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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.

SUBMITTER: Oiestad BE

PROVIDER: S-EPMC7385885 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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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.

Øiestad Britt Elin BE Aanesen Fiona F Løchting Ida I Storheim Kjersti K Tingulstad Alexander A Rysstad Tarjei L TL Småstuen Milada C MC Tveter Anne Therese AT Sowden Gail G Wynne-Jones Gwenllian G Fors Egil A EA van Tulder Maurits M Berg Rigmor C RC Foster Nadine E NE Grotle Margreth M

BMC musculoskeletal disorders 20200728 1

<h4>Background</h4>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 du ...[more]

PMID: 32723318

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Project description:BackgroundMany women in the UK stop breastfeeding before they would like to, and earlier than is recommended by the World Health Organization (WHO). Given the potential health benefits for mother and baby, new ways of supporting women to breastfeed for longer are required. The purpose of this study was to develop and characterise a novel Motivational Interviewing (MI) informed breastfeeding peer-support intervention.MethodsQualitative interviews with health professionals and service providers (n?=?14), and focus groups with mothers (n?=?14), fathers (n?=?3), and breastfeeding peer-supporters (n?=?15) were carried out to understand experiences of breastfeeding peer-support and identify intervention options. Data were audio-recorded, transcribed, and analysed thematically. Consultation took place with a combined professional and lay Stakeholder Group (n?=?23). The Behaviour Change Wheel (BCW) guided intervention development process used the findings of the qualitative research and stakeholder consultation, alongside evidence from existing literature, to identify: the target behaviour to be changed; sources of this behaviour based on the Capability, Opportunity and Motivation (COM-B) model; intervention functions that could alter this behaviour; and; mode of delivery for the intervention. Behaviour change techniques included in the intervention were categorised using the Behaviour Change Technique Taxonomy Version 1 (BCTTv1).ResultsBuilding knowledge, skills, confidence, and providing social support were perceived to be key functions of breastfeeding peer-support interventions that aim to decrease early discontinuation of breastfeeding. These features of breastfeeding peer-support mapped onto the BCW education, training, modelling and environmental restructuring intervention functions. Behaviour change techniques (BCTTv1) included social support, problem solving, and goal setting. The intervention included important inter-personal relational features (e.g. trust, honesty, kindness), and the BCTTv1 needed adaptation to incorporate this.ConclusionsThe MI-informed breastfeeding peer-support intervention developed using this systematic and user-informed approach has a clear theoretical basis and well-described behaviour change techniques. The process described could be useful in developing other complex interventions that incorporate peer-support and/or MI.

Project description:Background:Diabetes and prediabetes are chronic conditions that affect over 40% of the US adult population combined. Regular physical activity can benefit people with diabetes through improved glucose control and can reduce the conversion of prediabetes to diabetes. Studies are needed in settings where people with these conditions can be identified and provided the skills and support to increase physical activity. The primary care setting meets this need, but there are insufficient high-quality trials to recommend this approach be broadly implemented. Methods:We conducted a randomized, 24-week pilot study in Southern California to assess the feasibility of using information technology systems available in primary care for identifying potential participants, test methods for obtaining physical activity clearance, conducting mail-based assessments, and delivering telephone-based motivational interviewing to increase physical activity. Eligibility criteria included age between 18 and 74?years, diabetes or prediabetes, and physically inactive based on a clinical assessment tool. At baseline and follow-up, physical activity was assessed by a 7-day accelerometry, cardiometabolic risk factors were collected from electronic medical records, and psychosocial factors were assessed from validated questionnaires administered through a mail survey. Participants were block randomized into intervention or usual care. Staff collecting outcome data were blinded to group assignment. Analysis of covariance was used to assess the difference at follow-up between the intervention and usual care, adjusting for baseline. Results:A total of 67 participants were randomized. Follow-up mail assessments were completed by 53 participants. Of 224 potential intervention calls, 194 were completed (87%). Psychosocial measures significantly improved in four of the five factors for physical activity motivation relative to participants in the usual care arm. The more internally focused factors for exercise self-regulation and outcome expectancies scores were significantly greater for participants in intervention compared with usual care. Moderate to vigorous physical activity improved in intervention participants relative to usual care, but the difference was not statistically significant. No adverse events were noted. Conclusions:The objectives of this pilot study were met. If a fully powered trial is successful, primary care settings with "behind-the-scenes" information technology support may be appropriate to increase physical activity among patients with prediabetes and diabetes. Trial registration:Exercise Promotion in Primary Care (EPPC), NCT03429088, registered on February 5, 2018.

Dataset Information

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.

Publications

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.

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