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

February 24, 2026 updated by: Martini Hospital Groningen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728NT
        • Burn Center Martini Hospital
    • North Holland
      • Beverwijk, North Holland, Netherlands, 1942LE
        • Red Cross Hospital Beverwijk
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3079DZ
        • Maasstad Hospital Rotterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-management skills
Time Frame: 2 weeks, 6 months, and 12 months after discharge from burn center
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
Time Frame: 12 months post-implementation
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
Time Frame: 12 months post-implementation
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
Time Frame: 12 months post-implementation
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
Time Frame: 12 months post-implementation
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)
Time Frame: 6 and 12 months post-implementation
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)
Time Frame: 3 and 12 months post-implementation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-regulation skills
Time Frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Self-regulation skills will be measured with the Self-Regulation Assessment (SeRA). The SeRA consists of 22 items that assess four domains of self-regulation: 1) Insight in own health condition, 2) Insight in own capabilities, 3) Trust on self and apply self-regulation, 4) Organisation of help. Answers are given on a 5-point Likert scale. Mean scores are calculated per domain, with a min-max score of 0-40. A higher score on the scale indicates a better level of self-regulation skills.
2 weeks, 6 months, and 12 months after discharge from burn center
Participation
Time Frame: 6 and 12 months after discharge from burn center
Participation will be measured with the Measure of Experiential Aspects of Participation (MeEAP). Participants will be asked if they participate on four different life domains: 1) employment, 2) mobility, 3) sport, and 4) exercise. The response options will be used to assess both participation in the activity (yes vs. no) and the individual's satisfaction with the level of participation
6 and 12 months after discharge from burn center
Daily activities
Time Frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Participants will be asked if they are capable of performing their daily activities. Daily activities will be measured with one question from the 5-level EuroQoL-5D (EQ-5D-5L). Answer options are presented on a 5-point Likert scale, with a higher score indicating better capability of performing daily activities.
2 weeks, 6 months, and 12 months after discharge from burn center
Self-care
Time Frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Participants will be asked if they are capable of performing self-care. Self-care will be measured with one question from the 5-level EuroQoL-5D (EQ-5D-5L). Answer options are presented on a 5-point Likert scale, with a higher score indicating better capability of performing self-care.
2 weeks, 6 months, and 12 months after discharge from burn center
Dependency
Time Frame: 2 weeks, 6 months, and 12 months after discharge from burn center
Participants will be asked if they are dependent on other people. Dependency will be assessed with a newly formulated question. Answer options are presented on a 5-point Likert scale with a min-max value of 1-5, with a higher score indicating less dependency on other people.
2 weeks, 6 months, and 12 months after discharge from burn center
Return to work or school
Time Frame: 6 and 12 months after discharge from burn center
Return to work or school will be measured with the Adjusted International Consortium for Health Outcomes Measurement. Participants will be asked about their daily occupation, with the following response options: 'I work 36 hours or more per week' (1), 'I work 35 hours or less per week' (2), 'I am job searching' (3), I do not have a paid job (I go to school or am studying)' (4), I do not have a paid job (retired, volunteer, stay-at-home occupation' (5), 'I cannot work because of my burn injury' (6), 'I cannot work due to other health issues' (7). Furthermore, they will be asked if their job has been adjusted since their burn injury (e.g. physical adjustments or reduced working hours), with 'yes' or 'no' as response options. Lastly, they will be asked, if suitable, how long after their burn injury they have started working or studying again.
6 and 12 months after discharge from burn center
Patient centeredness
Time Frame: 6 months after discharge from burn center
Overall experience of the received care will be assessed using the Dutch translation of the subscale 'patient-centeredness' of the American Consumer Assessment of Health Plan Survey (CAHPS). Participants will be asked if they feel listened to by their healthcare professional, if sufficient time is dedicated to their concerns, if they feel healthcare professionals take them seriously, if the healthcare professionals are able to appropriately explain things, and their level of trust in the healthcare professional's competence. Answers are measured on a 4-point Likert scale resulting in min-max values between 0-20, with higher scores indicating higher satisfaction.
6 months after discharge from burn center
Cost-effectiveness
Time Frame: 2 weeks, 6 months, and 12 months after discharge from burn center
To evaluate the cost-effectiveness of the intervention, the complete 5-level EuroQol-5D questionnaire will be used to measure the effectiveness for patients compared to the control and intervention group. The EQ-5D questionnaire consists of five dimensions: mobility, self-care, daily activities, pain/discomfort and anxiety/depression. The EQ-5D L also consists the EQ visual analogue scale (VAS). Answer options are given on a 5-point Likert scale.
2 weeks, 6 months, and 12 months after discharge from burn center
Self-management support skills
Time Frame: Before implementation, 3, 6, and 12 months post-implementation
Self-management support skills of participating healthcare professionals will be measured with the Self-efficacy and Performance in Self-management Support (SEPSS-36). The SEPSS is a 36-item questionnaire divided over 6 subscales, using a 5-point Likert-scale. Higher mean scores (overall and for subscales) indicate a higher level of self-efficacy or performance in self-management support. Min-max values for the subscales range from 0-24, and the overall min-max value range from 0-144.
Before implementation, 3, 6, and 12 months post-implementation
Need-supportive counselling
Time Frame: Before implementation, 3 and 12 months post-implementation
Need-supportive counselling will be measured using two separate taxonomies. The first taxonomy is the Coding and Observing Need-Supportive Counselling in Chronic Care Encounters (COUNSEL-CCE). The COUNSEL-CCE consists of 44 items divided into nine scales of behavioral approaches. Response options are based on a 5-point Likert scale range from 'never observed' (0) to 'all the time observed' (4). Min-max values range from 0-24, with higher scores indicating better need-supportive counselling.
Before implementation, 3 and 12 months post-implementation
Perspectives on Adoption, Implementation, and Maintenance
Time Frame: 6 months post-implementation
To explore healthcare professionals' perspectives on adoption, implementation, and maintenance, we will conduct Consolidated Framework for Implementation Research (CFIR)-informed interviews with all participating healthcare professionals. These interviews will be used to provide working hypotheses to explain the degree of adoption, to explain implementation success or failure, and to explain the degree of maintenance.
6 months post-implementation
Need-supportive counselling
Time Frame: Before implementation, 3 and 12 months post-implementation
The second taxonomy to assess need-supportive counselling is the Nurse-Child Interaction Taxonomy (NCIT). The NCIT consists of 16 items divided over 3 subdomains, scored on a 7-point scale, with higher scores indicating better need-supportive counselling.
Before implementation, 3 and 12 months post-implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martini Hospital Groningen

Collaborators

Maasstad Hospital, Rotterdam
Rode Kruis Ziekenhuis Beverwijk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

July 14, 2026

Study Completion (Estimated)

July 14, 2026

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nr. 2024-033, nr 2024-048
  • 10070022010003 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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