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General practice / Family practice
Protocol
Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study)
  1. Ole Marius Ekeberg1,
  2. Stein Jarle Pedersen2,
  3. Bård Natvig2,
  4. Jens Ivar Brox3,4,
  5. Eva Kristin Biringer1,
  6. Silje Endresen Reme5,
  7. Kaia Beck Engebretsen3,
  8. Pål Joranger6,
  9. Ibrahimu Mdala2,
  10. Niels Gunnar Juel2,3
  1. 1Department of Research and innovation, Helse Fonna HF, Haugesund, Norway
  2. 2Department of General Practice, University of Oslo, Oslo, Norway
  3. 3Department of Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway
  4. 4Medical Faculty, Institute for Clinical Medicine, University of Oslo, Oslo, Norway
  5. 5Department of Psychology, University of Oslo, Oslo, Norway
  6. 6Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway
  1. Correspondence to Dr Jens Ivar Brox; j.i.brox{at}medisin.uio.no

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.

  • shoulder
  • musculoskeletal disorders
  • primary care
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2021-051656

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    Footnotes

    • Contributors OME, SJP, BN, JIB, EKB, SER, KBE, PJ, IM and NGJ contributed to the development and design of the study. SJP, OME, NGJ and BN will carry out the study. NGJ, SJP and OME will coordinate the study. OME drafted this manuscript. All authors critically read and modified the study protocol and previous drafts of the manuscript and approved the final version.

    • Funding This work was supported by the Western Norway Regional Health Authority grant number F-11517 and the Norwegian Research Fund for General Practice.

    • Disclaimer This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.