Development and feasibility of a multidisciplinary education program on adherence to treatment in persons with venous leg ulcers in the clinical setting: A pilot study.

AIMS

The aim of this study is to: (a) develop an evidence-based multidisciplinary educational intervention for patients with a venous leg ulcer; and (b) conduct a pilot study to assess the feasibility of the intervention in the clinical setting.

DESIGN

A two-stage study design was used: (a) an multidisciplinary expert committee designed an educational intervention including support materials; and (b) a pilot randomized controlled trial was conducted to assess the feasibility of the intervention in one wound care outpatient clinic in Western Switzerland.

METHODS

A multidisciplinary expert committee identified evidence for effective care interventions to improve venous leg ulcer patients' wound healing and recurrences rates. They subsequently designed the educational intervention and support materials. In this pilot study venous leg ulcer patients were then randomly assigned to receive multidisciplinary education or standard care from March-July 2018. The objective was to evaluate the feasibility of the intervention in the clinical setting. Allocation to groups was achieved to concealed, simple randomization. Participants and study nurses were not blinded, data analyst was blinded.

RESULTS

The intervention, including support material was developed. Twelve of 16 invited venous leg ulcer patients were recruited and randomized (control group N = 6; intervention group N = 6). Participation rate was 75%. The implementation of the intervention was feasible in the clinical setting. The performance of the Venous Leg Ulcer Self Efficacy Tool for measuring adherence to therapy and the Mini Nutritional Assessment and Frequent Food Questionnaire for the assessment of the nutritional intake was satisfactory. However, Fitbit smartwatch for measuring activity was not a suitable device in this study population.

CONCLUSION

The implementation of the designed multidisciplinary educational program was feasible. The pilot study identified weaknesses in the study protocol, which will be amended for the full-size clinical trial.

IMPACT

Findings of the pilot study informed the improvement of the design of the main study.