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

Sponsor
Nordlandssykehuset HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT05006976
Collaborator
University Hospital of North Norway (Other), Opptreningssenteret i Finnmark (Alta, Norway) (Other), Helgelandssykehuset HF (Other), Finnmarkssykehuset HF (Kirkenes, Norway) (Other), UiT The Arctic University of Norway (Other)
800
Enrollment
5
Locations
2
Arms
66.8
Anticipated Duration (Months)
160
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

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 800 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 800 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Nudging Clinicians to Think Beyond Health in the Norwegian Sickness Absence Clinic. The NSAC Nudge Trial
Actual Study Start Date :
Sep 6, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2027

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: 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.

Other: NSAC health only
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.

Experimental: 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.

Other: NSAC health + MBW
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Functional recovery: sickness absence self-report [12 months post first appointment at NSAC]

    Employment, sickness absence and application for rehabilitation benefits during first 365 days post first treatment at the NSAC, based on patient self-report.

  3. Functional recovery: sickness absence registry data [12 months post first appointment at NSAC]

    Employment, sickness absence and application for rehabilitation benefits during first 365 days post first treatment at the NSAC, based on registry data.

  4. Functional recovery: disability benefits [60 months post first appointment at NSAC]

    Employment, sickness absence, rehabilitation benefits and disability benefits during 5-year period post first treatment at the NSAC, all based on registry data.

Secondary Outcome Measures

  1. Mental health [12 months post first appointment at NSAC]

    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).

  2. Anxiety [12 months post first appointment at NSAC]

    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

  3. Depressive symptoms [12 months post first appointment at NSAC]

    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

  4. Sleep [12 months post first appointment at NSAC]

    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.

  5. Health Anxiety [12 months post first appointment at NSAC]

    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

  6. Subjective health complaints [12 months post first appointment at NSAC]

    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.

  7. Back pain [12 months post first appointment at NSAC]

    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.

  8. Neck pain [12 months post first appointment at NSAC]

    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.

  9. Pain intensity [12 months post first appointment at NSAC]

    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.

  10. Fear avoidance [12 months post first appointment at NSAC]

    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.

  11. Physical activity [12 months post first appointment at NSAC]

    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. Fatigue [12 months post first appointment at NSAC]

    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

  13. Pain localization [12 months post first appointment at NSAC]

    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.

  14. Cause of pain [12 months post first appointment at NSAC]

    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.

  15. Self-reported diagnoses [12 months post first appointment at NSAC]

    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.

Other Outcome Measures

  1. Preventive effect of sickness absence [12 months post first appointment at NSAC]

    Changes in self-reported beliefs about the potential preventive effect of short-term sickness absence on long term sickness absence between prior to first treatment and 6- and 12 months post first treatment. The respondent is asked whether he/she agrees to 5 different statements on this topic, using a 5-point likert scale.

  2. Health economic evaluation: self report [12 months post first appointment at NSAC]

    Health economic evaluation is measured using the EQ-5D and the ReQol instruments, issued to patients prior to first treatment and 6- and 12 months post first treatment to assess change.

  3. Health economic evaluation: labour costs [12 months post first appointment at NSAC]

    Health economic evaluation also involves data on number of professions seeing the patient and number of working hours spent on the patient by each profession seeing the patient during the treatment period, recorded in questionnaires filled out by the clinicians after each consultation. This enables calculation of costs in terms of manpower and staff.

  4. Expectations to- and evaluation of treatment [12 months post first appointment at NSAC]

    Using open-ended questions, patients are asked about their expectations towards treatment prior to first treatment, and about their evaluation of treatment 6- and 12 months first treatment. These two will be compared.

  5. Barriers for return to work [12 months post first appointment at NSAC]

    Changes in self-reported barriers for return to work between prior to first treatment and 6- and 12 months post first treatment. The questionnaire includes 26 items concerning barriers for return to work and is part of the survey in the MBW intervention.

  6. Motivation for work [12 months post first appointment at NSAC]

    Changes in self-reported motivation for work between prior to first treatment and 6- and 12 months post first treatment. The questionnaire consists of a number of questions concerning motivation, and is part of the survey in the MBW intervention.

