一项关于在常规病例管理基础上增加动机性访谈或分层职业建议干预对肌肉骨骼疾病患者重返工作岗位有效性的随机对照试验研究方案。MI-NAV研究。
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.
作者信息
Øiestad Britt Elin, Aanesen Fiona, Løchting Ida, Storheim Kjersti, Tingulstad Alexander, Rysstad Tarjei L, Småstuen Milada C, Tveter Anne Therese, Sowden Gail, Wynne-Jones Gwenllian, Fors Egil A, van Tulder Maurits, Berg Rigmor C, Foster Nadine E, Grotle Margreth
机构信息
Department of Physiotherapy, OsloMet - Oslo Metropolitan University, St. Olavs plass, 0130, Oslo, Norway.
Research and Communication Unit for MSK Health (FORMI), Oslo University Hospital and Oslo Metropolitan University, Oslo, Norway.
出版信息
BMC Musculoskelet Disord. 2020 Jul 28;21(1):496. doi: 10.1186/s12891-020-03475-z.
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.
背景
关于动机性访谈（MI）对长期病假员工重返工作岗位（RTW）有效性的研究较少。本研究方案的目的是描述一项随机对照试验（RCT），其目的是比较单纯常规病例管理与常规病例管理加MI或常规病例管理加分层职业建议干预（SVAI）对因肌肉骨骼（MSK）疾病而病假的人员重返工作岗位的有效性和成本效益。
方法
将在挪威进行一项带有经济评估的多组RCT，招募450名年龄在18至67岁之间、因MSK疾病而50%-100%病假超过7周的参与者。参与者将被随机分配到以下三组：仅由挪威劳动和福利管理局（NAV）进行常规病例管理、NAV的常规病例管理加MI、或NAV的常规病例管理加SVAI。NAV中经过培训的个案工作者将进行两次MI课程，物理治疗师将根据长期病假风险进行1-4次SVAI课程。主要结局是从随机分组到6个月随访期间的病假天数。次要结局包括12个月随访时的病假天数、12个月时直至可持续重返工作岗位（≥4周，至少为其正常工作时间的50%）所需的时间、随访12个月期间领取病假福利的参与者比例，以及12个月时影响健康的MSK症状。将通过欧洲五维度健康量表（EuroQoL 5D-5L）进行成本效用评估并进行成本效益分析。将通过对约10%的干预课程进行录音来评估干预措施的保真度。
讨论
该RCT的结果将为参与支持因MSK疾病而重返工作岗位的利益相关者提供信息，如NAV和初级卫生保健机构的工作人员。
试验注册
ClinicalTrials.gov标识符：NCT03871712，于2020年3月12日注册。
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