Clinical trial NCT06782126: A Study Protocol for the Implementation and Evaluation of a Self-management Support Program in Burns Aftercare for Burn Survivors in the Netherlands
Official title: Self-management Support After Burns: Study Protocol for a Multicenter Stepped-wedge Hybrid Type 2 Effectiveness-implementation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burns
Keywords: Burns
self-management
self-care
implementation
complex intervention
Lead sponsor: Martini Hospital Groningen
Sponsor class: OTHER
Collaborators: name: Maasstad Hospital, Rotterdam
name: Rode Kruis Ziekenhuis Beverwijk
First posted: 2025-01-17
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-management skills
timeFrame: 2 weeks, 6 months, and 12 months after discharge from burn center
measure: Reach
timeFrame: 12 months post-implementation
measure: Adoption
timeFrame: 12 months post-implementation
measure: Implementation - Intervention fidelity
timeFrame: 12 months post-implementation
measure: Implementation - implementation fidelity
timeFrame: 12 months post-implementation
measure: Maintenance (individual level)
timeFrame: 6 and 12 months post-implementation
measure: Maintenance (setting level)
timeFrame: 3 and 12 months post-implementation
Secondary outcomes:
measure: Self-regulation skills
timeFrame: 2 weeks, 6 months, and 12 months after discharge from burn center
measure: Participation
timeFrame: 6 and 12 months after discharge from burn center
measure: Daily activities
timeFrame: 2 weeks, 6 months, and 12 months after discharge from burn center
measure: Self-care
timeFrame: 2 weeks, 6 months, and 12 months after discharge from burn center
measure: Dependency
timeFrame: 2 weeks, 6 months, and 12 months after discharge from burn center
measure: Return to work or school
timeFrame: 6 and 12 months after discharge from burn center
measure: Patient centeredness
timeFrame: 6 months after discharge from burn center
measure: Cost-effectiveness
timeFrame: 2 weeks, 6 months, and 12 months after discharge from burn center
measure: Self-management support skills
timeFrame: Before implementation, 3, 6, and 12 months post-implementation
measure: Need-supportive counselling
timeFrame: Before implementation, 3 and 12 months post-implementation
measure: Perspectives on Adoption, Implementation, and Maintenance
timeFrame: 6 months post-implementation
measure: Need-supportive counselling
timeFrame: Before implementation, 3 and 12 months post-implementation
Other outcomes:
Locations:
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital Beverwijk
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital Rotterdam
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Burn Center Martini Hospital
Study officials:
References:
citation: Spronk I, van Uden D, van Dammen L, van Baar ME, Nieuwenhuis M, Pijpe A, Visser I, van Schie C, van Zuijlen P, Haanstra T, Lansdorp CA; Dutch Burn Care, Education & Research group. Outcomes that matter most to burn patients: A national multicentre survey study in the Netherlands. Burns. 2024 Feb;50(1):31-40. doi: 10.1016/j.burns.2023.10.018. Epub 2023 Nov 10.
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
citation: Caron JG, Martin Ginis KA, Rocchi M, Sweet SN. Development of the Measure of Experiential Aspects of Participation for People With Physical Disabilities. Arch Phys Med Rehabil. 2019 Jan;100(1):67-77.e2. doi: 10.1016/j.apmr.2018.08.183. Epub 2018 Sep 27.
citation: Petkov J, Harvey P, Battersby M. The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010 Sep;19(7):1079-85. doi: 10.1007/s11136-010-9661-1. Epub 2010 May 1.
citation: Maes S, Karoly P. Self-regulation assessment and intervention in physical health and illness: A review. Appl Psychol. 2005;54:267-299. doi:10.1111/j.1464-0597.2005.00210.x.
citation: Dokter J, Vloemans AF, Beerthuizen GI, van der Vlies CH, Boxma H, Breederveld R, Tuinebreijer WE, Middelkoop E, van Baar ME; Dutch Burn Repository Group. Epidemiology and trends in severe burns in the Netherlands. Burns. 2014 Nov;40(7):1406-14. doi: 10.1016/j.burns.2014.03.003. Epub 2014 Apr 2.
citation: Arah OA, ten Asbroek AH, Delnoij DM, de Koning JS, Stam PJ, Poll AH, Vriens B, Schmidt PF, Klazinga NS. Psychometric properties of the Dutch version of the Hospital-level Consumer Assessment of Health Plans Survey instrument. Health Serv Res. 2006 Feb;41(1):284-301. doi: 10.1111/j.1475-6773.2005.00462.x.
citation: Delnoij DM, ten Asbroek G, Arah OA, de Koning JS, Stam P, Poll A, Vriens B, Schmidt P, Klazinga NS. Made in the USA: the import of American Consumer Assessment of Health Plan Surveys (CAHPS) into the Dutch social insurance system. Eur J Public Health. 2006 Dec;16(6):652-9. doi: 10.1093/eurpub/ckl023. Epub 2006 Mar 8.
citation: Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.
citation: Mol TI, van Bennekom CAM, Scholten EWM, Visser-Meily JMA, Beckerman H, Passier PECA, Smeets RJEM, Schiphorst Preuper HR, Post MWM. The Self-Regulation Assessment (SeRA) questionnaire: development and exploratory analyses of a new patient-reported outcome measure for rehabilitation. Disabil Rehabil. 2023 Jun;45(12):2038-2045. doi: 10.1080/09638288.2022.2080289. Epub 2022 Jun 7.
citation: Chiu TM, Tam KT, Siu CF, Chau PW, Battersby M. Validation study of a Chinese version of Partners in Health in Hong Kong (C-PIH HK). Qual Life Res. 2017 Jan;26(1):199-203. doi: 10.1007/s11136-016-1315-5. Epub 2016 May 23.
citation: Hudon E, Chouinard MC, Krieg C, Lambert M, Joober H, Lawn S, Smith D, Lambert S, Hudon C. The French adaptation and validation of the Partners in Health (PIH) scale among patients with chronic conditions seen in primary care. PLoS One. 2019 Oct 23;14(10):e0224191. doi: 10.1371/journal.pone.0224191. eCollection 2019.
citation: Lenferink A, Effing T, Harvey P, Battersby M, Frith P, van Beurden W, van der Palen J, Paap MC. Construct Validity of the Dutch Version of the 12-Item Partners in Health Scale: Measuring Patient Self-Management Behaviour and Knowledge in Patients with Chronic Obstructive Pulmonary Disease. PLoS One. 2016 Aug 26;11(8):e0161595. doi: 10.1371/journal.pone.0161595. eCollection 2016.