Abstract
BackgroundReassuring 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov NCT03570463. Registered 27 June 2018.
Highlights
Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines
Evaluation of the clinical intervention The clinical intervention will be evaluated based on data about the patients who enrol in the D Back) (GLA):D Back program, i.e. those patients who are registered in the GLA:D Back registry
The implementation strategy targets clinicians and the clinical intervention targets people seeking care for persistent or recurrent low back pain (LBP) who are in need of improved self-management
Summary
Reassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. Many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. Clinical guidelines for the treatment of back pain consistently recommend educating patients about back pain and its natural courses, as well as providing advice about remaining active and at work [4, 5]. They endorse supervised exercise therapy, manual therapy alone or in combination with exercises, and acupuncture, while discouraging the referral of patients to imaging and the administration of opioids, and reserving surgery for the few with very specific indications [4,5,6]. Implementation strategies in the field of back pain have generally not been developed and evaluated within a theoretical framework [11,12,13, 16]
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