Abstract
Detection of diabetic foot complications is key to amputation prevention. This study used survey and retrospective record review to examine the relationship between frequency and performance of clinician’s diabetic foot examinations on performance of patient home self-foot examinations. An additional aim was to assess clinician performance of annual foot examination per American Diabetes Association (ADA) guidelines in a specialty clinic. The relationships between demographic characteristics, diabetic foot ulcer beliefs, health literacy, HbA1c level, and foot self-exam performance was also examined. No relationship was found between the performance frequency of foot examinations by providers and patient self-examination (N = 88). The presence of specific barriers to self-management was significantly higher in those patients who did not complete daily home self-foot examinations. Only 16% of patients’ charts reviewed met the ADA criteria for a complete annual foot exam. Motivational interviewing during patient visits could be a strategy to break down barriers to self-foot exam performance. Furthermore, the development of an Electronic Medical Record (EMR)–based diabetic foot exam template to improve provider documentation may improve compliance with ADA recommendations.
Worldwide, there are approximately 382 million adults with diabetes, and this number is expected to increase to 592 million by 2035 (Diabetes in the UK, 2014). Complications of diabetes “are common, complex, and costly, mandating aggressive and proactive preventative assessments by generalists and specialists” (Boulton et al., 2008, p. 1683). People with diabetes have up to a 25% lifetime risk of developing a foot ulcer and diabetes is the leading cause of foot amputations (Centers for Disease Control and Prevention [CDC], 2011). Foot ulcers and amputations are a significant driver of costs of care, and interventions that target reduction in their numbers are important to not only reduce costs but also improve patient health related quality of life.
Comprehensive foot care programs that include risk assessment, foot care education and preventive therapy, treatment, and referral to specialists can reduce rates of amputation by 45% to 85% (CDC, 2011). In light of this, the American Diabetes Association (ADA; 2013) recommends that a minimum of one complete foot examination be performed by a health care provider annually on patients with diabetes to identify risk factors predictive of ulcers. Although the ADA recommends annual foot exams, research supporting the basis for this timing is lacking. It is currently unknown whether the frequency and quality of foot examinations provided by clinicians has an effect on the frequency and performance of patient’s home self-foot examinations. From a patient education standpoint, providing a single foot examination per year may be insufficient to have an effect on patient’s knowledge and frequency of their home foot care practices (part of a comprehensive foot care program). With diabetes-related foot ulcers and amputations being such a big part of cost of care, prevention and risk minimization are important. The performance of foot exams by both providers and patients play a major role in risk reduction.
Although research is lacking associating the frequency of provider foot examinations to home foot examination compliance, there are studies looking at provider evaluation and foot exam compliance. In a study by Bundesmann and Kaplowitz (2011), a phone survey asked 1,438 respondents with diabetes about their self-care activities after provider appointments. The results showed health care providers who included education in their treatment plan more than doubled the chance of patients self-reporting the performance of home foot examinations. Memorable provider communication with the patient was noted to be the key to increased compliance with health promotion activities. As provider foot examinations are an opportune time to interact and teach patients about self-foot care, there may be a connection between the frequency of provider foot examinations and patient’s foot care education.
Chin, Huang, and Hsu (2013) examined modifiable social-psychological factors that could affect daily foot exams. Their cross-sectional survey of 277 patients collected data on foot exam practice, perceived self-efficacy, and action cues. The results showed select action cues (recommendations from family, friends, or health professionals) influenced the patient’s practice of daily foot examinations. Furthermore, perceived self-efficacy and perceived barriers significantly influenced the patient’s daily foot exam practices.
Finally, Furthauer, Flamm, and Sonnichsen (2013) interviewed patients and providers regarding factors affecting deviation from guideline recommendations on a multitude of chronic diseases including diabetes. Although this study did not include foot examinations, it speaks to the overall statistics of provider adherence to guidelines. In regard to diabetes guidelines, adherence referred to prescribing Metformin to patients with type 2 diabetes with Hba1c levels of 7% or greater. Overall, providers were not adherent to clinical guidelines 16.8% of the time (Furthauer et al., 2013). The majority of providers who failed to implement guidelines were either unfamiliar with the guidelines or were not aware they existed. As communication during provider foot examinations plays an important role in patient education, straying from the fundamentals and schedule recommended by the ADA guidelines may have an undesirable impact on patient’s daily home foot care practices. For this reason, its critical providers are current on clinical guidelines, which may affect patient knowledge and performance of home foot care practices.
Purpose of Study
Presently, there is evidence to support comprehensive foot care programs for reduction in amputation rates and professional organizations creating clinical guidelines/quality measures. However, there is no evidence connecting the association between frequency of provider examinations to patient’s performance on self-foot examinations or to frequency of self-foot examinations. The goal of this project was to answer the following questions: (a) What are the relationships between demographic characteristics, diabetic foot ulcer beliefs, health literacy, HbA1c level and home foot exam performance? (b) Does the frequency of foot exam by providers enhance the patient’s awareness of the need to do and performance of self-foot exams? (c) Considering diabetes specialists should be familiar with ADA standards regarding foot examinations, how well does a specialty diabetes clinic meet established standards for annual complete foot examinations?
Design and Method
A cross-sectional survey design along with retrospective chart review was used to meet study aims. The study underwent institutional review board approval and all participants provided written informed consent prior to participation.
The setting was an urban diabetes care clinic (DCC) in Seattle, WA, which has a volume of approximately 700 patient visits per month from a total patient caseload of more than 2,500 individuals. A convenience sample of DCC patients meeting eligibility criteria (n = 100) was recruited on non-sequential clinic days from the waiting room/lobby between January 2014 and April 2014. There was a break in recruitment during this period due to the DCC moving to a new location. Inclusion criteria were as follows: (a) Participant must present to the DCC for care, (b) be at least 18 years old, and (c) and have a confirmed diagnosis of type 1 or 2 diabetes. Exclusion criteria were (a) if the visit was the patient’s first visit to the DCC and (b) if the patient was not fluent in written English.
Potential subjects were approached in the waiting area/lobby of the DCC and asked to participate in the study. Following informed consent, participants completed the survey prior to provider visit, to minimize bias. Participants were informed their individual responses would be kept confidential and not be shared with their provider. Two different information collection methods were used to record data during this study. First, patients filled out a paper-and-pencil survey to gather data regarding demographics (age, gender, education) and knowledge of foot exam performance, to include barriers and facilitators. The survey took 5 to 10 min to complete. Second, chart review was performed to extract data on the performance of provider administered diabetic foot examinations as well as most recent HbA1c level. Data collected included frequency and components of the exam. Data were extracted from the medical record following the clinic visit.
Instruments
Diabetic Foot Ulcer Health Belief Scale
The instrument used for this study was a localized version of the scale developed and validated by Chin et al. (2013). The scale was independently translated from Taiwanese to English by two (1 Chinese, 1 Taiwanese) School of Nursing PhD students. The translated survey was reviewed for validity by a certified diabetes educator/family nurse practitioner at the DCC. The survey consisted of 37 questions: health literacy (3), perceived barriers (13), threats (9), and benefits (12). A Likert-type scale of 1 to 5 (1 = strongly disagree, 5 = strongly agree) was used. Five questions in barriers used a reversed Likert-type scale (1 = strongly agree, 5 = strongly disagree) but were converted back during analysis.
Medical record review
After the survey was conducted, the participant’s medical record was used to retrospectively examine DCC visits for the past 3 years. We extracted data from visits to measure frequency of in-office foot exam and component completion rates. We used these data as the independent variable to assess outcomes of knowledge, attitudes, and performance of foot exams. We also examined whether the clinic was compliant with ADA foot exam guidelines. Annual diabetic foot examination criteria was based on the ADA (2013) guidelines: (a) Inspection, (b) Assessment of foot pulses, and (c) Testing for loss of protective sensation (LOPS; 10-g Monofilament plus testing any one of the following: vibration using 128-Hz, tuning fork, pinprick sensation, ankle reflexes, vibration perception threshold). Visits where a foot exam was performed by the provider were either classified as (a) complete foot examination per ADA guidelines or (b) incomplete foot examination. ADA complete foot examinations were determined when all elements of ADA guidelines were correctly recorded in the patient’s medical record. Providers were given credit for an incomplete foot examination when part, but not all exam elements were recorded in the patient’s medical records.
