November 2018

The PodPAD Project: A Podiatry-led Integrated Pathway for People with Peripheral Arterial Disease in the UK – a Pilot Study

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Clinical evidence suggests that this intervention (foot care plus advice on diet, exercise & smoking) is highly effective at reducing the progression into acute care and can reduce the incidence of amputation by 60%.

By Lisa Farndon, John Stephenson, Oliver Binns-Hall, Kayleigh Knight, and Sally Fowler-Davis

Peripheral Arterial Disease (PAD) is a long-term condition characterized by atherosclerotic obstruction of the lower extremity arteries and is a marker of patients who are at increased risk of cardiovascular events, including myocardial infarction and stroke. The incidence in the over-60s is approximately 20% and increasing with age and other factors, including: smoking, diabetes and existing coronary arterial disease. In the lower limb, PAD may be symptomatic with intermittent claudication or asymptomatic and can lead to foot ulceration and critical limb ischemia, all of which can result in amputation. Heavy smokers are four times more likely to develop intermittent claudication compared to non-smokers. Intermittent claudication is also associated with reduced quality of life and depression.

As clinicians of the lower limb, podiatrists are able to assess patients for signs of PAD, offering treatment, surveillance, advice and follow-on referral to the vascular surgery team if needed. The clinical evidence base suggests that this intervention (foot care and advice on diet, exercise and smoking) is highly effective at reducing the progression into acute care and can reduce the incidence of amputation by 60%. Strict pharmacological management of cardiovascular risks specifically in people with diabetes and foot ulceration has been shown to reduce mortality rates. It is recommended that all providers have a clear plan for patients suspected of PAD.

Treatment

Early identification of both asymptomatic and symptomatic PAD allows for early intervention, slowing disease progression and decreasing the risk of lower limb amputation and cardiovascular morbidity and mortality. The overall aim is to sustain or improve mobility and quality of life. Key areas to the management of symptoms include smoking cessation, weight management and increased activity. Regular exercise can reduce cardiovascular mortality by 50% and is an effective treatment for PAD. Other treatments include lipid modification and statin therapy, the prevention and management of diabetes (if applicable), management of high blood pressure (if applicable), and antiplatelet therapy (if required). If conservative treatments are not effective, patients can develop more severe PAD where a surgical intervention in the form of angioplasty or bypass graft may be required. The aim of this study was to investigate the feasibility of a podiatry-led integrated care pathway in the UK, utilizing advice on diet, activity and smoking cessation for people with PAD and measuring the clinical and patient centered outcomes.

Methods

The study was located at a UK National Center for Sports and Exercise Medicine, in which health care clinics are situated in existing leisure/sports facilities. This allowed easy access to gym facilities for participants, if they agreed to this as part of their activity program. Outcomes considered to be favorable were: improvement in symptoms of PAD (reduction in intermittent claudication pain if present), improved ankle brachial pressure index (ABPI) readings, increase in number of pedal pulses palpated or a change in Doppler sounds from monophasic to bi- or tri-phasic, decrease in cholesterol and HbA1c levels (if applicable), and the success of any smoking cessation and activity programs. Quality of life and patient satisfaction with the program were also assessed. Patients were excluded if they were unable to give informed consent due to lack of mental capacity and if they were unable to participate in increased activity due to other co-morbidities.

Inclusion criteria: Patients who were on the podiatry service PAD caseload were purposively sampled to take part in this pilot study. Anyone wishing to take part was given an information sheet, and an appointment was arranged for a baseline assessment.

Exclusion criteria: Housebound patients, patients who had poor mobility and would be unable to take part in any activity program and patients who were not able to give informed consent.

At baseline, medical history was recorded, with any symptoms associated with PAD assessed using the Edinburgh Intermittent Claudication Questionnaire, and absence or presence of lower limb pulses on palpation, tri-, bi- or mono-phasic lower limb pulse sounds with a Doppler and ABPIs assessed with a Doppler Ability System®. The EQ-5D questionnaire was given to each participant to complete to assess quality of life. Clinical measurements were taken by experienced research podiatrists with training in vascular assessment. Based on this assessment, the research podiatrists tailored a treatment plan, which included advice about smoking cessation and local support services to support smoking cessation and weight loss (if applicable), and recommendation to the physical activity referral scheme; participants were also given the opportunity to meet with a dietitian who was present in an adjoining clinic room to get advice about nutrition and weight loss (again, if applicable).

Data collection

Several outcome measures were recorded for each participant at three time points: baseline, 3 months, and 6 months. Changes from baseline to 6 months were considered to be the primary comparisons of interest.

Peripheral arterial disease

Symptoms of PAD were assessed by means of the Edinburgh Intermittent Claudication Questionnaire (EICQ). This questionnaire comprised 5 questions, all of which could be answered with a “yes” or “no.” The first question was the following screening question:

Do you get pain or discomfort in your legs when you walk?

If participants answered “yes” to this question, they were then requested to answer the following further 4 questions:

  1. Does the pain ever begin when you are standing still or sitting?
  2. Do you get this pain if you walk uphill or when you hurry?
  3. Do you get this pain when you walk at an ordinary pace on the level?
  4. Does the pain disappear when you rest for less than 10 min?

The respective responses Yes, No, Yes, Yes, Yes were taken as likely indicators of the presence of intermittent claudication (IC). A score was derived for each participant with 1 point being awarded for each instance of a response corresponding to a likely indicator of the presence of IC due to PAD (excluding presence of IC due to causes other than PAD, such as spinal stenosis). Hence, scores could range from 0 (no IC; given to those who answered “no” to the first question) to 5 (highly likely presence of IC) per participant.

