A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
- Conditions
- DepressionMusculoskeletal DisorderFatigueWork Related StressAnxiety DisordersEmploymentSickness AbsenceReturn to WorkPainOccupational Exposure
- Interventions
- Other: NSAC health onlyOther: NSAC health + MBW
- Registration Number
- NCT05006976
- Lead Sponsor
- Nordlandssykehuset HF
- Brief Summary
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.
- Detailed Description
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.
The data necessary to answer the research questions are gathered from national registries via personal identifier, registry data on population level, questionnaires filled out by the patient (data on health and working conditions) and questionnaires filled out by the clinician after each consultation (data on number of treatments, diagnosis, professions involved and types of treatment provided).
The patient questionnaire is divided in two surveys; 1) a health survey and 2) a survey on health and MBW. The health survey covers health, and includes musculoskeletal problems, mental health and other health related issues (such as alcohol consumption, medication and physical activity). The MBW survey includes working conditions (including inter alia questions on social support, work/family conflict and bullying), barriers for RTW, labour market affiliation, other personal aspects (such as demography and motivation for work), questionnaires for health economic evaluation and expectations for treatment.
By and large the questionnaire consists of test batteries which have been validated for specific topics. In an effort to reduce the number of questions posed to each patient, the baseline questionnaire will employ index questions which have proven psychometric properties in terms of factor loading or similar, meaning that if a problem on a specific topic such as neck pain is not indicated, the patient will not be presented with the Neck Disability Index questionnaire. The patient questionnaires will be filled out electronically after referral and prior to first treatment (Baseline, Time 0), as well as at 6 months after baseline (Time 1). We planned for a 12-month follow-up survey, but because of a technical error this second survey was never sent to participants. Accordingly the second follow-up survey will be sent to participants ultimo June 2024, which is in the interval between 17- and 31 months (depending on date of recruitment) after time of baseline survey (Time 2).
In the NSAC Nudge Study, receiving treatment at NSAC (Norwegian name HiA) does not presuppose consent to participate in research, but a mapping of health status is nevertheless a mandatory part of treatment. However, participation in research requires sharing these data and access to registry-based data for the involved patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1180
- For the study, the single inclusion criteria is that the patient is offered a consultation or treatment at the NSAC (Norwegian: HiA).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NSAC health only 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. NSAC health + MBW 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.
- Primary Outcome Measures
Name Time Method Functional recovery: sickness absence self-report 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: disability benefits 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 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 registry data 12 months post baseline survey Employment, sickness absence and application for rehabilitation benefits during first 365 days post baseline survey, based on registry data.
- Secondary Outcome Measures
Name Time Method Fatigue Up to 31 months post baseline survey Changes in self-reported fatigue between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Fatigue Assessment Scale. All patients are asked the first question in the test battery, and the entire instrument is provided to patients with a score of ≥ 3 on this question
Mental health Up to 31 months post baseline survey Changes in self-reported mental health between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Hopkins Symptoms Checklist - 10 (HSCL-10).
Depressive symptoms Up to 31 months post baseline survey Changes in self-reported depression between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Beck Depression Inventory (BDI). The instrument is provided to patients upon indication, defined as a HSCL-10 score \> 1.4
Health Anxiety Up to 31 months post baseline survey Changes in self-reported health anxiety between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Whitely Index. All patients are asked the first question in the test battery, and the entire instrument is provided to patients with a score of \>3 on this question
Subjective health complaints Up to 31 months post baseline survey Changes in subjective health between Time 0 and Time 1, and between Time 0 and Time 2, measured using a modified version of the Ursin Health Inventory.
Pain intensity Up to 31 months post baseline survey Changes in self-reported pain intensity between Time 0 and Time 1, and between Time 0 and Time 2, measured using a visual analogue scale scored between 0 and 10. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on pain intensity during rest and activity.
Fear avoidance Up to 31 months post baseline survey Changes in self-reported fear avoidance between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Fear Avoidance Beliefs Questionnaire (FABQ). All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided the FABQ.
Pain localization Up to 31 months post baseline survey Changes in self-reported localization of pain between Time 0 and Time 1, and between Time 0 and Time 2. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain.
Cause of pain Up to 31 months post baseline survey Changes in self-reported cause of pain between Time 0 and Time 1, and between Time 0 and Time 2. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on the believed cause of pain.
Anxiety Up to 31 months post baseline survey Changes in self-reported anxiety between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Beck Anxiety Inventory (BAI). The instrument is provided to patients upon indication, defined as a HSCL-10 score \> 1.4
Sleep Up to 31 months post baseline survey Changes in self-reported sleep between Time 0 and Time 1, and between Time 0 and Time 2, measured using 3 questions commonly used to diagnose sleeping disorder according to the DSM-IV criteria for insomnia.
Physical activity Up to 31 months post baseline survey Changes in self-reported level of physical between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Saltin-Grimby Physical Activity Level Scale (SGPALS).
Back pain Up to 31 months post baseline survey Changes in self-reported back pain Time 0 and Time 1, and between Time 0 and Time 2, measured using the Oswestry Disability Index (ODI). All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain. In case of back pain, patients are provided the ODI.
Neck pain Up to 31 months post baseline survey Changes in self-reported neck pain between Time 0 and Time 1, and between Time 0 and Time 2, measured using the Neck Disability Index (NDI). All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain. In case of neck pain, patients are provided the NDI.
Self-reported diagnoses Up to 31 months post baseline survey Changes in self-reported diagnoses between Time 0 and Time 1, and between Time 0 and Time 2. The respondent is asked whether he/she thinks they have Covid-19 sequelae, myalgic encephalomyelitis/chronic fatigue syndrome, whiplash, fibromyalgia, hypermobility, irritable bowel syndrome or food intolerance, or whether they have been diagnosed with either of these by health personnel.
Trial Locations
- Locations (5)
Helse I Arbeid Finnmarkssykehuset
🇳🇴Kirkenes, Troms Og Finnmark, Norway
Opptreningssenteret i Finnmark
🇳🇴Alta, Troms Og Finnmark, Norway
Helse I Arbeid Nordlandssykehuset
🇳🇴Bodø, Nordland, Norway
Helse I Arbeid Helgelandssykehuset
🇳🇴Sandnessjøen, Nordland, Norway
Helse I Arbeid Universitetssykehuset Nord-Norge
🇳🇴Tromsø, Troms Og Finnmark, Norway