests that individuals with IDD are vulnerable to prevalence rates of diabetes up to 5 times greater than the general population. What can be concluded from these statistics is the true prevalence of diabetes among the IDD population is not known, but what is known is that this population is extremely vulnerable to diabetes.
What podiatry conditions are more prevalent in the IDD population compared to the general population?
Foot health is characterized by a good blood circulation, absence of infection or inflammation, well-functioning sensation, and healthy skin and nails, which allow the foot to be used when mobilizing. Dysfunctions of the foot arise with abnormalities in structure, connective tissues, circulation, and the nerves supplying the foot. Even when the person cannot use the foot to mobilize, healthy tissues are important to prevent disease and avoid pain (Courtenay, 2015).
Foot health is affected by many factors that include general physical health, diseases of the foot, and physical activity that helps maintain tone and gives strength to the feet. Common health problems relevant to the foot include diabetes mellitus and peripheral vascular disease that predispose to poor circulation to the lower limbs that could lead to ulcer formation, infection, and disability. Specific disorders of the foot include bony abnormalities, such as clubfoot or hallux valgus (bunion formation). The shape of the foot is maintained by bones and the connecting tissues of ligaments and small muscles. Laxity of these structures can lead to flatfoot (a condition in which the arch of the instep is flattened so that the entire sole rests upon the ground), but physical activity can help strengthen the ligaments and muscles and therefore enhance mobility (Courtenay, 2015).
In a population sample in the UK, considering foot disorders and disability, 63% of respondents reported disorders of the foot and 10% complained of foot pain (Garrow et al, 2004). Molgard et al (2010) detected a prevalence rate of foot pain of 30.4% in a Danish sample. Hill et al (2008) in Australia reported on a sample in the general population where 17% experienced foot pain (Courtenay, 2015).
Disorders of the foot are associated with certain syndromes that are more common in people with ID (e.g. Down syndrome-DS). People with ID who do not have syndromic disorders have more foot problems than would be found among the general population (Prasher, 1995). Ill-fitting footwear and poor foot hygiene are important contributors to poor foot health by causing pressure on the foot or facilitating infections to develop on the skin (Jenkins, 2011).
In a community survey on access to health services by people with ID, Lennox et al (2000) found foot disorders and mobility problems among 50% of subjects. In the survey, 72% of people had known foot disorders that had not been assessed by a podiatrist. This raises an issue of access to healthcare in general and especially to foot care services (Courtenay, 2015).
The causes of the most common foot problems are lax ligaments, abnormal gait and movement, and skin conditions due to poor hygiene and ill-fitting footwear (Jenkins, 2011). Among Special Olympics with DS, the ankle joint was the second most common joint injury (Batts, 1998). The Fit Feet program of the SO prospectively collects data on the foot health of competing athletes at the SO events indicating that foot and ankle problems have a direct effect on performance. Conventional sports footwear is not always appropriate to the shape of athletes’ feet that can lead to injury and disability (Special Olympics, 2006).
Rationale Overview: The rationale overview answers the question, “why is it important to prevent diabetic foot complications in the IDD population?” The rationale behind the program plan is based on the economic impact on the healthcare system and the general lack of awareness of the lower extremity needs of the IDD population.
- Generate awareness of the lower extremity risk factors of the IDD population
- Risk Factors in the IDD population
- The IDD Population is At-Risk for DFUs due to lack of proper Diabetes Management
- Foot-shoe mismatch in IDD population: Another Risk Factor
- Awareness of Foot Problems & Effect on Quality of Life
- Impact of DFUs on Quality of Life
- Establish the economic impact of DFU on the healthcare system
- Economic Impact of DFUs
- Economic Rationale for preventing DFU
Risk Factors in the IDD population
People with disabilities are at disproportionate risk for obesity. Adults with a disability are 53% more likely to be obese (38.5% vs. 25.1%) than adults without a disability (Fox, 2014). Nearly half (46.7%) of adults who report ambulatory difficulty and about a third of adults with a cognitive limitation (32.7%) or visual limitation (34.5%) are obese (Fox, 2012).
The current experience of living with a disability is associated with more likelihood of not having a high school education (13% vs. 9.5%) and much less likelihood for employment (21% vs. 59%) (Warehouse, 2010), less access to the Internet (54% vs. 85%), much more likelihood of having an annual household income less than $15,000 (24% vs. 15%), and inadequate transportation (34% vs. 16%) (Kessler Foundation, 2010). Population research has consistently documented that women with disabilities receive lower rates of clinical preventative services such as mammograms (Parish, 2006; McCarthy, 2006), and receive differential treatment of detected cancers (McCarthy, 2006; Iezzoni, 2008).
The IDD population has a high prevalence of biomechanical abnormalities that can predispose them to an imbalance of pressure on the bottom of the foot, leading to ulceration. Jenkins et al (2010 & 2014) analyzed data from Special Olympics athletes to determine the prevalence of biomechanical abnormalities in this population and found they had higher prevalence of such deformities compared to the general population. Additionally, when comparing Special Olympics data internationally, they also found that U.S. Special Olympics Athletes had higher prevalence of deformities than an Athens, Greece cohort (from the International Games).
The IDD Population is At-Risk for DFUs due to lack of proper Diabetes Management
Optimum diabetes management requires considerable self-care involving a number of practical tasks, e.g. choosing appropriate foods and portion sizes, monitoring and interpreting blood glucose levels, being physically active and taking medications (Reed, 2003). People with IDD experience challenges with such tasks (AAIDD), and can be overwhelmed by them (Dysch, 2012). Consequently, they rely on the support of others (AAIDD). An emerging literature suggests that for many people with IDD, optimum diabetes care is not achieved (Rey-Conde, 2007; Cardol, 2012; Taggart 2013). The apparent shortcomings in diabetes-related care might reflect: broader unmet healthcare needs among people with IDD (Lennox, 2000; Melville, 2006; Valk, 2002); complications associated with detecting pain (Beacroft, 2010); diagnostic overshadowing (Jopp, 2001); comparatively low rates of participation in health screening and health promotion (Valk, 2008; Turk, 2010); and insufficient training of health professionals in how to relate to, communicate with and adapt health service provision for people with IDD (Cardol, 2012; Melville, 2006). Overall, however, it is evident that diabetes management in people with IDD should be a matter of concern for policy makers, healthcare professionals and educators (McVilly, 2014).
Diabetes and the risk for DFUs in the IDD population is concerning because this population generally lacks the ability and/or resources to properly manage diabetes. Cardol et al (2012) reported that individuals with IDD struggle with self-management of diabetes and this is especially true of individuals with communal living arrangements. They found that self-management of diabetes is more difficult because of strict daily timetables, food being prepared for them, and the temptation of seeing others eat. Additionally, Cardol et al (2012) found that for individuals living alone, there appeared to be a relationship between a better understanding of diabetes and self-management (but only those living alone). Cardol reported that of the individuals in their study, not a single individual reported receiving diabetes information that they could understand (Cardol, 2012) while another study noted that participants could not recall receiving any diabetes information at all upon diagnosis (Hale, 2011).
It has been suggested that caregivers may not themselves have sufficient knowledge and skills to educate people with IDD to self-manage their diabetes (Cardol, 2012). Cardol et al (2012) discovered that individuals with IDD and diabetes appreciated being accompanied by their support worker or professional staff to healthcare appointments, as it meant that health information could be explained again later. Low literacy diabetes education materials (e.g. pictorial guides) would be of great benefit to this population.
Since self-management of diabetes can be challenging for the IDD population, it will be necessary for clinicians and researchers to devise management programs targeted for this population that consider their unique cognitive and functional limitations. Besides self-care, healthcare providers must be cognizant of the effects of psychotropic medications on weight gain and secondary metabolic complications (Bhaumik, 2005; Reiss, 2007); this is particularly relevant for antipsychotic medications, which are frequently prescribed among people with IDD (De Kuijper, 2010). Furthermore, it is important that these medications be prescribed only when clinically necessary, and not simply for the treatment of routine problem behavior (De Kuijper, 2010).
Foot-shoe mismatch in IDD population: Another Risk Factor
A prominent risk factor for DFU formation is ill-fitting shoes. An examination and analysis done by Jenkins et al (2012) found that the IDD population has a high percentage of misfitting shoes. Jenkins screened Special Olympics athletes and found that proper fitting shoes was found in 58.56% of the athletes, with 28.60% wearing shoes too big and 12.84% wearing shoes too small. The mismatched category includes shoe size any amount too small for the foot. Based on this categorization, 41.44% of the athletes had a shoe-to-foot size mismatch (Jenkins, 2012). The percentage of athletes who wore smaller-than-optimal shoes (12.84%) is much smaller (less than half) than that of athletes who wore larger-than-optimal shoes (28.60%) and this may reflect the need to accommodate foot deformities within the shoe (Jenkins et al, 2012).
Conditions that may have associated shoe-fitting difficulties include metatarsus adductus, hallux varus, brachymetatarsia, tailor’s bunion, and cavus. Many of the previously mentioned conditions have a high prevalence in these athletes, and this would indicate the great importance of properly fitted shoes (Jenkins, 2011; 2012). The lower occurrence of shoes too small may indicate that socioeconomic factors are not preventing procurement of larger shoes as the athlete grows (Jenkins, 2012). Based on a survey by the Prescription Footwear Association, Rossi (1983) concludes that nearly 100% of the population has a right foot different than the left (mismatched feet), which can further complicate the achievement of proper shoe fit (Jenkins, 2012).
Studies regarding proper fit in the general population are scarce (Jenkins, 2012). Some studies have looked at rates of ill-fitting shoes, but most look at persons with diabetes or elderly populations (Burns 2002; Paiva de Castro, 2010; Nixon, 2006). In these studies, the rates were very high, with Burns et al (Burns, 2002) noting that 72% of patients were using ill-fitting shoes. Only 6% of that value included those with a shoe too small (Burns, 2002). Paiva de Castro et al (2010) found that 57.3% of patients wore ill-fitting shoes in their study populations, and similar to the study by Burns, those with a shoe too small were negligible. Nixon et al (2006) in their study of a US Veterans Affairs population (94% male and 58.4% diabetic), noted that 74.5% of participants wore improperly sized shoes.
Awareness of Foot Problems & Effect on Quality of Life
Foot problems and foot pain are common (Menz, 2005; Greenberg, 1994) , whilst corns can be found in 14-48% of people (Farndon, 2006). Large epidemiological surveys report a high prevalence of foot problems and pathologies: of 76, 475 people attending a dermatology or general practice department, just over half (57%) had a foot disease (Katsambas, 2005). The most common were general skin conditions (eczema, psoriasis, fungal infections) and metatarsal corns. A systematic review found that women have higher incidences of foot/ankle pain which is age-related, and two-thirds of cases reported moderate disabilities as a result of this which affected daily life (Thomas, 2011). Foot problems are associated with pain and can affect quality of life. A large survey of 3206 people found that the 17% of who reported foot pain scored lower across all domains on a standard quality of life measure (SF-36) (Hill, 2008). “Foot trouble” was the single most cited factor affecting activities of daily living in a small study of older people (Bowling, 1997), which found a statistically significant association between foot problems and pain, and activities of daily living was identified (Benvenuti, 1995). Foot pain and function are therefore strongly correlated (Bennett, 1998).
The ability to mobilize is dependent on functioning muscles, bones, and ligaments working in proper alignment. For some people, however, independent mobility is not always possible because of neuromuscular disorders or lower limb deformities. Lifelong attention to the health status of feet is important in order to treat foot disorders, relieve discomfort, and maintain good general health (Courtenay, 2015). Generally, ID has been associated with poorer health status and outcomes than in the general population (Cooper, 2004). Issues in the management of foot problems include awareness by caregivers and podiatrists of foot disorders in people with IDD, effective communication with the person, and the assessment of mental capacity by podiatrists when proposing interventions to manage the problems (Courtenay, 2015).
Impact of DFUs on Quality of Life
There can be little doubt that diabetic foot disease has psychological and behavioral consequences for the individual. In terms of psychology, data suggest that over a third of individuals are anxious or depressed (Udovichenko, 2017). The rates of psychological morbidity may be even higher in people with Charcot foot (Chapman, 2014). Health-related quality of life is significantly impaired in people with both healed and unhealed ulcers, compared with the general population and individuals with diabetes but no history of ulceration (Goodridge, 2006), and, perhaps, not surprisingly, significant deteriorations in quality of life are evident in those with non-healing ulcers (Winkley, 2009).
In terms of psychological determinants, several studies have explored the relationship between mood and related psychological constructs with ulcer risk, healing, amputation and mortality. For example, large cohort studies suggest that depression is associated with a two- to threefold increase in incident foot ulcers (Iversen, 2015, Williams, 2010). Gonzalez et al (2010) reported that depression predicts first ulcers, but not their recurrence, while Monami et al (2008) reported that ulcer recurrence over 12 months was significantly associated with depression. A number of studies have examined the relationship between indices of psychological functioning and mortality. Depression, health-related quality of life and patients beliefs regarding their ulcers, all predict mortality (Siersma, 2014; Winkley, 2012; Vedhara, 2014). Multiple large-scale studies of patient self-reported quality of life have shown that limb loss has a larger negative impact on quality of life than any other complication of diabetes, including end-stage renal disease or blindness (Clarke, 2002; Laiteerapong, 2011). In addition to the loss of mobility and independence (Taylor, 2005; Nehler, 2003), depression and anxiety are very prevalent among people with diabetes who have experienced limb loss (Darnall, 2005; Singh, 2009; Williams, 2011).
It is clear that psychological and behavioral factors influence ulcer outcomes (Clokie, 2016). However, interventions in diabetic foot interventions focus overwhelmingly on education instead of psychological and behavioral factors. This is despite the fact that successive systematic reviews have not found that education improves clinical outcomes (Mason, 1999; O’Meara, 1999; Valk, 2002; Dorresteijn, 2012; Hunt, 2011).
Economic Impact of DFUs
The economic costs associated with diabetic foot care, including amputation care, represent the single largest category of excess medical costs associated with diabetes (ADA, 2008). In 2007, diabetes and its complications cost the United States $174 billion; $116 billion were in direct costs and $58.3 billion in indirect costs such as loss of productivity, disability, and premature mortality (American Diabetes Association, 2007). Peripheral vascular complications and neurologic complications, which are closely linked to foot ulceration, accounted for 31% and 24% of the expenses, respectively, and were among major contributors to hospital inpatient length of stay (Driver, 2010). The total cost for diabetic foot care for those with neuropathy has been estimated to be $11 billion (Gordis, 2003).
Even conservatively extrapolating these figures to include those with diabetes and peripheral arterial disease (PAD) would increase the total cost estimate to $17 billion, comparable to the annual costs of breast cancer and colorectal cancer (National Cancer Institute) (Barshes, 2013).
(Table from: Barshes, 2013)
(Chart from: Barshes, 2013)
An analysis of Medicare claims data from 1995 to 1996 showed that expenditures for diabetic foot patients were three times higher than for the general population ($15,309 vs. $5226), yielding a total cost for Medicare in 1995 of $1.5 billion (Harrington, 2000). Lower extremity ulcers accounted for 24% of the overall cost for the diabetic population with inpatient stays accounting for 73% of increased cost (Harrington, 2000).
Economic Rationale for preventing DFU: Once a DFU is present, the economic costs skyrocket compared to diabetes care without a DFU
A retrospective study by Ramsey demonstrated that the relative cost of care for diabetic patient with lower extremity ulcers ranges from 1.5 to 2.4 times higher than that of diabetic patients without an ulcer (Ramsey, 1999). Excess cost was $26,490 in ulcer patients and $4927 for diabetic patients without an ulcer. Additionally, Driver found that the costs for diabetic foot ulcer patients were $17,245 compared with $5110 for diabetic patients with no ulcer (Driver, 2010).
Apelqvist et al (1995) prospectively monitored 314 patients with an ulcer episode. They documented that 54% of patients healed in 2 months, 19% healed in 3 to 4 months, and 27% healed in 5 or more months. Healing without amputation averaged $6664, whereas healing by amputation averaged $44,790 (in 1995 dollars). Hospitalization costs and topical treatment of ulcers accounted for most of the costs. Apelqvist also estimated that the long-term costs of diabetic foot ulcers remain elevated during the first 3 years after healing of an ulcer (Apelqvist, 1995). This concludes that once an ulcer is present, the increased costs associated with treatment can last for several years (Driver, 2010).