Pulse measurements

Left and right posterior tibial, anterior tibial, dorsalis pedis and popliteal pulse measurements were obtained from participants at each time point, amounting to 8 measurements in total per visit. A score was derived for each participant, with 1 point being awarded for each palpable pulse reading; scores could range from 0 (indicating no pulses were palpable) to 8 (all pulses were palpable).

Doppler readings

Doppler sound readings were also taken of left and right lower limb pulses from all participants at each time point, amounting to 8 measurements in total. Sound readings were classified as triphasic, biphasic, or monophasic, with triphasic considered to be the optimum status.

HbA1c and cholesterol

Glycated hemoglobin (HbA1c) and cholesterol readings (if applicable) were recorded from the electronic patient record as near to each appointment time point as possible if these were available.

ABPI readings

Left and right ABPI readings were obtained from each participant at each time point using the Doppler ability. Overall values were calculated for each participant for each time point. Values < 0.9 are an indication of PAD, with lower values indicating greater severity of disease.

Quality of life and patient satisfaction

The EQ-5D was administered to participants at each appointment. This instrument consists of 5 questions relating to mobility, self-care, usual

activities, pain/discomfort, and anxiety/depression. All questions were 5-point Likert-style items, with a score of 1 representing no problems, and 5 representing extreme problems. Additionally, participants rated their overall quality of life on a 10-point visual analogue scale (VAS), with higher scores representing higher quality of life. A simple satisfaction questionnaire consisting of 5 questions with a free text section at the end was administered at the 6-month appointment.

Results

Data was collected on 21 individuals: 15 men (71.4%) and 6 women (28.6%). At baseline, 4 participants (19.0%) reported themselves to be smokers; 17 participants (81.0%) were non-smokers; of these, 9 were ex-smokers and 8 had never smoked.

Participants also reported a number of co-morbidities at baseline; 9 (42.9%) had hypertension; 15 (71.4%) had diabetes; 4 (19.0%) had hyperlipidemia; 4 (19.0%) had kidney disease; 3 (14.3%) had a previous stroke or transient ischemic attack; 4 (19.0%) had ischemic heart disease (IHD); and 5 (23.8%) had a previous myocardial infarction (MI).

Eleven participants were referred onto the exercise referral service; 16 participants saw the dietitian for nutritional advice at baseline and had one-to-one or telephone follow-up at 3 months. Five out of 14 participants had reduced scores from baseline of intermittent claudication during the study period. No evidence for substantive changes in Doppler sounds or ABPI measurements was revealed. Quality of life scores with the EQ-5D improved in 15 participants; this was statistically significant (p=0.007) with 14 participants who completed the simple satisfaction questionnaire expressing a positive view of the program. Of the 4 people who were smokers, 2 stopped smoking cigarettes and moved to e-cigarettes as part of smoking cessation advice. Seven participants had painful neuropathic symptoms at baseline and were referred either to their GP or to the painful neuropathy clinic for a medication review or further management options. Data for the key outcomes are presented in the figures (page 52).

Qualitative responses

Fourteen patients completed a simple patient satisfaction questionnaire, all of whom responded that they felt they could discuss their symptoms of PAD with the podiatrist, they felt involved with the treatment plan, they were satisfied with the service and they would recommend this service to a friend. When asked to rate their PAD symptoms after completing the program, 9 respondents felt that their symptoms were better and the remaining 5 said that they had remained the same.

Discussion

Though this was a small pilot study, some substantive, and in some cases, statistically significant improvements with respect to many measures have been observed over the 6-month study period. The extent of intermittent claudication in those participants with these symptoms (as assessed by the EICQ tool), substantively decreased, with the proportion of respondents reporting pain or discomfort when walking also decreasing. The proportion of patients providing tri-phasic Doppler sound readings increased slightly within the context of a small overall trend primarily between baseline and 3 months, with little further change beyond 3 months until the end of the study period. No substantive changes in ABPI between baseline and 6 months post baseline in either leg were revealed.

A substantive and significant reduction was recorded in HbA1c levels, but no changes were observed in cholesterol levels. A significant improvement was recorded in quality of life with improvements in pain scores being mainly responsible for the overall improvement as measured by the quality of life instrument.

Previous studies have shown that patients with PAD have a much-reduced level of physical activity, which can be attributed to the pain associated with the disease. However, if patients are persuaded to exercise or increase their activity levels, this can help with the symptoms and progression of the disease, and on-going compliance can be improved. A large systematic review comparing supervised exercise with usual care for claudication found that exercise resulted in more functional benefits and should be advised as part of a treatment program for people with PAD. A randomized controlled trial comparing medical care alone, medical care plus supervised exercise and medical care plus stent revascularization for aortoiliac PAD found that both exercise and revascularization resulted in improved clinical outcomes and quality of life up to 18 months later. Rather than a prescribed exercise program, our study referred participants who agreed to the exercise referral service where tailored one-to-one advice was given to increase activity levels. This was provided on site in a National Centre for Sports and Exercise Medicine, which enabled participants’ easy access to sports facilities at reduced rates.

Similarly, access to nutritional advice was made easy by the presence of a dietitian on site and most participants were happy to discuss their diet as part of the program.

Conclusion

This small feasibility study has demonstrated important effects on health outcomes from a pilot clinical intervention for patients with PAD. The context and intervention are reported as a novel prevention-orientated treatment that sought to improve health outcomes. The findings suggest that a larger follow-up study would include a number of specific outcome measures and economic assessment to demonstrate the effect of podiatric monitoring and exercise referral for this population. Further study is needed to examine associated behavior change factors that result from prevention services of this kind, particularly where the professional intervention is designed to mitigate the effects of chronic wounds, revascularization and amputation, particularly with the diabetic population.

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