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

NCT06782126 | Active Not Recruiting

• 2 other identifiers: nr. 2024-033, nr 2024-04810070022010003
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Burns; self-management; self-care; implementation; complex intervention

Outcome Measures

Primary Outcomes (7)

• Self-management skills

  The primary outcome measure is self-management skills, assessed using the revised Partners in Health (PIH) scale. This 12-item questionnaire measures self-management behavior and knowledge, with scores on a 9-point Likert scale (higher scores indicate better self-management). Two subscales are identified in the Dutch PIH: 1) knowledge and coping, and 2) recognition and management of symptoms, adherence to treatment. Higher scores reflect better self-management skills. The PIH scale has good construct validity and reliability, with Cronbach's alpha ranging from 0.82 to 0.86. Test-retest reliability, as measured by the intraclass correlation coefficient, ranges from 0.77 to 0.818 across different language versions. While no data on responsiveness is available, the PIH consistently provides valid evidence of self-management skills in patients with chronic conditions.

  2 weeks, 6 months, and 12 months after discharge from burn center

• Reach

  To determine reach, participant demographics will be compared to non-participants using the Dutch Burn Repository R3. We will compare the following characteristics: sex (m/f), age (years), total body surface area burned (%), operation (yes/no), and length of stay (days).

  12 months post-implementation

• Adoption

  Adoption at staff level will be assessed by comparing the total percentage of participating healthcare professionals to the total percentage of healthcare professionals who were invited to participate, which will be quantified in percentages. Participation is defined as the completion of the three training components (i.e., e-learning, face-to-face training, follow-up training).

  12 months post-implementation

• Implementation - Intervention fidelity

  To gain insight into the intervention fidelity to the core components, healthcare professionals will be asked to document in patient records when they have used certain components. A convenience sample will be taken by assessing patient records to investigate how often the core components were used, which will be described using descriptive statistics.

  12 months post-implementation

• Implementation - implementation fidelity

  To gain insight in the implementation fidelity to the implementation strategies, each burn center will be asked to keep track of the completion of the implementation plan, including the staff attendance to training plan and their e-learning completion rate. Implementation fidelity will be quantified using descriptive statistics.

  12 months post-implementation

• Maintenance (individual level)

  Maintenance will be assessed by the healthcare professionals' self-report of continued use using the Provider REport of Sustainment Scale (PRESS). The PRESS measure is a brief, reliable, and valid three-item measure of sustainment that is both pragmatic and useable across different evidence based practices (EBPs), provider types, and settings. The PRESS captures frontline staffs' report of their clinic, team, or agency's continued use of an EBP. It is measured on a 5-point Likert scale, with higher scores indicating better maintenance.

  6 and 12 months post-implementation

• Maintenance (setting level)

  Setting-level maintenance will be assessed via the Clinical Sustainability Assessment Tool (CSAT). The CSAT is a brief and reliable instrument consisting of 35 items within seven domains to assess an institution's capacity for sustaining a clinical practice. These domains include Engaged Staff \& Leadership, Engaged Stakeholders, Organizational Readiness, Workflow Integration, Implementation \& Training, Monitoring \& Evaluation and Outcomes \& Effectiveness. Each domain includes five items that are scored on a 7-point Likert scale, where 7 indicates an individual believes their institution has that domain to a great extent. Each domain has a min-max value of 5-35, with higher scores indicating better maintenance.

  3 and 12 months post-implementation

Secondary Outcomes (12)

• Self-regulation skills

  2 weeks, 6 months, and 12 months after discharge from burn center

• Participation

  6 and 12 months after discharge from burn center

• Daily activities

  2 weeks, 6 months, and 12 months after discharge from burn center

• Self-care

  2 weeks, 6 months, and 12 months after discharge from burn center

• Dependency

  2 weeks, 6 months, and 12 months after discharge from burn center

Study Arms (2)

Pre-implementation group

Burn survivors who did not receive aftercare according to the BreeZe program

Post-implementation group

Burn survivors who received aftercare according to the BreeZe program

Behavioral: BreeZe (Brandwonden en Zelfmanagement)

Interventions

BreeZe (Brandwonden en Zelfmanagement) BEHAVIORAL

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.

Post-implementation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Emergency Management of Severe Burns (EMSB) referral criteria guide the decision to refer burn patients to a specialized burn center. Criteria for referral include: 1) total burned body surface area (TBSA) \>10%, 2) \>5% full-thickness burns, 3) circular burns around the neck, thorax, or extremities, 4) burns around functional areas, 5) burns with other trauma, 6) chemical burns, 7) pre-existing diseases, or 8) electrical burns. Minor burns may be managed in tertiary trauma centers or non-burn facilities, but most burn survivors are either directly admitted or transferred to a burn center. In the Netherlands, approximately 800 burn survivors are admitted to one of the three designated burn centers annually. These centers meet specific criteria for expertise, facilities, and quality of care to provide optimal treatment for burn patients.

You may qualify if:

• years or older
• Admission in one of the burn centers \> 24 hours and/or debridement or skin graft operation
• Proficiency of the Dutch language

You may not qualify if:

• Acute psychiatric illness
• Cognitive limitations
• Discharge to a different healthcare institution

Sponsors & Collaborators

• Martini Hospital Groningen: lead
• Maasstad Hospital, Rotterdam: collaborator
• Rode Kruis Ziekenhuis Beverwijk: collaborator

Study Sites (3)

Red Cross Hospital Beverwijk

Beverwijk, North Holland, 1942LE, Netherlands

Location

Maasstad Hospital Rotterdam

Rotterdam, South Holland, 3079DZ, Netherlands

Location

Burn Center Martini Hospital

Groningen, 9728NT, Netherlands

Location

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MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: April 15, 2024
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

NL (3)