Clinical trial NCT05006976: A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
Official title: A Naturalistic Trial of Nudging Patients and Clinicians in the Norwegian Sickness Absence Clinics- The NSAC Nudge Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Musculoskeletal Disorder
Anxiety Disorders
Depression
Fatigue
Pain
Occupational Exposure
Work Related Stress
Workplace Bullying
Employment
Sickness Absence
Return to Work
Keywords: Return to work
Sickness absence
Nudge
Barriers for return to work
Motivation for work
Demand and control
Work/family conflict
Bullying
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
name: Opptreningssenteret i Finnmark (Alta, Norway)
name: Helgeland Hospital Trust
name: Finnmarkssykehuset HF (Kirkenes, Norway)
name: UiT The Arctic University of Norway
First posted: 2021-08-16
Enrollment: 1180
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized in equal proportions to fill out either of two different questionnaires, consisting either of 1) health related questions only or 2) health related questions as well as questions concerning motivation for work, barriers for return to work and work environment. In both treatment arms, clinicians receive a summary of patient survey information on mental health and musculoskeletal pain. In the intervention arm, clinicians are nudged to have particular attention towards motivation for work, barriers for return to work and work environment.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* For the study, the single inclusion criteria is that the patient is offered a consultation or treatment at the NSAC (Norwegian: HiA).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Functional recovery: status, plan and prognosis for employment versus sickness absence
timeFrame: At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC)
measure: Functional recovery: sickness absence self-report
timeFrame: Up to 31 months post baseline survey
measure: Functional recovery: sickness absence registry data
timeFrame: 12 months post baseline survey
measure: Functional recovery: disability benefits
timeFrame: 60 months post baseline survey
Secondary outcomes:
measure: Mental health
timeFrame: Up to 31 months post baseline survey
measure: Anxiety
timeFrame: Up to 31 months post baseline survey
measure: Depressive symptoms
timeFrame: Up to 31 months post baseline survey
measure: Sleep
timeFrame: Up to 31 months post baseline survey
measure: Health Anxiety
timeFrame: Up to 31 months post baseline survey
measure: Subjective health complaints
timeFrame: Up to 31 months post baseline survey
measure: Back pain
timeFrame: Up to 31 months post baseline survey
measure: Neck pain
timeFrame: Up to 31 months post baseline survey
measure: Pain intensity
timeFrame: Up to 31 months post baseline survey
measure: Fear avoidance
timeFrame: Up to 31 months post baseline survey
measure: Physical activity
timeFrame: Up to 31 months post baseline survey
measure: Fatigue
timeFrame: Up to 31 months post baseline survey
measure: Pain localization
timeFrame: Up to 31 months post baseline survey
measure: Cause of pain
timeFrame: Up to 31 months post baseline survey
measure: Self-reported diagnoses
timeFrame: Up to 31 months post baseline survey
Other outcomes:
measure: Preventive effect of sickness absence
timeFrame: Up to 31 months post baseline survey
measure: Health economic evaluation: self report
timeFrame: Up to 31 months post baseline survey
measure: Health economic evaluation: labour costs
timeFrame: 12 months post baseline survey
measure: Expectations to- and evaluation of treatment
timeFrame: Up to 31 months post baseline survey
measure: Barriers for return to work
timeFrame: Up to 31 months post baseline survey
measure: Motivation for work
timeFrame: Up to 31 months post baseline survey
measure: Effort/reward imbalance
timeFrame: Up to 31 months post baseline survey
measure: Workplace bullying
timeFrame: Up to 31 months post baseline survey
measure: Economic situation
timeFrame: Up to 31 months post baseline survey
measure: Procedural justice
timeFrame: Up to 31 months post baseline survey
measure: Relational justice
timeFrame: Up to 31 months post baseline survey
measure: Job phobia
timeFrame: Up to 31 months post baseline survey
measure: Ergonomic work environment
timeFrame: Up to 31 months post baseline survey
measure: Organisational change
timeFrame: Up to 31 months post baseline survey
measure: Work/family conflict
timeFrame: Up to 31 months post baseline survey
measure: Demand and control
timeFrame: Up to 31 months post baseline survey
Locations:
city: Bodø
country: Norway
facility: Helse I Arbeid Nordlandssykehuset
state: Nordland
city: Sandnessjøen
country: Norway
facility: Helse I Arbeid Helgelandssykehuset
state: Nordland
city: Alta
country: Norway
facility: Opptreningssenteret i Finnmark
state: Troms Og Finnmark
city: Kirkenes
country: Norway
facility: Helse I Arbeid Finnmarkssykehuset
state: Troms Og Finnmark
city: Tromsø
country: Norway
facility: Helse I Arbeid Universitetssykehuset Nord-Norge
state: Troms Og Finnmark
Study officials:
affiliation: UiT The Arctic University of Norway
name: Arnstein Mykletun, PhD
role: PRINCIPAL_INVESTIGATOR
References: