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

doi:10.1136/bmjopen-2021-051656

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)

BMJ Open. 2022 Jan 7;12(1):e051656. doi: 10.1136/bmjopen-2021-051656.

Authors

Affiliations

¹ Department of Research and innovation, Helse Fonna HF, Haugesund, Norway.
² Department of General Practice, University of Oslo, Oslo, Norway.
³ Department of Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway j.i.brox@medisin.uio.no.
⁴ Medical Faculty, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.
⁵ Department of Psychology, University of Oslo, Oslo, Norway.
⁶ Department of Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway.
⁷ Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway.

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cost-Benefit Analysis
Family Practice
General Practice*
Humans
Quality of Life
Randomized Controlled Trials as Topic
Shoulder Pain* / diagnosis
Shoulder Pain* / therapy

Associated data

ClinicalTrials.gov/NCT04806191