Return to Work for People With Musculoskeletal Disorders: A Randomized Controlled Trial of the Effectiveness of Usual Case Management Compared to Usual Case Management Plus Motivational Interviewing or Stratified Vocational Advice Intervention. The MI-NAV Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Sickness absence days
研究概览
简要总结
Musculoskeletal disorders are the main causes for sickness absence and disability benefits in Norway and the leading causes of disability worldwide. There is strong evidence that long-term sickness absence due to musculoskeletal disorders provides a poor prognosis, both in terms of work-related disability, physical and mental health, and health related quality-of-life. To assist people return to work a range of vocational rehabilitation programs exist, but the initiatives have not been able to reduce the number of people who are on sick leave due to musculoskeletal disorders. In Norway, The Norwegian Labour and Welfare Administration (NAV) case-workers have taken such approaches in use, primarily by teaching their employees with user contact in how to use Motivational Interviewing (MI). However, the evidence on the effectiveness of MI on return to work is highly uncertain. The objectives of this project are 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. All musculoskeletal diagnoses will be included. A multi-arm randomised controlled trial with 150 participants in each group will be conducted within the NAV system in Norway to evaluate these research questions.
详细描述
The main objective of this project is to evaluate the effectiveness of usual case management plus motivational interviewing (MI), provided by trained Norwegian Labour and Welfare Administration (NAV) case-workers, and usual case management plus a Stratified Vocational Advice Intervention (SVAI), including principles of MI and vocational advice provided by trained physiotherapists, compared to usual case management alone on return to work among people on sick leave due to a musculoskeletal disorder. A multi-arm randomised controlled trial (RCT) will be conducted in order to respond to the following specific research questions:
RQ 1a Is there a difference between usual case management plus MI and usual case management alone in reducing sickness absence days at 6 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 1b Is there a difference between usual case management plus SVAI and usual case management alone in reducing sickness absence days at 6 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 2a Is there a difference between usual case management plus MI and usual case management alone in reducing sickness absence days at 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
RQ 2b Is there a difference between usual case management plus SVAI and usual case management alone in reducing sickness absence days at 12 months follow-up among individuals who have been on sick leave for >7 weeks due to a musculoskeletal disorder?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
In the written consent, the three groups will be described. Thus the participants will understand which group they are in after the first telephone call, and consequently not be blinded. The interventions are:
- Motivational interview by 2 meetings between participant and the NAV case-worker. Both the NAV case-workers and the participants will know that the intervention is motivational interviewing because it is only in this arm a NAV case-worker will do the intervention.
- Stratified vocational advice intervention (SVAI): a physiotherapist will call the study participants, and both the physiotherapist and the participants will know that they are in the SVAI intervention group from the informed consent.
The researchers will be blinded to group allocation throughout the study recruitment and assessment up to the 6-month follow-up.
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have musculoskeletal disorders
- •Live in South-East Norway
- •Have been on sick leave for 8 weeks with a current sick-leave status of 50%-100%
- •Have a job to return to
排除标准
- •Have serious somatic or psychological disorders (e.g. cancer, psychotic disorders)
- •Have specific disorder requiring specialized, ongoing treatment;
- •Are pregnant
- •Are self-employed or work free lance
- •Have insufficient Norwegian or English speaking or writing skills to participate in group session and fill out questionnaire.
结局指标
主要结局
Sickness absence days
时间窗: 6 months
Total number of sickness absence days up to the 6-month's follow-up
次要结局
- Sickness absence days(12 months)
- Medical benefits(12 months)
- Cost-effectiveness(12 months)
- Sustainable return to work(12 months)
- Musculoskeletal health(12 months)
- Cost-utility(12 months)
研究者
Britt Elin Øiestad
Associate Professor
Oslo Metropolitan University