Higher grade lesions and peripheral arterial disease not only lead to higher amputation rates but are also associated with higher costs of care mainly due to higher hospitalization rates and longer length of stay. A retrospective study by Stockl (2004) of diabetic patients with lower extremity ulcers revealed an average cost per ulcer episode of $13,179. There was an increase in cost according to ulcer depth as evaluated by the Wagner classification system. Costs associated with a Wagner grade 1 ulcer averaged $1892, and Wagner grade 4&5 ulcers averaged $27,721. This study confirmed the high impact of inpatient stay as being 77% of the overall cost. Progression from Wagner ulcers with lower grades to higher grades carried an additional increase in cost of $20,136 (Stockl, 2004). The study also confirmed a higher cost per ulcer episode in patients with poor vascular status. Patients with diabetic foot ulcers have an average hospital length of stay that can be 50% higher than that of patients without an ulcer (Reiber, 1995).
Additionally, in the United Kingdom, diabetes-related foot disease accounts for approximately £1 in every £150 spent in the National Health Service (Kerr, 2014). The estimated cost of treating a foot ulcer was approximately £10,000 in one large European study (Prompers, 2008).
Economic factors related to diabetic foot disease will play an ever-increasing role because third-party payers cannot reimburse all therapies used to treat chronic ulcerations (Driver, 2010)
Design & Methods
Overview: The Design & Methods section addresses the plan for the program. Eight subsections address the program initiatives including vision, mission, objectives, and activities.
1) Situation Statement
2) Program Goals
3) Audience and Potential Stakeholders
4) Program Overview & Description of Vision, Mission, & Objectives
5) Program Activities
6) Timeline for Program Implementation – See conclusion section
7) Program Evaluation & Measures of Progress - See conclusion section
8) Vision for Data Utilization
1) Situation Statement
The prevalence of diabetes mellitus and the increase of diabetic foot disease in the U.S. population as a whole is a public health concern that requires a proactive approach to prevention. The IDD population is at increased risk for diabetes and foot problems compared to the general population.
2) Program Goals
- Train podiatry students to implement and perform foot screenings at health fairs and group homes for the IDD population
- Collect demographic and observational data about the lower extremity in the IDD population
- Establish the prevalence of DM & foot conditions in a cohort of IDD individuals
- Educate IDD individuals, healthcare providers, and caregivers about common foot abnormalities experienced by the IDD population
- Empower individuals with IDD to care for their feet and be equipped to prevent risk factors from progressing to more serious disease
- Enhance access to podiatry services by removing barriers to access and increasing knowledge of preventative care
3) Audience & Potential Stakeholders
- Individuals with intellectual & developmental disabilities
- Group homes, families, & caregivers of IDD individuals
- Non-profit organizations concerned with public health, podiatry, and the IDD population
- Special Olympics
- American Diabetes Association
- American Public Health Association
- American Podiatric Medical Association
- Healthcare providers, particularly podiatrists
- Public Health professionals concerned with reducing health disparities
- Policy makers providing podiatry services, access to preventative care, and disability research
4) Program Overview & Description of Vision, Mission, & Objectives
- A) Vision: To prevent the onset and consequences of diabetic foot disease in the Intellectually & Developmentally Disabled population.
- B) Mission: To screen the IDD population for risk factors of diabetic foot disease and to educate preventative foot care. The goal is to educate podiatrists and other healthcare providers about the lower extremity needs of the IDD population as well as to empower the IDD population to recognize warning signs and seek care before a major problem arises. The main mission is to provide a public health prevention program to reduce foot and ankle related morbidity and mortality.
- C) Program Description
The program utilizes volunteer podiatry students trained to provide foot examinations and educate IDD individuals and their caregivers on diabetes manifestations in the feet and preventative foot care. Students examine the various systems of the feet including biomechanical, dermatological, vascular, and assess gait. The results will be analyzed to establish risk for diabetes mellitus and foot complications. In addition to foot screening and education, students will administer two surveys, one to assess risk for prediabetes (from the Diabetes Prevention Program) and a foot pain/functionality survey. The results of the surveys will be used to tailor program activities to the particular foot and ankle needs of the IDD population.
- D) Objectives
- Improve access and health care for IDD individuals
- Make referrals to local health practitioners when appropriate,
- Train health care professionals and students in the health professions about the needs and care of people with intellectual disabilities,
- Collect, analyze and disseminate data on the health status and needs of people with intellectual disabilities
- Advocate for improved health policies and programs for persons with intellectual disabilities.
5) Program Activities
The program activities subsection details of the activities utilized to accomplish the goals and objectives laid out in the previous sections. The logic model below demonstrates the inputs, activities, outputs and expected outcomes of the program. The activities address one or more of five main strategies: A) providing information & enhancing skills, B) enhancing services & support, C) modify access, barriers, and opportunities, D) tailor services to the specific needs of the audience, E) modify policies.
- A) Program Plan Logic Model
HappeeFeet Program Plan
Foot Screening Materials
Database & Technology
Training & Education Materials
1) Develop training material
Education materials to teach diabetic foot screenings & communication with IDD pop.
Improved student knowledge & recognition of foot problems; empathy & communication skills
2) Train students for foot screening
Students equipped to identify risk factors for DM foot
Objective foot screenings identify early changes that can be prevented
3) Perform Risk Assessment through foot screening; collecting objective data
Establish a risk stratification for DM foot & IDD by observing trends in objective data
Education & possible referral for high risk individuals
4) Develop survey self-assessing foot pain and function for IDD individuals
Assess the perceived foot health needs and barriers to activities of daily living related to the foot
Improve healthcare provider knowledge of foot care needs of IDD population; tailor services to address needs & disparities
5) Produce & Distribute IDD foot-specific education material
Empower IDD individuals & caregivers to prevent common foot problems
Decreased foot pain & problems; improved quality of life; remove barriers to activities of daily living
6) Assess screening & survey data for prevalence rates of podiatry conditions
Identify prevalence rates of podiatry conditions in an IDD cohort
Contribute to podiatry & disability services public health knowledge
7) Referral of high risk individuals to Foot Center of New York
Provide access to a foot & ankle treatment center
Reduced serious foot complications; increased usage of prevention service
- B) Program Activities
- Develop Student Training Material
- Train Students for Foot Screening
- Perform Risk Assessment & Data Collection Through Foot Screening
- Develop a Survey Assessing Perceived Foot Pain & Function
- Assess Screening & Survey Data for Prevalence Rates in IDD
- Referral of High-Risk Individuals to Local Providers
A description of the activity and evidence-basis for inclusion can be found in the Results section.
6) Timeline for Program Implementation
Please see conclusion section for the timeline and plan for program implementation.
7) Program Evaluation & Measures of Progress
Please see conclusion section for the timeline and plan for program evaluation.
8) Vision for Data Utilization
Once the data gathered from the program has been analyzed, the results will be used to write guidelines for improving treatment, communication, and intervention strategies in the IDD population. Additionally, the data will contribute to the research and clinical knowledge basis for intellectual disability research, podiatry interventions, and prevention of disabling foot conditions.
Results Overview: The results section provides the reasoning and rationale behind the objectives and activities described in the program plan. The rationale is based on a literature review tailored towards the IDD population with a focus on preventative strategies. The results section combines the areas of diabetic wound care, podiatric medicine, intellectual disability research, and public health promotion and prevention. Each italicized subsection is correlated with an activity of the program plan and provides the evidence and thought process behind each.
- Establish the rationale and/or evidence basis behind each program activity
- Develop Student Training Material
- Prevention of DFUs
- DFU Primary Prevention: identifying and modifying DFU risk factors to avoid DFU occurrence
- DFU Secondary Prevention: avoiding delays in the recognition of DFUs
- Train Students for Foot Screening
- How to do a 3-minute diabetic foot exam,
- Perform Risk Assessment & Data Collection Through Foot Screening
- Risk Assessment
- Risk Factors for Development of Diabetic Foot Ulcer (DFU
- Risk Factors for Limb Loss
- Develop a Survey Assessing Perceived Foot Pain & Function
- What is the Bristol Foot Score?
