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

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, further, 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: 14067965

SupportPrim – A computerized clinical decision support system for stratified care for patients with musculoskeletal pain complaints in general practice - Statistical Analysis Plan

“…This is a statistical Analysis Plan (SAP) for "SupportPrim -A computerized clinical decision support system for strati ed care for patients with musculoskeletal pain complaints in general practice". The SAP elaborates the statistics described in the published study protocol [1].…”