A Naturalistic Trial of Nudging Patients and Clinicians in the Norwegian Sickness Absence Clinics- The NSAC Nudge Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,180
- 试验地点
- 10
- 主要终点
- Functional recovery: disability benefits
研究概览
简要总结
The Norwegian Sickness Absence Clinic (NSAC) Nudge Study is a naturalistic randomized controlled multicentre trial which aim is to measure the efficacy of nudging clinicians' attention towards patients' motivation for work, barriers for return to work and work environment challenges, on functional recovery as primary outcome, and health outcomes as secondary outcome.
Patients will be recruited in five different NSACs across northern Norway. In total 1100 patients will be randomized to two equal probability treatment arms: 1) NSAC with the nudge, and 2) NSAC without the nudge. The nudge is tailored to the individual patient's needs using survey, and the clinicians are presented with a summary of this patient survey prior to consultations highlighting health problems and challenges as reported by the patient in the survey.
详细描述
The NSAC Nudge Study is part of a broader project, the Norwegian Sickness Absence Clinic Study (NSACS). The NSACS has two sources of funding (Northern Norway Regional Health Authority and The Norwegian Labour and Welfare Administration (NAV)), and involves two RCTs (NSAC Nudge and NSAC Efficacy) and fifteen work packages covering aspects of efficacy, interactions in efficacy, scalability, health economics, and characteristics of the target group and the patient group. The randomized controlled trial (RCT) NSAC Nudge is the subject of this trial registration. A list of the associated work-packages (WPs) is available in the protocol attached this registration at a later time point.
The NSAC Nudge Study is a randomized controlled multicentre trial, carried out in northern Norway and involving 5 Norwegian Sickness Absence Clinics (NSAC [Helse i Arbeid]). The study will recruit 1100 patients, randomized in equal proportions to either of two treatment arms 1) Treatment at the NSAC following a patient survey of health problems and 2) treatment at the NSAC following a patient survey of health problems as well as a survey on motivation for work, barriers for return to work and work environment (MBW).
The NSACs are staffed by teams of medical doctors specializing in physical medicine and rehabilitation, psychologists, physiotherapists and employment support supervisors. The NSAC service aims to provide quick clarification of health problems or treatment to patients with common mental disorders or musculoskeletal health problems with the goals of functional improvement, prevention of long-term sickness absence and return to work.
All patients are asked to fill out an online survey about their health and MBW factors between time of referral and their first treatment. The survey will also handle randomization. The NSAC clinicians are given a summary to be used in the treatment of the individual patient, and the effect of this comprehensive mapping and the provision of a condensed report to clinician prior to consultation is the primary aim of the RCT. The clinicians will be trained in how providing this information is going to guide clinical practice and using this information in treatment of patients.
The anticipated mechanism of the nudge is 1) an increased expectation among patients that MBW factors will be addressed during treatment, and/or 2) an increased focus on MBW factors by clinician in treatment, both due to the report and the patients' expectations. Whether this mechanism has an effect on patients' return to work (RTW) outcomes, prevention of sickness absence and general alleviation of symptoms will also be explored.
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 (Participant, Outcomes Assessor)
盲法说明
The participant is masked to which questionnaire he/she fills out. The primary outcome is functional recovery, operationalized in the short term as prevention of sickness absence or return to work, and in the long term as employment or disability benefits. To this end, registry data on employment status or qualification for disability benefits is applied. Clinicians (usually the patient's general practitioner) and case managers involved in decisions on medically certified sickness absence and disability benefits are blinded to randomization.
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the study, the single inclusion criteria is that the patient is offered a consultation or treatment at the NSAC (Norwegian: HiA).
排除标准
- •Aged younger than 23 years at time of referral. The NSACs have guidelines that describe eligibility for treatment, and excludes patients that are either too healthy for the measure, too sick for the measure, not relevant diagnosis or otherwise not considered being in the target group for the measure.
研究组 & 干预措施
NSAC health only
Treatment as usual (TAU) at NSAC, following a digital survey of health problems and the provision of a condensed report of this survey to clinician prior to consultation.
干预措施: NSAC health only (Other)
NSAC health + MBW
Treatment as usual (TAU) at NSAC, following a digital survey of health problems as well as Motivation, Barriers for return to work and Work environment (MBW), and the provision of a condensed report of this survey to clinician prior to consultation.
干预措施: NSAC health + MBW (Other)
结局指标
主要结局
Functional recovery: disability benefits
时间窗: 60 months post baseline survey
Employment, sickness absence, rehabilitation benefits and disability benefits during 5-year period post baseline survey, all based on registry data.
Functional recovery: status, plan and prognosis for employment versus sickness absence
时间窗: At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC)
Clinician report at last consultation of current status, plan and prognosis for patient employment versus sickness absence. Status is current employment versus sickness absence, plan refers to patients own ambition and plans for employment versus sickness absence short term, while prognosis refers to the clinicians assessment of prognosis for employment versus sickness absence in 12 months.
Functional recovery: sickness absence self-report
时间窗: Up to 31 months post baseline survey
Employment, sickness absence and application for rehabilitation benefits between Time 0 and Time 2, based on patient self-report.
Functional recovery: sickness absence registry data
时间窗: 12 months post baseline survey
Employment, sickness absence and application for rehabilitation benefits during first 365 days post baseline survey, based on registry data.
次要结局
- Mental health(Up to 31 months post baseline survey)
- Depressive symptoms(Up to 31 months post baseline survey)
- Health Anxiety(Up to 31 months post baseline survey)
- Subjective health complaints(Up to 31 months post baseline survey)
- Pain intensity(Up to 31 months post baseline survey)
- Fear avoidance(Up to 31 months post baseline survey)
- Pain localization(Up to 31 months post baseline survey)
- Cause of pain(Up to 31 months post baseline survey)
- Anxiety(Up to 31 months post baseline survey)
- Sleep(Up to 31 months post baseline survey)
- Back pain(Up to 31 months post baseline survey)
- Neck pain(Up to 31 months post baseline survey)
- Physical activity(Up to 31 months post baseline survey)
- Fatigue(Up to 31 months post baseline survey)
- Self-reported diagnoses(Up to 31 months post baseline survey)