- Why Use the Bristol Foot Score?
- Other Questionnaires for Foot Health
- Assess Screening & Survey Data for Prevalence Rates in IDD
- Need for more research into IDD foot pathology
- Special Olympics Fit Feet Program – A Model Foot Screening Initiative for IDD
- Findings from Special Olympics Data by Jenkins on foot pathology in IDD
- Referral of High-Risk Individuals to Local Providers
- Podiatry’s Role in Preventing DFUs in the IDD Population
1) Develop Student Training Material
Training is based on DFU podiatry prevention protocols established internationally
DFU primary prevention.
Prevention of DFUs
Barshes (2013) describes primary, secondary, and tertiary prevention models for DFU. Primary prevention includes identifying and modifying DFU risk factors to avoid DFU occurrence. Secondary prevention is avoiding delays in the recognition of DFUs. Tertiary prevention is ensuring adequate DFU treatment. Since the goal in the IDD population is to prevent the initial occurrence of a DFU, the focus will be on primary prevention, with very little discussion of secondary and tertiary prevention models.
(Table from: Barshes, 2013)
Systemic manifestations of diabetes often present first in the foot (Lauterbach, 2010). Callus formation on the foot indicates abnormal areas of pressure or shear. Regular debridement of callus as well as shoe gear modification can prevent progression to ulceration (Boulton, 1999). Typically, the underlying problem involves some level of biomechanical fault involving joint immobility (Zimny, 2004; Fernando, 1991). Ultimately, preventative care by a podiatrist can curtail the progression from a biomechanical abnormality to benign callus to limb loss (Rijken, 1999; Muha, 1999; Pinzur, 2005; Spencer, 2000). Podiatric services are the frontline defense against this process (Kim, 2012).
(Table from: Singh, 2005)
DFU Primary Prevention: identifying and modifying DFU risk factors to avoid DFU occurrence
Structural foot abnormalities, PAD, and neuropathy are irreversible. Primary prevention efforts have therefore focused on the identification of risk factors, patient education and the promotion of certain health behaviors to minimize foot trauma and avoid delayed presentation. Foot-protective health behaviors often taught to patients with diabetes focus on minimizing the foot trauma through avoidance of barefoot walking, wearing shoes with improper fit, and stepping into bath water without checking the temperature, and monitoring the variability of walking and other activities (Armstrong, 2004). Between 40 and 90% of patients with neuropathy are unaware of having it (Holewski, 1989; Bongaerts, 2013); these foot protective behaviors might be especially beneficial to these patients who are unaware of their impaired protective sensation and its potential consequences (Barshes, 2013).
(Table from: Singh, 2005)
The effectiveness of patient education on the prevention of DFUs has been analyzed in a Cochrane database review (Dorresteijn, 2010). The review concluded that patient education interventions may improve patients’ understanding of foot complications and adherence to certain health behaviors, but there was no consistent evidence to suggest a reduction in the incidence of DFU formation or lower extremity amputation. Only one trial (Corbett, 2003) included in the review focused exclusively on primary prevention (i.e. prevention of a DFU among at-risk patients without a previous history of DFU) (Barshes, 2013).
Mitigating the effects of structural foot abnormalities has been another approach to DFU primary prevention efforts. One randomized clinical trial (Weintraub, 2003) and at least two non-randomized studies (Albert, 1993; Lobmann, 2001) have examined the use of insoles among people with diabetes without a history of previous DFU but who were considered high risk because of pronation, neuropathy, and/or elevated peak plantar pressures. The use of insoles does appear to decrease peak plantar pressures in these studies, but it has not been clearly demonstrated that this translates to a significant reduction in DFU formation (Barshes, 2013).
DFU Secondary Prevention: avoiding delays in the recognition of DFUs
Many patient-related barriers to prompt recognition of DFUs exist. One study of veterans with diabetes found that only 32% examined their feet on a daily basis (Olson, 2009). A daily self-foot examination is not likely to be done or be helpful if patients have not been instructed to do these examinations or if the patient does not know what an “ulcer” or other foot abnormalities looks like (Gale, 2008). Visual impairment, poor balance/equilibrium, decreased limb flexibility, and obesity may also limit a patient’s ability to examine the plantar aspect of their foot and recognize the abnormalities. Even when abnormalities are found, patients may not immediately seek medical attention because they are unaware of the relationship between DFUs and limb loss, have limited access to medical care (Feinglass, 2012), or do not know what type of provider to see (Mirmiran, 2000). U.S. patients with lower socioeconomic status have a higher risk of limb loss (Margolis, 2011), and this does not appear to be related to the prevalence of physicians and/or podiatrists in a given area (Margolis, 2011). Patients with recognized DFUs should generally be referred for multidisciplinary specialist foot care, but these referral are frequently delayed or absent. In the EuroDIALE study, for example, 27% of the patients were referred to a specialist foot clinic only after the DFU had been present for more than 3 months. Specialist referrals varied widely not only between countries but also among centers within a country (Prompers, 2008). Such delays can negatively impact outcomes (Mills, 1991).
2) Train Students for Foot Screening
How to do a 3-minute diabetic foot exam, Miller et al, 2014
Unfortunately, patients often have difficulty recognizing the heightened risk status that accompanies the diagnosis of diabetes, particularly the substantial risk for lower limb complications (Sloan, 2010). Strong evidence suggest that consistent provision of foot-care services and preventative care can reduce amputations among patients with diabetes (Sloan, 2010; Carls, 2011; McCabe, 1998). Data suggest that the diabetic foot is adequately evaluated only 12% to 20% of the time (Bailey, 1985). Therefore, Miller et al developed an exam that could be done by a wide range of health care providers that takes substantially less time to complete than a comprehensive exam and eliminates common barriers to frequent assessment. The components of the exam are: A) patient history (1 minute), B) physical examination (1 minute), C) patient education (1 minute).
- A) The patient history: A thorough medical history can identify factors that may increase patients’ risk of developing lower-limb complications. Review the patient’s diabetic history, blood glucose control, and previous diabetic complications. Ask patients about their history of peripheral vascular disease, quality of peripheral protective sensation, and previous lower-limb interventions and operations. Patients with diabetes and sub-optimal glycemic control have an increased risk for loss of protective sensation, chronic and recalcitrant ulcers, and wound infections (Apelqvist, 2000).
- B) Physical examination: Since up to 50% of patients with significant sensory loss due to neuropathy may be completely asymptomatic (Boulton, 2005), failing to search for early signs of infection, skin breakdown, ulcer formation, skin temperature changes, and inadequate vascular perfusion may allow complications to develop (Boulton, 2005). The essential components of the exam include dermatologic, neurologic, musculoskeletal, and vascular assessments.
- Dermatologic exam: Begin with a global inspection for discolorations, calluses, wounds, fissures, macerations, nail dystrophy, or paronychia (Boulton, 2005). Skin discoloration or loss of hair growth may be the first signs of vascular insufficiency, while calluses and hypertrophic skin often are precursors to ulcers (Boulton, 2005; Marso, 2006; ADA, 2005; Pataky, 2002). Inspection of the toes should include a search for fungal, ingrown, or elongated nails. Carefully examine the areas between the toes, where deeper lesions may go unnoticed (Boulton, 2005).
- Neurologic exam: Without protective sensation, patients with neuropathy are at a heightened risk of unrecognized injury and are unlikely to mention their deformities to medical staff (Holzer, 1998; Boulton, 1998; Malay, 2006; van Houtum, 2012). A diminished vibratory perception threshold (VPT) is one of the earliest indicators of neuropathic loss of protective sensation and is the best predictor of long-term lower extremity complications (Shearer, 2003; Jayaprakash, 2011; Young, 1993).
- Neuromuscular/musckuloskeletal exam: Musculoskeletal deformities asuch as a hammer toe, claw toe, or bunion can cause significant pain and/or gait disturbance, and can increase patients’ risk for ulceration (Lavery, 1998). Therefore, patients who present with previously unreported musculoskeletal deformities should be referred to a specialist (Frykberg, 2006).