Data Analysis
Data from the survey and medical record review were entered into Microsoft Excel and SPSS version 20 for analysis. Participants were classified based on self-report as either completing daily foot exams or not performing daily foot exams. This classification was used to examine group differences in demographics, health literacy, survey sub-scales and provider completed foot exams. Analysis included descriptive statistics, t tests, chi-square, logistic regression, and Pearson’s correlations. Analyses were considered significant if p value was <.05.
Findings
One hundred participants were enrolled. However, 12 participants had to be excluded, leaving 88 participants for analysis. Reasons for exclusion included incomplete informed consent form, incomplete survey, or the patient was not found in the Electronic Medical Record (EMR).
The number of male and female participants was relatively similar, with 53.4% of the sample being male. Patients averaged 3 visits per year to the DCC with a range from 0 to 19. Furthermore, the mean patient HbA1c level was 8.1% (SD = 2.06). The education level of this sample was high, with all participants having at least a high school degree and 88% having some college or greater. Only 29.5% of participants reported performing daily self-exam. Demographics by self-reported patient foot exam performance are displayed in Table 1; there was no difference in any characteristic between the two groups. The sample also had a high degree of health literacy (see Table 2); again, there were no between-group differences in daily versus non-daily performers.
Demographics of Sample Data Are Presented as n (%) Unless Otherwise Noted.
Health Literacy of Sample by Foot Exam Performance.
Note. There were no significant differences between the two groups.
In comparing participants who reported performing daily foot exams and those who performed less than daily foot exams, there were no significant differences in responses to survey items indicating perceptions of benefit or threat influencing performance (Table 3). However, there were significant differences between the two groups on perceived barrier items as a whole (Table 3) and individual items. Items perceived as barriers for non-performers were as follows: (a) being too busy (p = .001), (b) perceiving foot exams as being too much trouble (p < .0005), and (c) perception of foot exams as not important (p = .015). Surprisingly, logistic regression analysis examining the association between outcome of patient performance of daily foot examination and predictor values of (a) number of complete ADA foot exams by provider and (b) total foot exams by provider found no relationship. Similarly, no relationship was found between higher levels of patient awareness of the need to do the exam and number of provider exams.
Diabetic Foot Ulcer Health Belief Scale Results Compared by Daily Foot Self-Exam Performance (Disagree = lower score; agree = higher score).
Review of the medical records showed that while 71% of patients received a foot exam at every visit, only 13% met the criteria for a complete exam per ADA guidelines. In addition, just 16% of the sample met ADA criteria for a complete foot exam by a DCC provider annually. In examining performance of the exam components, the items most often missing were the 10-g monofilament and a second neurological exam (35% and 27% performance, respectively; see Figure 1). Interestingly, there was a significant association (p = .02) between A1C levels and ADA complete foot examinations by the provider; however, the R value (.24) indicated only a weak correlation.
Breakdown of foot exam components completed.
Discussion
Based on literature suggesting a relationship between action cues, such as the frequency and performance of provider foot examination (Chin et al., 2013), and the frequency and performance of patient home self-foot examinations, we were surprised to find no connection in the present study. There were significantly fewer perceived barriers to self-exam performance between participants who performed daily exams compared to those who performed exams less than daily. This is similar to the findings of Chin and colleagues (2013). With a sample having a minimum of at least a high school education and high self-reported health literacy, the fact they understood benefits of the exam is not surprising. However, simply understanding the benefits behind foot examinations did not lead to better performance rates of home foot examinations. Barriers such as being too busy, foot examinations being too much trouble, and exams not being important appeared to be the main factors driving non-compliance. Perhaps with motivational interviewing, the understanding of barriers with a focus on their importance, and why perceived to be too much trouble could lead to increased numbers of persons performing exams daily (Tinloy, Kaul, Ulbrecht, Schaefer, & Gabbay, 2014).
