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)

Ole Marius Ekeberg, Stein Jarle Pedersen, Bård Natvig, Jens Ivar Brox, Eva Kristin Biringer, Silje Endresen Reme, Kaia Beck Engebretsen, Pål Joranger, Ibrahimu Mdala, Niels Gunnar Juel, Ole Marius Ekeberg, Stein Jarle Pedersen, Bård Natvig, Jens Ivar Brox, Eva Kristin Biringer, Silje Endresen Reme, Kaia Beck Engebretsen, Pål Joranger, Ibrahimu Mdala, Niels Gunnar Juel

Abstract

Introduction: 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.

Methods and analysis: 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 and dissemination: 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.

Trial registration number: NCT04806191.

Keywords: musculoskeletal disorders; primary care; shoulder.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Timeline. Ten clusters representing each GP surgery. Recruitment of GPs ended in January 2021 and patient inclusion will start during March 2021. All clusters start as a control (blue) and will randomly be allocated to the intervention group (yellow). Implementation will start in June 2021 and will end in June 2022. Each patient is followed for 1 year. GP, general practitioner.

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