Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial

Area of Science:

• Podiatry
• Diabetology
• Health Psychology

Background:

• Diabetic foot ulcers are a significant complication of diabetes, often leading to poor treatment adherence and reduced quality of life.
• Shared decision-making (SDM) is increasingly recognized as crucial for improving patient engagement and health outcomes.

Purpose of the Study:

• To investigate if the Decision Navigation intervention, designed to enhance shared decision-making, improves decision self-efficacy and adherence to foot treatment in patients with diabetic foot ulcers.
• To evaluate the impact of Decision Navigation on secondary outcomes including ulcer healing, quality of life, decision conflict, and regret.

Main Methods:

• A pilot randomized controlled trial involving 56 patients with diabetic foot ulcers.
• Participants were assigned to either the Decision Navigation intervention (N=30) or usual care (N=26).
• Primary outcomes: decision self-efficacy, participant-reported adherence, and clinician-reported adherence. Secondary outcomes: ulcer healing rate, quality of life, decision conflict, and regret.

Main Results:

• Despite positive participant feedback on Decision Navigation, no significant differences were found in decision self-efficacy or adherence between the intervention and usual care groups.
• No significant differences were observed in secondary outcomes, except for an increase in decision conflict over 12 weeks in the Decision Navigation group.

Conclusions:

• The Decision Navigation intervention did not enhance decisional confidence or adherence to foot treatment in patients with diabetic foot ulcers.
• Findings suggest that personalized care interventions may not improve health outcomes in advanced stages of this disease trajectory.
• Future interventions should focus on enhancing patient motivation and addressing beliefs about personal control in managing diabetic foot conditions.