SupportPrim—a computerized clinical decision support system for stratified care for patients with musculoskeletal pain complaints in general practice: study protocol for a randomized controlled trial

Naterstad Lervik, Lars Christian ; Vasseljen, Ottar; Austad, Bjarne; Bach, Kerstin; Formo Bones, Anita; Granviken, Fredrik; Hill, Jonathan C; Jørgensen, Pål; Øien, Torbjørn; Veites, Paola Marin; Van Der Windt, Danielle A; Meisingset, Ingebrigt

Abstract

Background
Musculoskeletal disorders represented 149 million years lived with disability world-wide in 2019 and are the main cause of years lived with disability worldwide. Current treatment recommendations are based on “one-size fits all” principle, which does not take into account the large degree of biopsychosocial heterogeneity in this group of patients. To compensate for this, we developed a stratified care computerized clinical decision support system for general practice based on patient biopsychosocial phenotypes; furthermore, we added personalized treatment recommendations based on specific patient factors to the system. In this study protocol, we describe the randomized controlled trial for evaluating the effectiveness of computerized clinical decision support system for stratified care for patients with common musculoskeletal pain complaints in general practice. The aim of this study is to test the effect of a computerized clinical decision support system for stratified care in general practice on subjective patient outcome variables compared to current care.

Methods
We will perform a cluster-randomized controlled trial with 44 general practitioners including 748 patients seeking their general practitioner due to pain in the neck, back, shoulder, hip, knee, or multisite. The intervention group will use the computerized clinical decision support system, while the control group will provide current care for their patients. The primary outcomes assessed at 3 months are global perceived effect and clinically important improvement in function measured by the Patient-Specific Function Scale (PSFS), while secondary outcomes include change in pain intensity measured by the Numeric Rating Scale (0–10), health-related quality of life (EQ-5D), general musculoskeletal health (MSK-HQ), number of treatments, use of painkillers, sick-leave grading and duration, referral to secondary care, and use of imaging.

Discussion
The use of biopsychosocial profile to stratify patients and implement it in a computerized clinical decision support system for general practitioners is a novel method of providing decision support for this patient group. The study aim to recruit patients from May 2022 to March 2023, and the first results from the study will be available late 2023.

Trial registration
The trial is registered in ISRCTN 11th of May 2022: 14,067,965.

• Journal Article Type: Article
• Acceptance Date: Mar 23, 2023
• Online Publication Date: Apr 11, 2023
• Deposit Date: May 26, 2023
• Publicly Available Date: May 26, 2023
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 24
• Issue: 1
• Article Number: 267
• DOI: https://doi.org/10.1186/s13063-023-07272-6
• Keywords: Pharmacology (medical); Medicine (miscellaneous) Musculoskeletal disorders; General practice; Musculoskeletal pain; Computerized clinical decision support systems; Clinical decision-making; Electronic health records; Information technology; Online systems
• Related Public URLs: https://www.researchsquare.com/article/rs-2608193/v1
• Additional Information: Received: 27 February 2023; Accepted: 23 March 2023; First Online: 11 April 2023; : ; : The Regional Ethical Committee for medical and health research defined the study outside the Norwegian Health Research Act, and thus, the study does not need an ethical approval reference: REC North Norway 376060. Regional Committee for Medical Research Ethics—Mid Norway ref. 303331. Participants provide their informed consent to participate in the trial. The study is registered in and approved by SIKT—Norwegian Agency for Shared Services in Education and Research.; : Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and online informed consent form are available from the corresponding author on request.; : The authors declare that they have no competing interests.