- C) Patient education: Patient education improves patients’ self-reported home care behaviors, even at the most fundamental levels (Lincoln, 2008; McMurray, 2002). Patients’ lack of understanding about self-care for diabetes is a common barrier to prevention (van Houtum, 2012). El-Nahas et al (2008) found a lack of appropriate education regarding diabetes was a factor in more than 90% of recurrent ulcers, which emphasizes the need for repeated education for at-risk patients (Hamalainen, 1998; Ronnemaa, 1997)
The following three charts demonstrate how to conduct each part of the exam.
(Diagrams from: Miller, 2013; Reference 5 = Boulton, 2008; Ref 12= Abbott, 2002; Ref 15= Singh, 2005; Ref 16=Pham, 2000; Ref 45= Armstrong, 1998)
3) Perform Risk Assessment & Data Collection Through Foot Screening
After completing the 3-minute foot exam, create a treatment and follow-up plan, focusing on the need for referral to a specialist. The following table outlines suggested indications, priorities, and timelines for referral based on ADA guidelines (Boulton, 2008). It incorporates the ADA’s patient risk categories (very low, low, moderate, and high risk) and also provides a recommended frequency for patient follow-ups.
(Table from: Miller, 2013; Reference 5 = Boulton, 2008)
(Table from: Boulton, 2008)
“The prevalence of foot disorders in people with ID is uncertain because of few epidemiological studies” (Courtenay, 2015). With this understanding, it is necessary to collect more data on the IDD population and determine the feasibility of diabetes foot management in the IDD population.
Bus & van Netten pose a critical question: Can we prevent a first foot ulcer? In all prospective studies and risk classifications, persons with a previous foot ulcer are found to be at the highest risk for future ulceration (Monteiro-Soares, 2011). Reported ulcer recurrence rates are 30-40% in the first year after an ulcer episode (Pound, 2005, Bus, 2013), compared with 7.5% annual incidence for patients with peripheral neuropathy and no ulcer history (Abbott, 2002). Thus, if the first ulcer is prevented or postponed, ulcer incidence rates will drop substantially. Because the evidence base for prevention of a first foot ulcer is practically non-existent (van Netten, 2015), we need to ask ourselves if we can prevent a first foot ulcer in persons with diabetes. Some interventions have been studied, such as foot screening, treatment of pre-signs of foot ulceration, advice on proper footwear, and patient education, and are listed in the IWGDF Guidance on Prevention (Bus, 2015), but the use of these interventions is based on low quality of evidence or expert opinion. There are indications that home monitoring of foot temperature, therapeutic footwear, and advice within an education session that patients adhere to can help (van Netten, 2015).
Risk Factors for Development of Diabetic Foot Ulcer (DFU)
Risk factors for developing a DFU include: neuropathy, poor circulation (PAD), foot deformity (e.g. bunion, hammer toe), inappropriate shoes, uncontrolled blood sugar, and a history of a previous foot ulceration or amputation, visual impairment, and diabetic nephropathy (especially patients on dialysis). Additional, controllable risk factors, include smoking, drinking alcohol, high cholesterol, and elevated blood glucose (APMA – Wound Care).
Three factors consistently play an important role in the development of DFUs: structural foot abnormalities, sensory neuropathy, and peripheral artery disease (PAD). First, the feet of people with diabetes often undergo characteristic structural changes that are the consequence of autonomic and motor neuropathies, intrinsic muscle atrophy, and reduced joint/tendon mobility (Barshes, 2013). The end result of these structural abnormalities is an unequal distribution of stress on the plantar surface of the foot during the gait cycle (Cavanagh, 2010), which in turn predisposes prominent areas of the foot to repetitive trauma and ultimately full-thickness skin ulceration (LoGerfo, 1984).
Peripheral sensory neuropathy (also referred to as loss of protective sensation) is a second important factor that leads to DFUs in that it decreases or eliminates the nociceptive response that would typically be protective against repetitive trauma occurring during the gait cycle. The prevalence of sensory neuropathy in diabetic populations in the United States and United Kingdom typically ranges between 40 and 60% (Young, 1993; Dyck, 1993; Pham, 2000; Moulik, 2003; Boyko, 2006) and denotes up to a twofold higher relative risk of DFU incidence (Boyko, 2006; Lavery, 2008). The presence of PAD also has a major influence on the development of DFUs (Lavery, 2008; Boyko, 2006). The incidence of PAD in the general diabetic population is 20-30%, at least twofold higher than that of non-diabetics (Barshes, 2013). Among those with existent DFUs, the incidence of PAD reaches 50% (Marso 2006; Norgren, 2007; Prompers, 2008).
(Table from: Gordis, 2003)
Risk Factors for Limb Loss
PAD, diabetes, and peripheral neuropathy are three important risk factors that frequently overlap in patients and lead to an increased risk for limb loss. This is due to the lack of sensation that allows the skin to break down and easily become infected. Once an infection has taken hold, the lack of blood flow from PAD makes it difficult for the body to clear the infection. It is the combination of infection and ischemia (lack of blood flow) that ultimately contributes to the patient losing part of their limb. Other important risk factors for limb loss include end-stage renal disease (Margolis, 2008; Ndip, 2010), autonomic neuropathy (Tentolouris, 2009; Tentolouris, 2010), and depressive symptoms (Gonzalez, 2010; Williams, 2010). Poor glycemic control has a well-recognized role in the development of peripheral sensory neuropathy (NEJM 1993) and therefore has at least some causal role in the development of DFUs. It is unclear if glycemic control has a significant impact of limb loss risk independent of the presence or absence of neuropathy, however (Litzelman, 1997; Lavery, 1998).
4) Develop a Survey Assessing Perceived Foot Pain & Function in IDD Population
The Bristol Foot Score: Developing a Patient-Based Foot-Health Measure. Barnett, Campbell, & Harvey, 2005.
What is the Bristol Foot Score?
Although probable-free feet are taken for granted and largely ignored, more than 50% of people older than 45 years perceive that they have a foot problem (Brodie, 1988). Individual perception of foot health has a significant effect on the demand for foot-health services (Stevens, 1994). Four of five people 65 years or older have at least one foot problem, and approximately half need podiatry service, but only half of these people currently receive treatment (Pushpangadan, 1996; Harvey, 1997). Although the degree of pathologic change may affect the patient’s mobility, comfort, and freedom of choice, the patient’s perception of his or her foot health does not necessarily relate to the level of foot pathology as assessed by medical practitioners (Brodie, 1988). This is an important phenomenon, and if evaluative research in podiatric medicine is to advance, then the development of patient-generated foot-health outcome measures that capture the patient’s foot-health expectations, perceptions, and experiences is an urgent task. There is now general recognition among health-services researchers that measures of health outcome should incorporate the patient’s perspective (Bowling, 1996) and that this approach enables the provision of more responsive, equitable care (Campbell, 2005).
The Bristol Foot Score (BFS) was generated by combining approximately 90 statements about foot problems and are grouped under five sections: 1) Mobility 2) Pain 3)Footwear 4) Foot health and disability 5) Perception of self as a result of foot problems. The initial version of BFS consisted of 41 questions, all using a Likert response format, involving levels of agreement or disagreement with an initial statement. The current version (fifth) (Found in Appendix) consists of 15 questions focused on 3 main factors: A) concerns about feet and pain, B) footwear and general foot health, C) mobility. The scoring system of the BFS assigns a score from 1 (best possible situation). This gives the possibility of a range of scores between 15 (best) and 73 (worst).
Why Use the Bristol Foot Score?
Discrepancies between professional- and patient-perceived need for foot health care have been observed in other studies (Brodie, 1988), and, anecdotally, medical practitioners often observe that patients with the least severe foot pathologies seem to be troubled beyond professional expectations. This information provides valuable additional contribution to professional foot health status scores and potentially uncovers subtle psychological factors that influence behavior and outcomes.
