Making should e r p a in s imple i n g e neral p r actice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study)

Research suggests that current care for shoulder pain is not in line with the best available evidence. This project aims to assess the effectiveness, cost-effectiveness and the implementation of an evidence-based guideline for shoulder pain in general practice in Norway. A stepped-wedge, cluster-randomised trial with a hybrid design assessing clinical effectiveness, cost-effectiveness and the effect of the implementation strategy of a guideline-based intervention in general practice. We will recruit at least 36 general practitioners (GPs) and randomise the time of cross-over from treatment as usual to the implemented intervention. The intervention includes an educational outreach visit to the GPs, a computerised decision tool for GPs and a self-management application for patients. We will measure outcomes at patient and GP levels using self-report questionnaires, focus group interviews and register based data. The primary outcome measure is the patient-reported Shoulder Pain and Disability Index measured at 12 weeks. Secondary outcomes include the EuroQol Quality of Life Measure (EQ5D-5L), direct and indirect costs, patient's global perceived effect of treatment outcome, Pain Self-Efficacy and Brief Illness Perception Questionnaire. We will evaluate the implementation process with focus on adherence to guideline treatment. We will do a cost-minimisation analysis based on direct and selected indirect costs and a cost-utility analysis based on EQ5D-5L. We will use mixed effect models to analyse primary and secondary outcomes. Ethics approval was granted by the Regional Committee for Medical and Health Research Ethics-South East Norway (ref. no: 2019/104). Trial results will be submitted for publication in a peer-reviewed medical journal in accordance with Consolidated Standards of Reporting Trials. NCT04806191.