Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 28, 2025
Date Accepted: Dec 19, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Self-management support after burns: protocol for a multicentre, stepped-wedge hybrid type II effectiveness-implementation study
ABSTRACT
Background:
After a burn injury, burn survivors have to manage and integrate the physical, psychological, and social consequences of their injury into their daily lives, such as functional limitations, aesthetic complaints, and fatigue. How successful burn survivors are at this, depends on their self-management skills. Healthcare professionals play an important role in supporting self-management of burn survivors. Currently, there are no burn-specific self-management support interventions. Therefore, we developed a self-management support intervention for burn survivors called BreeZ
Objective:
This manuscript described a study protocol to implement and evaluate the BreeZe intervention.
Methods:
This multi-centre study in the Netherlands is an implementation-effectiveness hybrid type 2 study, with a non-randomized stepped-wedge design. Starting April 2024, three phases will be sequentially rolled-out across the three specialized Dutch burn centres over a period of 20 weeks: the pre-implementation phase (usual care), implementation phase, and post-implementation phase. To identify barriers and facilitators of implementation, the Consolidated Framework for Implementation Research (CFIR) will be used. For evaluation, the RE-AIM evaluation framework, focusing on Reach, Effectiveness, Adoption, Implementation, and Maintenance is used. The co-primary outcomes are 1) self-management skills, and 2) the implementation outcomes Reach, Adoption, Implementation, and Maintenance. Secondary effectiveness outcomes are self-regulation, participation, dependency, patient-centeredness for burn survivors, self-management support skills for healthcare professionals, and cost-effectiveness. Data collection for burn survivors occurs at 2 weeks, and 6 and 12 months post-discharge, using questionnaires. Data collection for healthcare professionals occurs before training, and 3, 6, and 12 months post-implementation, using questionnaires, video observations, and interviews. Data analysis will include both quantitative and qualitative methods for comprehensive evaluation.
Results:
Participant recruitment ended on June 30, 2025. Follow-up data collection is currently ongoing and will end in July 2026.
Conclusions:
A key strength of this study is the use of the CFIR framework to identify facilitators and barriers affecting implementation, allowing us to tailor strategies accordingly and to optimize the implementation process. The RE-AIM framework ensures a comprehensive evaluation of both intervention effectiveness and implementation success. Our hybrid effectiveness-implementation design distinguishes whether outcomes result from the intervention or its implementation. To balance internal and external validity, we chose a non-randomized stepped-wedge design, considering organizational readiness and stakeholder acceptability. Finally, aligning inclusion criteria with PROMs and embedding the intervention in routine practice enhances external validity and generalizability. Clinical Trial: Clinicaltrials.gov NCT0 678 2126
Citation