Other Questionnaires for Foot Health
The Foot Function Index (Budiman-Mak, 1991) was designed specifically to examine the efficacy of foot orthoses in patients with rheumatoid arthritis. The Foot Health Status Questionnaire (Bennett, 1998) was developed using the expert opinion of podiatric surgeons, who determined the content of the questionnaire. The Manchester Foot Pain and Disability Schedule, produced by Garrow et al (2000), was designed to assess disabling foot pain. The Manchester questionnaire has the primary objective to enable identification of individuals with a wide range of disabilities associated with their foot pain, rather than to produce a tool that is sensitive to change. The BFS is most similar to the Manchester Foot Pain and Disability Schedule in that it was developed from the patient’s perspective; however, rather than being a tool designed for identification purposes only, the BFS is also designed to measure change. The BFS is self-administered, removing the risk of inter-rater variations. The entire questionnaire can be completed within 3 to 5 minutes, encouraging better response levels. As a generic foot health outcome measure, the BFS can be used for all types of patient groups, all aspects of foot pathology, and all therapeutic and surgical interventions (Campbell, 2005).
5) Assess Screening & Survey Data for Prevalence Rates in IDD
Need for more research into IDD foot pathology
Further research on foot problems in people with ID is required to understand the prevalence of foot disorders, their characteristics, and the application of effective treatments tailored to the needs of people with ID. It will be important to learn what factors in the lives of people with ID contribute to the development of foot disorders and how they can be supported to avail current treatments (Courtenay, 2015).
Special Olympics Fit Feet Program – A Model Foot Screening Initiative for IDD
Mission Statement (of SO) – to provide year-round sports training and athletic competition in a variety of Olympic-type sports for individuals with intellectual disabilities by giving them continuing opportunities to develop physical fitness, demonstrate courage, experience joy, and participate in a sharing of gifts, skills, and friendship with their families, other Special Olympics athletes and the community.
Goal – for all persons with intellectual disabilities to have the chance to become useful and productive citizens who are accepted and respected in their communities. The benefits of participation in Special Olympics for people with intellectual disabilities include improved physical fitness and motor skills, greater self-confidence, a more positive self-image, friendships, and increased family support. Healthcare professionals benefit by learning about the health needs of Special Olympics athletes and gain confidence and satisfaction in volunteering their skills to an underserved population.
Fit Feet Objectives:
- Improve access and health care for Special Olympics athletes at event-based health screenings,
- Make referrals to local health practitioners when appropriate,
- Train health care professionals and students in the health professions about the needs and care of people with intellectual disabilities,
- Collect, analyze and disseminate data on the health status and needs of people with intellectual disabilities
- Advocate for improved health policies and programs for persons with intellectual disabilities.
Fit Feet Goals:
- To continue to expand the Fit Feet program world wide
- Find corporate sponsors to help sustain the program
- Standardize screening programs
- Assist the athletes with intellectual disabilities to obtain follow up care.
Findings from Special Olympics Data by Jenkins on foot pathology in IDD
Joint Range of Motion
A reasonable diagnostic standard for defining restriction of ankle joint motion is less than 5-10 degrees with knee extended (Valmassy, 1992) but a standardized, universally accepted definition for equinus is not available (Jenkins, 2011; Frykberg, 2012). Highlighting the lack of standardization of defining equinus, Frykberg et al (2012) used an even stricter definition of equinus (ankle joint dorsiflexion less than 0 degrees) to discover that equinus may be even more prevalent in diabetic patients than previously reported. In the study by Jenkins, 21.1% (789) of screened athletes in Athens presented with restricted ankle motion compared to 33.8% (1761) of the US cohort (Jenkins, 2014). Both findings are higher than a general population sample of 1666 subjects that found a 10.3% prevalence of restricted ankle motion (Lavery, 2002). The literature suggests that 77 degrees of dorsiflexion is normal (Buell, 1988). This study identified that 8.9% (344) of the athletes in Athens presented with restricted motion in the 1st MTPJ v. 14.8%(723) in the US cohort (Jenkins et al, 2014). Restricted joint motion is an important risk factor for the development of DFUs because it does not allow for proper dispersion of forces on the bottom of the foot and can increase pressure on bony prominences on the bottom of the foot; the increased pressure leads to a callus which, if not addressed properly, can lead to a breakdown of the skin and an ulcer has formed.
(Table from: Jenkins, 2014)
(Table from: Jenkins, 2011)
Pes Planus: The Athens population was not different from the US Special Olympics population, 38.1% versus 38.5% in regards to pes planus. In a cohort of 825,964 individuals entering the military service, mild flexible pes planus occurred in 12.4% of the cohort while severe flexible pes planus occurred in 3.8%. Males had a greater prevalence of pes planus than females and pes planus was associated with increased BMI and shortness in body height (Tenenbaum, 2013). The results of this latest study concur with previous studies on pes planus with prevalence ranging from 2.9 to 17% (Gould, 1980; Spahn, 2004; Sachithanandam, 1995). Significant ligamentous laxity and connective tissue change is present in many athletes with intellectual disability, and pes planus is an anticipated finding. (Jenkins, 2014).
Hallux Abducto Valgus (HAV) [Bunion Deformity]– The Athens population had a lower prevalence than the USA Special Olympics cohort, 5.4% versus 13%, but a greater prevalence than a similarly matched general population of 2.5-3.5% (Gould, 1980; Spahn, 2004; Ferrari, 2009; Greenberg, 1994). The presence of ligamentous laxity and connective tissue changes present in many Special Olympics athletes may have contributed to the increased prevalence of this condition (Jenkins, 2014).
The rate seen in the Fit Feet athletes was 12.8% as noted in Table 5 and compared to the rate of a similarly matched general population of 0.03%-5%. Hallux abducto valgus deformity is of special concern due to the potential for shoe fitting problems (Jenkins, 2010).
(Table from: Jenkins, 2014)
6) Referral of High-Risk Individuals to Local Providers
The goal of the screening process is to identify IDD individuals at risk for diabetes and/or foot complications. One of the measures to be analyzed by survey data is whether or not the individual has an established primary care provider and a podiatrist. If the patient does not have a primary care provider, the program will assist with research of local providers and attempt to facilitate establishing primary care services. If the individual does not have a podiatrist, the program will facilitate finding a local podiatrist who can provide preventative care services.
Podiatry’s Role in Preventing DFUs in the IDD Population
A podiatrist is a limited scope physician (as defined by the Social Security Act) with expertise in the assessment and treatment of pathologies of the structures related to the foot and ankle (American Podiatric Medical Association). Prevention through regular monitoring and treatment by a podiatrist is essential in preventing the cascade of events that culminate in limb loss. There have been multiple prior published studies demonstrating the benefits of a podiatrist as part of the diabetic limb salvage team (Hedetoft, 2009; Trautner, 2007; Canavan, 2008; Lavery, 2005; Litzelman, 1993; Patout, 2000).
(Table from: Kim, 2012)
Carls et al reported in 2011 that if a podiatrist saw diabetic patients at least once in the year preceding ulceration, a commercially insured patient would realize an average cost savings of $19,686 and a Medicare-eligible patient would realize an average cost savings of $4,271 (Carls, 2011). Additionally, Sloan et al (2010) found that Medicare-eligible patients (5% sample, 189,598) with diabetes were less likely to experience lower extremity amputation if a podiatrist was a member of their health care team (Sloan, 2010).
Care of the diabetic foot involves a focused interdisciplinary team that includes the surgical subspecialty of podiatry (Sanders, 2010; Mills, 2010; Steed, 1993; Stumpio, 2010). This team approach translates to decreases in major amputation rates by >50% and overall improved outcomes for this challenging patient population (Hellingman, 2008; Aksoy, 2004; Yesil, 2009; Hedetoft, 2009). Podiatrists play an important role in the prevention and treatment of foot deformities and complications related to diabetes and high amputation risk (Robbins, 2006; Synder, 2004; Turns, 2000; Foster, 1995;). Effective prevention includes regular foot examinations, risk stratification, and appropriate shoe-gear recommendations (Rijken, 1999).
Access to podiatric services has been highlighted and understanding the barriers to care for people with IDD is an important area for investigation. Mental capacity is essential in gaining consent and enhancing adherence to management, and thus further exploration of methods to enhance mental capacity of people with IDD on foot disorders is required. Promoting good foot health among people with IDD considering the health risk they currently experience depends on podiatrist and carers recognizing foot disorders and their presentation in people with ID. In this way, mobility can be maintained or improved that would contribute to better health outcomes for people with IDD (Courtenay, 2015).
