A Multicentre Randomised Controlled Trial of the Norwegian Health in Work Service for Patients With Common Mental Disorders and Musculoskeletal Disorders: The Norwegian Sickness Absence Clinic (NSAC) Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,500
- 试验地点
- 10
- 主要终点
- Functional recovery: employment
研究概览
简要总结
The Norwegian Sickness Absence Clinic (NSAC) is a publicly funded specialist outpatient health service, which is uniquely available for the work force. The overall aim of the NSAC is prevention of sickness absence, promote return to work (RTW) among those on sickness absence and prevent long term disability benefit dependency. In addition to being a health service, the NSAC has a focus on work and functional recovery, including also non-health related factors. Patients can be referred by general practitioners for mental health problems and musculoskeletal problems. The NSAC has a lower threshold for severity than specialist health services generally, and in particular for mental health problems. The efficacy of this service is unknown.
The NSAC Efficacy Study is a randomized controlled multicentre trial which aims to assess the effect of the NSAC service. "Helse i Arbeid" is the Norwegian name for NSAC, and the Norwegian abbreviation is "HiA". The Norwegian study name is HIANOR.
The NSAC Efficacy Study involves five different NSACs across northern Norway, and will recruit 2500 patients, randomized to in equal proportions to three treatment arms:
- NSAC - rapid: treatment at the NSAC at- or within 4 weeks
- NSAC - ordinary: treatment at the NSAC after 10-14 weeks
- NSAC - active control: monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval) The overall aim is to assess the effect of the NSAC service, with the hypothesis that the NSAC service is superior to what resembles treatment as usual (TAU) for outcomes such as return to work or improved health (waiting list control). Many of the diagnoses or problems for which patients are referred to the NSACs naturally improve regardless of health interventions, and - as of date - no research has been conducted to assess the efficacy of the service.
详细描述
The Norwegian Sickness Absence Clinic (NSAC) is a publicly funded specialist outpatient health service, which is uniquely available for the work force. The overall aim of the NSAC is prevention of sickness absence, promote return to work (RTW) among those on sickness absence and prevent long term disability benefit dependency. In addition to being a health service, the NSAC has a focus on work and functional recovery, including also non-health related factors. Patients can be referred by general practitioners for mental health problems and musculoskeletal problems. The NSAC has a lower threshold for severity than specialist health services generally, and in particular for mental health problems. The efficacy of this service is unknown.
The NSAC Efficacy Study is part of a broader project, the Norwegian Sickness Absence Clinic Study (NSACS). The NSACS currently has two sources of funding: Northern Norway Regional Health Authority and The Norwegian Labour and Welfare Administration and involves two RCTs: NSAC Efficacy and NSAC Nudge and fifteen work packages concerning health economics, scalability, implementation, profiling of patient groups, and non-RCT related research questions to improve understanding of the patient group and their challenges. To do this the project will use patient survey data, clinician-reported procedures, opinions and outcomes, linked to registry data for work benefits and health service use. The randomized controlled trial NSAC Efficacy is the subject of this trial registration.
The NSAC Efficacy Study is a naturalistic randomized controlled multicentre trial, carried out in northern Norway and involving five NSACs. The study invites 2500 patients, randomized to either of three treatment arms:
- NSAC rapid: treatment at the NSAC at- or within 4 weeks
- NSAC ordinary: treatment at the NSAC after 10-14 weeks
- NSAC - active control: monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval)
The NSACs are staffed by teams of medical doctors specializing in physical medicine and rehabilitation, psychologists, physiotherapists, and employment counsellors with experience from case management in the Norwegian Labor and Welfare Administration (NAV).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* The patient must be considered eligible for treatment at the NSAC by the admission team at the NSAC.
排除标准
- •Patients considered too healthy for treatment at the NSAC, i.e. not within target group
- •Patients considered too sick for treatment at the NSAC, i.e. not within target group
- •Patients that do not have a diagnosis that is relevant for treatment at the NSAC, i.e. not within target group
- •Patients otherwise considered not within target group for the measure
- •Patients which were included in the NSAC Nudge trial (clinicaltrials identifier: NCT05006976) may not be recruited within the first year of follow-up of that trial
- •Patients which are secondary referred from other departments/clinics within the hospital
- •Non-Norwegian or non-English speaking patients
- •Patients which could not be reached by the research coordinator at the outpatient clinic for information about the study
研究组 & 干预措施
NSAC rapid: treatment at the NSAC at- or within 4 weeks
NSAC service delivered according to ordinary procedures, 4 weeks after referral.
干预措施: NSAC - rapid (Other)
NSAC ordinary: treatment at the NSAC after 10-14 weeks
NSAC service delivered according to ordinary procedures, 10-14 weeks after referral, by and large equivalent to current waiting time
干预措施: NSAC - ordinary (Other)
NSAC - active control
Monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval)
干预措施: NSAC - active control (Other)
结局指标
主要结局
Functional recovery: employment
时间窗: 12 months post baseline survey
Employment during first 365 days post baseline survey, based on registry data and self-report.
Functional recovery: sickness absence
时间窗: 12 months post baseline survey
Sickness absence during first 365 days post baseline survey, based on registry data and self-report.
Functional recovery: application for rehabilitation benefits
时间窗: 12 months post baseline survey
Application for rehabilitation benefits during first 365 days post baseline survey, based on registry data and self-report.
Functional recovery: employment long term
时间窗: 5 and 10 years post baseline survey
Employment during 5-and 10-year period post baseline survey, all based on registry data.
Functional recovery: sickness absence long term
时间窗: 5 and 10 years post baseline survey
Sickness absence during 5-and 10-year period post baseline survey, all based on registry data.
Functional recovery: rehabilitation benefits long term
时间窗: 5 and 10 years post baseline survey
Rehabilitation benefits during 5-and 10-year period post baseline survey, all based on registry data.
Functional recovery: disability benefits long term
时间窗: 5 and 10 years post baseline survey
Disability benefits during 5-and 10-year period post baseline survey, all based on registry data.
次要结局
- Pain intensity(12 months post baseline survey)
- Fear avoidance(12 months post baseline survey)
- Physical activity(12 months post baseline survey)
- Fatigue(12 months post baseline survey)
- Pain localization(12 months post baseline survey)
- Cause of pain(12 months post baseline survey)
- Self-reported diagnosis(12 months post baseline survey)
- Mental health(12 months post baseline survey)
- Depressive symptoms(12 months post baseline survey)
- Sleep(12 months post baseline survey)
- Health Anxiety(12 months post baseline survey)
- Subjective health complaints(12 months post baseline survey)
- Back pain(12 months post baseline survey)
- Neck pain(12 months post baseline survey)
- Anxiety(12 months post baseline survey)