A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study

Study Overview
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Brief Summary
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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
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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. 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 work conditions, motivation for work and barriers for Return to Work (RTW) 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 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 Motivation for work, Barriers for RTW and Work environment (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, and at 6- and 12 months after first treatment. 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.

Official Title
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Nudging Clinicians to Think Beyond Health in the Norwegian Sickness Absence Clinic. The NSAC Nudge Trial

Conditions
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Musculoskeletal Disorder, Anxiety Disorders, Depression, Fatigue, Pain, Occupational Exposure, Work Related Stress, Workplace Bullying, Employment, Sickness Absence, Return to Work

Intervention / Treatment
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* Other: NSAC health only
* Other: NSAC health + MBW


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSAC health only<br>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. | Other: NSAC health only<br>* NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In NSAC health only, clinicians are provided survey information on potential health problems only.<br>|
| Experimental: NSAC health + MBW<br>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. | Other: NSAC health + MBW<br>* NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In NSAC health + MBW clinicians are provided survey information on potential health problems as well as information on motivation for work, barriers for return to work and work environment factors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional recovery: status, plan and prognosis for employment versus sickness absence | 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. | At last appointment at NSAC (can vary substantially between patients, but generally < 3 months after first appointment at NSAC) | 
| Functional recovery: sickness absence self-report | Employment, sickness absence and application for rehabilitation benefits during first 365 days post first treatment at the NSAC, based on patient self-report. | 12 months post first appointment at NSAC | 
| Functional recovery: sickness absence registry data | Employment, sickness absence and application for rehabilitation benefits during first 365 days post first treatment at the NSAC, based on registry data. | 12 months post first appointment at NSAC | 
| Functional recovery: disability benefits | Employment, sickness absence, rehabilitation benefits and disability benefits during 5-year period post first treatment at the NSAC, all based on registry data. | 60 months post first appointment at NSAC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental health | Changes in self-reported mental health between prior to first treatment and 6- and 12 months post first treatment, measured using the Hopkins Symptoms Checklist - 10 (HSCL-10). | 12 months post first appointment at NSAC | 
| Anxiety | Changes in self-reported anxiety between prior to first treatment and 6- and 12 months post first treatment, measured using the Beck Anxiety Inventory (BAI). The instrument is provided to patients upon indication, defined as a HSCL-10 score > 1.4 | 12 months post first appointment at NSAC | 
| Depressive symptoms | Changes in self-reported depression between prior to first treatment and 6- and 12 months post first treatment, measured using the Beck Depression Inventory (BDI). The instrument is provided to patients upon indication, defined as a HSCL-10 score > 1.4 | 12 months post first appointment at NSAC | 
| Sleep | Changes in self-reported sleep between prior to first treatment and 6- and 12 months post first treatment, measured using 3 questions commonly used to diagnose sleeping disorder according to the DSM-IV criteria for insomnia. | 12 months post first appointment at NSAC | 
| Health Anxiety | Changes in self-reported health anxiety between prior to first treatment and 6- and 12 months post first treatment, 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 | 12 months post first appointment at NSAC | 
| Subjective health complaints | Changes in subjective health between prior to first treatment and 6- and 12 months post first treatment, measured using a modified version of the Ursin Health Inventory. | 12 months post first appointment at NSAC | 
| Back pain | Changes in self-reported back pain between prior to first treatment and 6- and 12 months post first treatment, 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. | 12 months post first appointment at NSAC | 
| Neck pain | Changes in self-reported neck pain between prior to first treatment and 6- and 12 months post first treatment, 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. | 12 months post first appointment at NSAC | 
| Pain intensity | Changes in self-reported pain intensity between prior to first treatment and 6- and 12 months post first treatment, 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. | 12 months post first appointment at NSAC | 
| Fear avoidance | Changes in self-reported fear avoidance between prior to first treatment and 6- and 12 months post first treatment, 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. | 12 months post first appointment at NSAC | 
| Physical activity | Changes in self-reported level of physical between prior to first treatment and 6- and 12 months post first treatment, measured using the Saltin-Grimby Physical Activity Level Scale (SGPALS). | 12 months post first appointment at NSAC | 
| Fatigue | Changes in self-reported fatigue between prior to first treatment and 6- and 12 months post first treatment, 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 | 12 months post first appointment at NSAC | 
| Pain localization | Changes in self-reported localization of pain between prior to first treatment and 6- and 12 months post first treatment. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on localization of pain. | 12 months post first appointment at NSAC | 
| Cause of pain | Changes in self-reported cause of pain between prior to first treatment and 6- and 12 months post first treatment. All patients are asked whether they suffer from musculoskeletal pain, and if present, they are provided questions on the believed cause of pain. | 12 months post first appointment at NSAC | 
| Self-reported diagnoses | Changes in self-reported diagnoses between prior to first treatment and 6- and 12 months post first treatment. 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. | 12 months post first appointment at NSAC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Return to work, Sickness absence, Nudge, Barriers for return to work, Motivation for work, Demand and control, Work/family conflict, Bullying