  7. Effort/reward imbalance [12 months post first appointment at NSAC]

    Changes in self-reported effort/reward imbalance between prior to first treatment and 6- and 12 months post first treatment. Effort/reward imbalance is part of the survey in the MBW intervention, and is measured using the 3 items with the highest factor loading in the Siegrist Effort/Reward Imbalance Questionnaire (short version). A high score on either of the three items triggers the rest of the questionnaire.

  8. Workplace bullying [12 months post first appointment at NSAC]

    Changes in self-reported workplace bullying between prior to first treatment and 6- and 12 months post first treatment. Workplace bullying is measured using the Short Negative Acts Questionnaire (SNAQ).

  9. Economic situation [12 months post first appointment at NSAC]

    Changes in self-reported economic situation between prior to first treatment and 6- and 12 months post first treatment. The questionnaire includes 2 items concerning economic problems and concerns about economic problems.

  10. Procedural justice [12 months post first appointment at NSAC]

    Changes in self-reported procedural justice between prior to first treatment and 6- and 12 months post first treatment. Procedural justice is part of the survey in the MBW intervention, and is measured by 3 items concerning workplace decisions.

  11. Relational justice [12 months post first appointment at NSAC]

    Changes in self-reported relational justice between prior to first treatment and 6- and 12 months post first treatment. Relational justice is part of the survey in the MBW intervention, and is measured by 4 items concerning the general behaviour of the respondent's supervisor.

  12. Job phobia [12 months post first appointment at NSAC]

    Changes in self-reported job phobias between prior to first treatment and 6- and 12 months post first treatment. Job phobia is measured by 12 items concerning the respondent's avoidance of the workplace or work-related anxiety.

  13. Ergonomic work environment [12 months post first appointment at NSAC]

    Changes in self-reported ergonomic work environment between prior to first treatment and 6- and 12 months post first treatment. Ergonomic work environment is measured by 11 items concerning the respondent's physical tasks at work.

  14. Organisational change [12 months post first appointment at NSAC]

    Changes in self-reported organisational change between prior to first treatment and 6- and 12 months post first treatment l. Organisational change is part of the survey in the MBW intervention, and is measured using the 3 items covering changes in management, colleagues and tasks.

  15. Work/family conflict [12 months post first appointment at NSAC]

    Changes in self-reported work/family conflict between prior to first treatment and 6- and 12 months post first treatment. Work/family conflict is part of the survey in the MBW intervention, and is measured using the 4 items with the highest factor loading in the Home-Work Interference Scale.

  16. Demand and control [12 months post first appointment at NSAC]

    Changes in self-reported demand and control between prior to first treatment and 6- and 12 months post first treatment. Demand and control is measured using three questions from the instrument developed by Karasek/Theorell, and is part of the survey in the MBW intervention. A high score on either of the three items triggers the rest of the questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Helse I Arbeid NordlandssykehusetBodøNordlandNorway8092
2Helse I Arbeid HelgelandssykehusetSandnessjøenNordlandNorway8800
3Opptreningssenteret i FinnmarkAltaTroms Og FinnmarkNorway9510
4Helse I Arbeid FinnmarkssykehusetKirkenesTroms Og FinnmarkNorway9915
5Helse I Arbeid Universitetssykehuset Nord-NorgeTromsøTroms Og FinnmarkNorway9019

Sponsors and Collaborators

  • Nordlandssykehuset HF
  • University Hospital of North Norway
  • Opptreningssenteret i Finnmark (Alta, Norway)
  • Helgelandssykehuset HF
  • Finnmarkssykehuset HF (Kirkenes, Norway)
  • UiT The Arctic University of Norway

Investigators

  • Principal Investigator: Arnstein Mykletun, PhD, UiT The Arctic University of Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nordlandssykehuset HF
ClinicalTrials.gov Identifier:
NCT05006976
Other Study ID Numbers:
  • NSAC Nudge
First Posted:
Aug 16, 2021
Last Update Posted:
Mar 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nordlandssykehuset HF
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022