Foot problems are common form childhood to adulthood among people with IDD. Bony deformities of the foot, general health disorders, musculoskeletal disorders, and inappropriate footwear contribute to the development and aggravation of foot disorders. People with IDD generally are disadvantaged as they do not have good access to podiatric services even when foot problems are well known. People with syndromic disorders have a high prevalence of foot disorders often because of lax muscles and ligaments in the foot. To effectively manage foot disorders in people with IDD, good communication with the person is essential to help understanding and adherence to treatment plans (Courtenay, 2015).
Corn production is thought to be stimulated by trauma to the tissues in the form of mechanical stresses, which cause release of inflammatory mediators and growth factors (Springett, 1993). Foot pain and corns are also associated with poorly fitting footwear. A survey of 176 older people found that foot pain, disability and corns were more common in those wearing narrower shoes (Menz, 2005). Farndon (2015) reported that the most frequently presenting problems were corns and calluses (26%) resulting in this being the most common type of treatment performed by the profession (19%) in a typical working day.
Discussion Overview: Discuss obstacles to implementing such a program
- List of Potential Obstacles to Program Implementation
- Legislation Addressing Podiatry Coverage for Medicaid: The HELLPP Act
- The Need for more primary prevention Research/RCTs for DFUs
Potential Obstacles: 1) Logistics & 2) Budget
- What to do if patients don’t have insurance? Can they be treated at FCNY? Would they be turned away?
- Who coordinates the visits? Who is the point person? Must coordinate with group homes and figure out the logistics/legal/coordination issues
- May potentially need IRB approval to acquire research data/take surveys/take pictures of feet for the IDD population.
- Current Medicaid climate is an obstacle to proper prevention/treatment of the IDD population since they have barriers to access to medical services coverage. (See Below, The HELLPP Act)
- How much would a program like this cost to design and implement? Would there be significant start up costs or would the maintenance and development of the program be the main budget item
- Who will cover the budget costs for the program? FCNY or group organizations or both?
- What training documents will be created and by whom? Who is in charge of establishing the protocols and standards for the program?
- Will there be any perceived issues from the standpoint of the IDD individuals and group organizations? i.e. will this program be openly accepted and utilized if made available to the IDD population?
Legislation Addressing Podiatry Coverage for Medicaid: The HELLPP Act
(The following section was pulled verbatim from AMPA documents that can be found at www.APMA.org/saving) *NOTE: underlined portions added for emphasis
The Helping Ensure Life and Limb Saving Access to Podiatric Physicians (HELLPP) is a bipartisan, common-sense act that would modernize and strengthen the Medicare and Medicaid programs. The HELLPP Act aims to improve the Medicare and Medicaid health outcomes, enhance patient choices, and actually reduce the federal budget deficit. To accomplish this, the act has 3 provisions: 1) recognizing podiatrists as physicians under Medicaid, 2) Clarifying and improving coordination of care in Medicare’s Therapeutic Shoe Program for patients with diabetes, and 3) strengthening Medicaid program integrity through a fiscally responsible budget offset.
For more than 40 years, Medicare has defined doctors of podiatric medicine (DPMs, or podiatrists) as “physicians”. But this is not the case in Medicaid. Access to medical and surgical foot and ankle care provided by a podiatrist is considered optional and is not covered by all state plans, thus limiting Medicaid patient access to specialized foot and ankle medical and surgical care. The HELLPP Act would bring Medicaid in line with Medicare (and a majority of US health-care delivery systems) and ensure Medicaid patients have access to care by the best educated and trained providers of foot and ankle care. The legislation would not mandate new Medicaid services or benefits, nor would it require any Medicaid patient to seek care from a podiatric physician. It would not expand the scope of practice, it would simply provide that Medicaid patients have a full range of choices to see the physicians who are best trained for the foot and ankle care they seek. Evidence shows that when podiatrists are delivering foot and ankle care, outcomes are better, hospitalizations are fewer and shorter, and the healthcare system saves billions of dollars annually. Podiatric physicians and surgeons are often included in prominent public and private benefits packages. Under current law, foot and ankle care services are a covered benefit. However, when those services are provided by podiatrists, they can be teased out as “optional” coverage (“podiatry services”). This problem persists because podiatrists are not defined as “physicians” under Medicaid even though they have been defined as such under Medicare for more than 40 years. Currently, Medicaid effectively discriminates and can arbitrarily preclude patient access to a licensed and credentialed specialized physician class even though the services provided are a covered benefit. Thus, Medicaid fails the basic tests of free market competition and patient choice.
Another proposal of the HELLPP Act is to strengthen Medicaid program integrity through fiscally responsible budget offset. By closing a loophole that allows tax-delinquent Medicaid providers to still receive full Medicaid reimbursements, this provision will save the Medicaid system money and more than offset any additional federal budget costs associated with the recognition of podiatrists as physicians under Medicaid. Such a mechanism already exists in Medicare so this could save billions of dollars for the public healthcare system. Under current law, Medicaid healthcare providers who owe significant back taxes are still getting paid in full by Medicaid because of a loophole in the tax laws. The Government Accountability Office (GAO) conducted a study highlighting this irregularity, released July, 2012 (GAO-12-857): “Providers in Three States with Unpaid Federal Taxes Received over $6 Billion in Medicaid Reimbursements.” GAO estimates that the government could have recouped up to $330 million in uncollected taxes due in 2009 in three states alone if the legal mechanisms were in place for Medicaid the way they are in Medicare to offset public program payments for federal taxes owed.
Whenever public or private health insurance programs preclude patient access to podiatric physicians, there are adverse impacts on the healthcare system including: 1) costs increase by driving patients to a more expensive point of service (e.g. hospital emergency rooms) for the same services, 2) it exacerbates America’s growing physician shortage by not appropriately utilizing the full range of physician specialists, and 3) it denies patients the option of seeing the physicians who are best trained for the foot and ankle care they seek.
An example the unintended consequences of denying patient’s access to podiatrists can be seen in the “Arizona Medicaid Study: Exclusion of Podiatric Physicians and Surgeons Adversely Impacted Diabetic Patient Health and Program Finances” (Skrepnek, 2014; Source: APMA) In 2009, Arizona decided to remove Medicaid patient access to DPMs, which lead to a “marked worsening of outcomes and cost for patients with diabetic foot infections” (73rd Scientific Sessions –ADA, 2013). The study concluded that each $1 of Medicaid program “savings” the state anticipated from the elimination of podiatric medical and surgical services, actually increased costs of care by $48. The study found a significant decline in quality outcomes and higher program expenditures among those with diabetic foot infection, including: 37.5% increase in diabetic foot infection hospital admissions, 28.9% longer lengths of in-patient hospital stays, 45.2% higher charges, and a nearly 50% increase in severe aggregate outcomes (i.e. death, amputation, sepsis, or surgical complications).
Arizona’s Medicaid experience underscores the compelling policy rationale for removing patient access barriers to podiatric physicians and surgeons. The Arizona study complements two additional, separate studies that found that when podiatrists are administering medical and surgical foot and ankle care, outcomes are better, hospitalizations are fewer and shorter, and the health-care system saves billions of dollars annually (APMA, 2011). The core problem persists because podiatrists are not defined as “physicians” under Medicaid, even though they have been defined as such under Medicare for more than 40 years and are recognized as such throughout most of the US healthcare system. Ironically, Medicaid only ensures coverage of necessary foot and ankle care if provided by a medical doctor (MD) or Doctor of Osteopathy (DO). But Medicaid coverage for foot and ankle care provided by DPMs is optional for states, meaning “podiatry services” are teased out and classified as an “optional” benefit. Under current law, states are under constant pressures to curtail “optional services” like patient access to podiatrists in a “penny wise/pound foolish” attempt to trim Medicaid budgets. But as the Arizona Medicaid study indicates, doing away with “podiatry services” is a classic demonstration of the law of unintended consequences.
