NCT06782126

A Study Protocol for the Implementation and Evaluation of a Self-management Support Program in Burns Aftercare for Burn Survivors in the Netherlands

Self-management Support After Burns: Study Protocol for a Multicenter Stepped-wedge Hybrid Type 2 Effectiveness-implementation Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 146 (estimated)
• Sponsor: Martini Hospital Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate a new self-management support intervention for burn survivors called BreeZe. The overall goal of BreeZe is to enhance burn survivors' self-management skills in order to integrate treatment and life goals and subsequently optimize burn survivors' quality of life and health-related outcomes. The BreeZe intervention is based on the content of the ZENN intervention, an evidence-based self-management support intervention for transplant recipient patients, which we adapted to the context of burn care. The BreeZe intervention is based on the theoretical framework of the Self-Regulation Theory. The main intervention strategies are based on evidence-based techniques, namely goal setting and pursuit, Solution-Focused Brief-Therapy, and Motivational Interviewing. In practice, this means that the intervention focuses on a positive approach in order to enhance burn survivors' intrinsic motivation and self-efficacy to encourage sustainable behaviour change regarding self-management in burns aftercare. To achieve this, we will implement BreeZe using various implementation strategies. These will include educating healthcare professionals on self-management, training them in communication skills (e.g. motivational interviewing), and providing supportive materials such as a decision aid tool (i.e., self-management web) and a workbook tailored for burn survivors. This multicenter stepped-wedge hybrid type 2 effectiveness-implementation study aims to evaluate BreeZe's effectiveness, and to evaluate the effects of our implementation approach. The study includes a pre-implementation phase (usual care), implementation phase, and a post-implementation phase (with BreeZe), and involves the three designated burn centers in the Netherlands. The phases will be rolled out sequentially from April 2024 to November 2024, and enrollment of participants concludes in July 2025. For evaluation, this study uses the RE-AIM evaluation framework, focusing on Reach, Effectiveness, Adoption, Implementation, and Maintenance. Our co-primary outcomes are 1) BreeZe's effectiveness in improving self-management skills in burn survivors, and 2) the effects of our implementation approach on the implementation outcomes Reach, Adoption, Implementation and Maintenance. Secondary effectiveness outcomes are self-regulation, participation, dependency, and patient-centeredness for burn survivors, and self-management support skills for healthcare professionals. Data collection for burn survivors occurs at 2 weeks, 6 months, and 12 months post-discharge, using questionnaires. Data collection for healthcare professionals occurs pre-implementation, and 3, 6 and 12 months after implementation, using questionnaires, interviews, and video observations.

Conditions

• Burns

Interventions

Type	Name	Description
BEHAVIORAL	BreeZe (Brandwonden en Zelfmanagement)	BreeZe is a self-management support program designed to enhance burn survivors' intrinsic motivation and self-efficacy for self-management after discharge. The intervention is based on the Self-Regulation Theory framework. Key strategies include evidence-based techniques such as goal setting and pursuit, Solution-Focused Brief Therapy, and Motivational Interviewing. The program takes a positive approach to boost motivation and self-efficacy, promoting sustainable behavior change in burn aftercare. BreeZe will be implemented through various strategies, including educating healthcare professionals on self-management, training them in communication skills (e.g., motivational interviewing), and providing materials such as a decision aid tool (self-management web) and a workbook tailored to burn survivors. Burn survivors will use the web to identify and prioritize problems, set personalized goals with their healthcare professional, and create an action plan for goal attainment.

Timeline

• Start date: 2024-04-15
• Primary completion: 2026-07-14
• Completion: 2026-07-14
• First posted: 2025-01-17
• Last updated: 2026-02-25

Locations

3 sites across 1 country: Netherlands