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

Last updated: January 13, 2025
Sponsor: Martini Hospital Groningen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Skin Wounds

Treatment

BreeZe (Brandwonden en Zelfmanagement)

Clinical Study ID

NCT06782126
nr. 2024-033, nr 2024-048
10070022010003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • Admission in one of the burn centers > 24 hours and/or debridement or skin graftoperation

  • Proficiency of the Dutch language

Exclusion

Exclusion Criteria:

  • Acute psychiatric illness

  • Cognitive limitations

  • Discharge to a different healthcare institution

Study Design

Total Participants: 146
Treatment Group(s): 1
Primary Treatment: BreeZe (Brandwonden en Zelfmanagement)
Phase:
Study Start date:
April 15, 2024
Estimated Completion Date:
July 14, 2026

Connect with a study center

  • Red Cross Hospital Beverwijk

    Beverwijk, Noord-Holland 1942LE
    Netherlands

    Active - Recruiting

  • Maasstad Hospital Rotterdam

    Rotterdam, Zuid-Holland 3079DZ
    Netherlands

    Active - Recruiting

  • Burn Center Martini Hospital

    Groningen, 9728NT
    Netherlands

    Active - Recruiting

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