Unnecessary higher Medicaid spending by states also translates to unnecessarily higher spending by the federal government, because Medicaid is financed jointly by the federal government and the states. The federal government matches state Medicaid spending. As Arizona Medicaid has shown, maintaining a separate optional podiatry benefit has had significant negative health effects on patients with diabetes. State (and by extension, federal) Medicaid spending is not reduced, but merely redistributed to another setting or provider, often with adverse consequences for patient health and health costs. The current ever-changing patchwork of Medicaid patient access has the effect of limiting access to timely and appropriate foot and ankle care, at a time when the US is already facing a growing physician shortage. So long as our public policy focus is on the type of provider rendering foot and ankle care, instead of ensuring the coverage of medically necessary foot and ankle care, preventable chronic conditions will become an even greater cost burden for Medicaid. In virtually all other healthcare settings – Medicare, private employer coverage, Federal Employees Health Benefits (FEHBP), TRICARE, the Veterans Administration, and the Indian Health Service – patient access to specialized medical and surgical care is ensured. Medicaid is the glaring exception.
The Need for more primary prevention Research/RCTs for DFUs
The International Working Group on the Diabetic Foot (IWGDF) made a number of recommendations in 2016 on footwear and offloading interventions aimed at preventing ulceration or promoting healing (Bus, 2016). With the exception of surgical recommendations, all of the suggested approaches require the individual to engage with treatments they may be unable or unwilling to tolerate. Furthermore, it is of interest that nine out of 13 recommendations were based on low-quality evidence, with only one (offloading with a non-removable device) being derived from high-quality evidence. This juxtaposition of potentially unwelcome behavioral demands, advocated on the basis of a weak evidence base, leads to people reporting low knowledge of, and exhibiting poor adherence with, foot care behaviors (Gale, 2008; Waaijman, 2013).
First, the role of primary prevention needs to be clarified. Few randomized trials have examined the impact of primary prevention efforts. Larger, better quality trials may be needed to more convincingly demonstrate the benefit of various forms of primary prevention (Barshes, 2013). Recurrence of DFU is frequent, and better methods for reducing this recurrence rate are needed (Armstrong, 2013).
Next, there exists a large gap between the impact of DFUs and funding for research to improve management. Of more than 22,000 diabetes related research projects with US federal funding between 2002 and 2011, only 33 (0.15%) were related to DFU care. Although diabetic foot complications may comprise as much as 30% of excess medical costs of patients with diabetes (ADA, 2013), the cumulative funding for these projects accounted for only 0.17% of the total US funding for diabetes-related research, a >600-fold difference (Armstrong, 2013)
Additionally, of the 100 most recently published randomized controlled trials (RCTs) on the diabetic foot listed in PubMed as of 12 April 2015 (search terms ‘Diabetic foot’ and ‘RCT’), 62 are on ulcer healing and only six on ulcer prevention(van Netten, 2015). So, for every RCT on prevention, ten are conducted on healing. Also, within the research topic of ulcer prevention, a clear disparity is present: only three of the 30 controlled studies identified in the 2015 IWGDF systematic review on ulcer prevention focus specifically on a first foot ulcer (van Netten et al, 2015). This dominance of studies on recurrence may exist because (1) patients with ulcer history are at greatest ulcer risk, which increases the relevance to study these patients, and (2) trials on ulcer recurrence require fewer patients to demonstrate efficacy given the higher expected event rate (Bus & van Netten, 2016).
The lack of expenditure for diabetic foot ulcer prevention is not isolated to the United States. In Europe, the costs incurred for treatment far outpaced those for prevention of DFUs. For example, for every euro spent on prevention, ten are spent on ulcer management (van Acker, 2000; Kerr, 2014). If one million patients with diabetes is considered, and an annual 2.2% ulcer incidence rate (Abbott, 2002), total annual treatment costs of foot ulcers are 220 million euros. However, if 50% of ulcers can be prevented with proper preventative care (an average effect size shown in 30 controlled studies on prevention) (van Netten, 2015), costs for the same population of patients can be reduced to 110 million euros, a difference in saving of 88 million euros per million persons with diabetes.
Recent data suggest that only a small proportion of diabetes-related research funding goes into psychosocial studies (Jones, 2016). This is despite the psychological burden of people with foot disease being larger than in the population without diabetes, or in those with diabetes, but without diabetic foot ulcers (Clokie, 2016). A cost-utility simulation based on Markov modeling showed that intensified preventative care would be cost-effective in at-risk patients if a 25% reduction in foot ulcer incidence is achieved (Ragnarson & Apelqvist, 2001).
Conclusion Overview: The program plan detailed in the paper is intended to have an impact on public health and podiatry by addressing the diabetes epidemic. The theoretical framework laid out above can be adapted and modified to different settings. The conclusion section addresses the estimated timeline for program implementation at the New York College of Podiatric Medicine and the plan for program evaluation.
- Timeline for Program Implementation
- Plan for Program Evaluation
Timeline for Program Implementation
January 2017 – January 2018:
- Design and edit Program Plan
- Develop detailed implementation and evaluation plan
January 2018-May 2018:
- Develop and design training materials to be used for foot screening
- Train first batch of podiatry students to perform foot screenings and collect data and survey.
- Begin outreach and search for subjects for program (ie identify cohort).
- Implement Bristol Foot Score in cohort to assess perceived foot care needs
- Outreach for locations and organize logistics for implementing foot screenings for IDD population.
- Pilot program testing data collection process
June 2018-December 2018:
- Analyze screening data to use for risk assessment
- Compile analysis of data into article detailing prevalence of podiatry conditions in IDD cohort
- Continually assess perceived foot health needs via Bristol Foot Score and augment program education and processes to reflect current needs
- Implement targeted education and preventative foot health care to IDD population
Plan for Program Implementation
- Foot Screening Data: The plan is to evaluate demographic and objective data and compile prevalence rates of podiatry conditions in an IDD cohort and compare to research by Jenkins to add to the knowledge base of IDD podiatry conditions.
- Bristol Foot Score Data: The data willb eused to evaluate the perceived patient-centered foot needs of the IDD population. Once perceived needs are established, targeted education and intervention can be planned and implemented to specifically address these needs. For example, if an individual has a perceived need of difficulty finding shoes that fit pain-free, then targeted education about how to find accommodative shoes and demonstrations on how to troubleshoot shoe fitting can be implemented.
Relevant Definitions, Classifications, and Descriptions
Source: International Working Group on the Diabetic Foot (IWGDF)
- Diabetic foot: Infection, ulceration, or destruction of tissues of the foot associated with neuropathy and/or peripheral artery disease in the lower extremity of people with diabetes
- Diabetic Neuropathy: The presence of symptoms or signs of peripheral nerve dysfunction in people with diabetes, after exclusion of other causes.
-Loss of protective sensation: Inability to sense light pressure, e.g. as applied with a 10 gram Semmes-Weinstein monofilament
- Peripheral Artery Disease (PAD): Obstructive atherosclerotic vascular disease with clinical symptoms, signs, or abnormalities on non-invasive vascular assessment, resulting in disturbed or impaired circulation in one or more extremities.
-Foot Lesion: Any abnormality associated with damage to the skin, nails or deep tissues of the foot.
- Foot ulcer: Full thickness lesion of the skin of the foot.
- Superficial Ulcer: Full thickness lesion of the skin not penetrating any structure deeper than the dermis
- Deep ulcer: Full thickness lesion of the skin penetrating below the dermis to subcutaneous structures, such as fascia, muscle, tendon, or bone.
-Callus: hyperkeratosis (i.e. build up of skin) caused by excessive mechanical loading
- Debridement: Removal of callus or dead tissue
-Foot deformity: structural abnormalities of the foot such as hammer toes, mallet toes, claw toes, hallux valgus, prominent metatarsal heads, residuals of neuro-osteoarthropathy, amputations or other foot surgery.
-Neuro-osteoarthropathy (Charcot foot): non-infectious destruction of bone and joint associated with neuropathy.
IWGDF Risk Classification:
0 – no peripheral neuropathy
1 – Peripheral neuropathy
2 – peripheral neuropathy with peripheral arterial disease and/or a foot deformity
3 – peripheral neuropathy and a history of foot ulcer or lower-extremity amputation
- High risk: presence of characteristics indicating a greatly increased probability of developing a specific condition or an event.
- Low risk: a low probability of developing a specific condition or event.
A Copy of the Bristol Foot Score:
All references are in Chicago style. Citations within the text above list only the first primary author and the date of publication.
*Please disregard inconsistencies in formatting; all citations were generated using Google Scholar and some citations have different formats even though all are in “Chicago Style”.
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