Introduction Low back pain (LBP) is a major health problem commonly requiring healthcare. In Sweden, there is a call from healthcare practitioners (HCPs) for the development, implementation and evaluation of a best practice primary healthcare model for LBP.
Aims (1) To improve and understand the mechanisms underlying changes in HCP confidence, attitudes and beliefs for providing best practice coherent primary healthcare for patients with LBP; (2) to improve and understand the mechanisms underlying illness beliefs, self-care enablement, pain, disability and quality of life in patients with LBP; and (3) to evaluate a multifaceted and sustained implementation strategy and the cost-effectiveness of the BetterBack☺ model of care (MOC) for LBP from the perspective of the Swedish primary healthcare context.
Methods This study is an effectiveness-implementation hybrid type 2 trial testing the hypothesised superiority of the BetterBack☺ MOC compared with current routine care. The trial involves simultaneous testing of MOC effects at the HCP, patient and implementation process levels. This involves a prospective cohort study investigating implementation at the HCP level and a patient-blinded, pragmatic, cluster, randomised controlled trial with longitudinal follow-up at 3, 6 and 12 months post baseline for effectiveness at the patient level. A parallel process and economic analysis from a healthcare sector perspective will also be performed. Patients will be allocated to routine care (control group) or the BetterBack☺ MOC (intervention group) according to a stepped cluster dogleg structure with two assessments in routine care. Experimental conditions will be compared and causal mediation analysis investigated. Qualitative HCP and patient experiences of the BetterBack☺ MOC will also be investigated.
Dissemination The findings will be published in peer-reviewed journals and presented at national and international conferences. Further national dissemination and implementation in Sweden and associated national quality register data collection are potential future developments of the project.
Date and version identifier 13 December 2017, protocol version 3.
Trial registration number NCT03147300; Pre-results.
- low back pain
- model of care
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Contributors AA and BÖ formulated the trial’s original aims and hypothesis. AA, KS and BÖ developed intervention materials. AA, KS, PE, PN and ÖB designed the study methodology. AA, PN and BÖ procured funding for the trial. AA, KS, PE, PN and ÖB have reviewed and finalised the protocol.
Funding This work was supported by the Research Council in Southeast Sweden (grant number: FORSS*660371) and the Swedish Research Council (grant number: 2017*01444).
Competing interests None declared.
Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval Ethical clearance for the study (Dnr: 2017-35/31) has been attained through the Regional Ethics Committee in Linköping.
Provenance and peer review Not commissioned; externally peer reviewed.