Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study.

Abstract

BACKGROUND: Little research exists on the effectiveness of motivational interviewing (MI) on return to work (RTW) in workers on long term sick leave. The objectives of this study protocol is to describe a randomized controlled trial (RCT) with the objectives to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. METHODS: A multi-arm RCT with economic evaluation will be conducted in Norway with recruitment of 450 participants aged 18-67?years on 50-100% sick leave for >?7?weeks due to MSK disorders. Participants will be randomized to either usual case management by the Norwegian Labour and Welfare Administration (NAV) alone, usual case management by NAV plus MI, or usual case management by NAV plus SVAI. Trained caseworkers in NAV will give two MI sessions, and physiotherapists will give 1-4 SVAI sessions depending upon risk of long-term sick leave. The primary outcome is the number of sick leave days from randomization to 6?months follow-up. Secondary outcomes are number of sick leave days at 12?months follow-up, time until sustainable RTW (=4?weeks of at least 50% of their usual working hours) at 12?months, proportions of participants receiving sick leave benefits during 12?months of follow-up, and MSK symptoms influencing health at 12?months. Cost-utility evaluated by the EuroQoL 5D-5L and cost-benefit analyses will be performed. Fidelity of the interventions will be assessed through audio-recordings of approximately 10% of the intervention sessions. DISCUSSION: The results from this RCT will inform stakeholders involved in supporting RTW due to MSK disorders such as staff within NAV and primary health care. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03871712 registered March 12th 2020.