A Naturalistic Trial of the Norwegian Sickness Absence Clinic. The NSAC Efficacy Study

NCT05310695 | Active Not Recruiting

• 1 other identifier: 2019/1168-XX
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 5

Brief Summary

The Norwegian Sickness Absence Clinic (NSAC) is a publicly funded specialist outpatient health service, which is uniquely available for the work force. The overall aim of the NSAC is prevention of sickness absence, promote return to work (RTW) among those on sickness absence and prevent long term disability benefit dependency. In addition to being a health service, the NSAC has a focus on work and functional recovery, including also non-health related factors. Patients can be referred by general practitioners for mental health problems and musculoskeletal problems. The NSAC has a lower threshold for severity than specialist health services generally, and in particular for mental health problems. The efficacy of this service is unknown. The NSAC Efficacy Study is a randomized controlled multicentre trial which aims to assess the effect of the NSAC service. "Helse i Arbeid" is the Norwegian name for NSAC, and the Norwegian abbreviation is "HiA". The Norwegian study name is HIANOR. The NSAC Efficacy Study involves five different NSACs across northern Norway, and will recruit 2500 patients, randomized to in equal proportions to three treatment arms:

1. 1.NSAC - rapid: treatment at the NSAC at- or within 4 weeks
2. 2.NSAC - ordinary: treatment at the NSAC after 10-14 weeks
3. 3.NSAC - active control: monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval) The overall aim is to assess the effect of the NSAC service, with the hypothesis that the NSAC service is superior to what resembles treatment as usual (TAU) for outcomes such as return to work or improved health (waiting list control). Many of the diagnoses or problems for which patients are referred to the NSACs naturally improve regardless of health interventions, and - as of date - no research has been conducted to assess the efficacy of the service.

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

Outcome Measures

Primary Outcomes (7)

• Functional recovery: employment

  Employment during first 365 days post baseline survey, based on registry data and self-report.

  12 months post baseline survey

• Functional recovery: sickness absence

  Sickness absence during first 365 days post baseline survey, based on registry data and self-report.

  12 months post baseline survey

• Functional recovery: application for rehabilitation benefits

  Application for rehabilitation benefits during first 365 days post baseline survey, based on registry data and self-report.

  12 months post baseline survey

• Functional recovery: employment long term

  Employment during 5-and 10-year period post baseline survey, all based on registry data.

  5 and 10 years post baseline survey

• Functional recovery: sickness absence long term

  Sickness absence during 5-and 10-year period post baseline survey, all based on registry data.

  5 and 10 years post baseline survey

• Functional recovery: rehabilitation benefits long term

  Rehabilitation benefits during 5-and 10-year period post baseline survey, all based on registry data.

  5 and 10 years post baseline survey

• Functional recovery: disability benefits long term

  Disability benefits during 5-and 10-year period post baseline survey, all based on registry data.

  5 and 10 years post baseline survey

Secondary Outcomes (15)

• Mental health

  12 months post baseline survey

• Anxiety

  12 months post baseline survey

• Depressive symptoms

  12 months post baseline survey

• Sleep

  12 months post baseline survey

• Health Anxiety

  12 months post baseline survey

Other Outcomes (18)

• Preventive effect of sickness absence

  12 months post baseline survey

• Health care utilization

  At 12 and 60 months post first appointment at NSAC

• Health economic evaluation: self report EQ-5D

  12 months post baseline survey

Study Arms (3)

NSAC rapid: treatment at the NSAC at- or within 4 weeks

ACTIVE COMPARATOR

NSAC service delivered according to ordinary procedures, 4 weeks after referral.

Other: NSAC - rapid

NSAC ordinary: treatment at the NSAC after 10-14 weeks

ACTIVE COMPARATOR

NSAC service delivered according to ordinary procedures, 10-14 weeks after referral, by and large equivalent to current waiting time

Other: NSAC - ordinary

NSAC - active control

ACTIVE COMPARATOR

Monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval)

Other: NSAC - active control

Interventions

NSAC - ordinary OTHER

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 muskuloskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with a multi-diciplinary clarification or treatment of problems with the intent of improved function and return to work. Clinicians are provided survey information on the patients potential health problems, motivation for work, barriers for return to work and work environment prior to consultation. In this intervention arm, patients are offered treatment at 10-14 weeks after referral.

NSAC ordinary: treatment at the NSAC after 10-14 weeks

NSAC - rapid OTHER

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 muskuloskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with a multi-diciplinary clarification or treatment of problems with the intent of improved function and return to work. Clinicians are provided survey information on the patients potential health problems, motivation for work, barriers for return to work and work environment prior to consultation. In this intervention arm, patients are offered treatment within 4 weeks of referral.

NSAC rapid: treatment at the NSAC at- or within 4 weeks

NSAC - active control OTHER

The active control intervention is provided by the NSAC personnel, but patients are offered a single monodisciplinary examination close to the end of the diagnosis-specific deadline suggested in guidelines, which will vary between 8-26 weeks. Employment counsellors may not be involved in consultations, other cross-disciplinary consultations are restricted, and work-related factors are not to be focused on during examination. Clinicians are provided survey information only on the patient's potential health problems prior to consultation. Patients are provided a health-focused examination, with the aim of symptom-relief.

NSAC - active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* The patient must be considered eligible for treatment at the NSAC by the admission team at the NSAC.

You may not qualify if:

• Patients considered too healthy for treatment at the NSAC, i.e. not within target group
• Patients considered too sick for treatment at the NSAC, i.e. not within target group
• Patients that do not have a diagnosis that is relevant for treatment at the NSAC, i.e. not within target group
• Patients otherwise considered not within target group for the measure
• Patients which were included in the NSAC Nudge trial (clinicaltrials identifier: NCT05006976) may not be recruited within the first year of follow-up of that trial
• Patients which are secondary referred from other departments/clinics within the hospital
• Non-Norwegian or non-English speaking patients
• Patients which could not be reached by the research coordinator at the outpatient clinic for information about the study

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• University Hospital of North Norway: collaborator
• Helgeland Hospital Trust: collaborator
• Finnmarkssykehuset HF (Kirkenes, Norway): collaborator
• UiT The Arctic University of Norway: collaborator

Study Sites (5)

Helse I Arbeid Nordlandssykehuset

Bodø, Nordland, 8092, Norway

Location

Helse I Arbeid Helgelandssykehuset

Sandnessjøen, Nordland, 8800, Norway

Location

Helsepartner Rehabilitering Alta

Alta, Troms Og Finnmark, 9510, Norway

Location

Helse I Arbeid Finnmarkssykehuset

Kirkenes, Troms Og Finnmark, 9915, Norway

Location

Helse I Arbeid Universitetssykehuset Nord-Norge

Tromsø, Troms Og Finnmark, 9019, Norway

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Anxiety Disorders; Depression; Fatigue; Pain; Occupational Stress; Bullying

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Occupational Diseases; Stress, Psychological; Aggression; Harassment, Non-Sexual; Social Behavior

Study Officials

• Arnstein Mykletun, PhD

  UiT The Arctic University of Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized to either of three intervention arms:

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 5, 2022
• Study Start: January 16, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2034
• Last Updated: April 24, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)