Medical record data showing 71% of patients visiting the DCC receiving a foot exam is an encouraging start. However, as only 16% of patients received a complete annual foot exam, we expected higher benchmarks performance from the diabetes specialty clinic. The most common reasons for an exam being deemed incomplete were either a missing 10-g monofilament or non-completion of a second neurologic examination. It is important to note the reason behind adding a second neurological examination to the monofilament exam is that it increases the sensitivity and diagnosis of diabetic peripheral neuropathy to 87% (ADA, 2013). Looking at actual documentation written for the visits, details from the foot exam were frequently vague. Occasionally, some providers documented as little as “feet look good” or “feet normal” into the inspection section of the medical record. However, some providers chose to use a checklist, and these exams anecdotally were the most complete. As a next step, integrating the checklist into the EMR system may be a relatively easy way to increase compliance with guidelines.
Limitations to this study include review of patient records from one chosen specialty clinic, which may have led an unrepresented cross-sectional depiction of patient’s in-office foot examinations by other providers such as family practice and podiatry. Some patients during the study revealed their feet were examined by podiatry on a monthly basis due to poor condition of their feet. It is certainly possible that foot examinations by these providers could account for the relationship between the frequency and performance of patient’s self-foot examinations. Furthermore, some patients with significant feet morbidity revealed they sometimes decline provider foot examinations at the specialty clinic, because they were so frequently monitored by podiatry. As the study saw only one instance where patient refusal was documented, we believe the actual number may be significantly under-represented. This represents an important reason why providers should document patient declination of foot examination as opposed to leaving the exam blank in the chart note. It would also be rational to consider patients with frequent feet monitoring by providers outside this study believe it is less important for them to check their own feet. This may be due to a sense of false security felt by frequent routine monitoring by trusted health care providers and account for some of the non-daily foot exam patients believing self-foot exams are not important. However, the study was not designed to provide evidence to support this hypothesis. This discrepancy may be elucidated by further interview of patients about these aspects of care and data collection regarding the presence and degree of foot ulceration.
Another limitation of the study was that we did not differentiate between patients with type 1 or type 2 diabetes. It is certainly possible that there are differences between these two groups with regard to self-management behaviors, as development of type 2 diabetes is often associated with unhealthy lifestyle choices.
Application
Based on the results of this study, we crafted a few recommendations to help improve both provider and patient performance on foot examinations. Accordingly, an emphasis during patient visits can break down perceived barriers to self-foot exam performance. In particular, motivational interviewing could be an effective strategy as it focuses on overcoming ambivalence (too busy, not important) and identifying barriers (too much trouble). The performance and documentation of all components of the annual foot exam by DCC providers is an area that can be improved. This is especially true for assessing LOPS. Adding a checklist to the EMR as a macro covering each of the ADA foot exam components may help with increasing compliance with published guidelines. Furthermore, providers may wish to review the specific components (e.g., neuro) of the ADA foot exam, and educate patients who decline foot examinations on why foot examinations are important.
As there are limitations to our study that must be considered, providers should not conclude provider foot examinations do not affect the frequency and performance of patient home self-foot examinations. We were limited by a single EMR system that did not cover all provider visits. Future studies which include all provider visits (DCC, primary care, podiatry, etc.) by patients are needed to prove or disprove this hypothesis. This would also support meaningful use through measurement and reporting of clinical quality measures of diabetes care.
Footnotes
Acknowledgements
The authors acknowledge Phyllis Christianson, MN, RN, GNP, and Joanne Whitney, PhD, RN, CWN, for constructive feedback regarding this work.
Authors’ Note
Jesse Pocuis and Sam Man-Hoi Li contributed equally to this work.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.