GLA:D® Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study

Alice Kongsted, Inge Ris, Per Kjaer, Werner Vach, Lars Morsø, Jan Hartvigsen, Alice Kongsted, Inge Ris, Per Kjaer, Werner Vach, Lars Morsø, Jan Hartvigsen

Abstract

Background: Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel.

Methods: The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave.

Discussion: This implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice.

Trial registration: ClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

Keywords: Back pain; Exercise therapy; Health plan implementation; Patient education; Primary health care.

Conflict of interest statement

Ethics approval and consent to participate

The data collection has obtained authorisation from the Danish Data Protection Agency (DPA) as part of the University of Southern Denmark’s institutional authorisation (DPA no. 2015–57-0008 SDU no. 17/30591). The Regional Committees on Health Research Ethics for Southern Denmark decided that the study did not need ethical approval (file number S-20172000-93). When registered by the clinician, the patient receives an email with link to a patient reported survey. Written information about the study, data protection and participants’ rights are in the survey with a request to confirm consent for using data for research purposes (Additional file 2). The treatments offered to patients are not influenced by study participation. Clinicians agree to the requirements for GLA:D Back certification and consent that data are used for investigating reach and adoption when signing up for the course. Consent that data are used for research purposes in general is provided at the four-months follow-up.

Consent for publication

The manuscript does not include any individual person’s data.

Competing interests

AK’s position at the University of Southern Denmark is financially supported by the Foundation for Chiropractic Research and Postgraduate Education, and IR’s position is supported by income from the GLA:D Back clinician courses. GLA:D® is a non-profit initiative hosted at the University of Southern Denmark and the GLA:D® trademark is property of the University of Southern Denmark. The GLA:D initiative is developed in close collaboration with the SDU Research & Innovation Organisation, including legal reviews. The researchers do not have any personal financial benefits from working with the project. Since there is a substantial overlap between the developers of the intervention and the investigators of this study, we will ask members of the advisory board who are neither involved in development of the intervention nor in the study itself to take on the role of monitoring data and safety. The study team will continuously report interim results to the advisory board and discuss the need for major changes in the conduct of the study. The members of the advisory board will be given access to the data of the study on request. AK, PK, and JH are editorial board members for BMC Musculoskeletal Disorders.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The Behaviour Change Wheel. Susan Michie et al. Implementation Science 2011 6:42 [35]
Fig. 2
Fig. 2
Outline of the clinical intervention
Fig. 3
Fig. 3
The theoretical model of change at the clinician level and the patient-level
Fig. 4
Fig. 4
Illustration from the patient education explaining that pain is a result of your demands (physical, emotional and social) exceeding your capacity (physical, emotional, and cognitive)
Fig. 5
Fig. 5
Study timeline. * Clinician data collected before and after the course

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