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

Sponsor
Nordlandssykehuset HF (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05310695
Collaborator
University Hospital of North Norway (Other), Helsepartner Rehabilitering AS (Alta, Norway) (Other), Helgelandssykehuset HF (Other), Finnmarkssykehuset HF (Kirkenes, Norway) (Other), UiT The Arctic University of Norway (Other)
2,500
3
86

Study Details

Study Description

Brief Summary

The Norwegian Sickness Absence Clinic (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, abbreviation HiA.

The NSAC Efficacy Study involves five different NSACs across northern Norway, and will invite 2500 patients, randomized to either of three treatment arms:

  1. NSAC - rapid: treatment at the NSAC after 4 weeks

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

  3. NSAC - waiting list control: treatment at the NSAC after 52 weeks

The overall aim is to assess the effect of the NSAC service, with the hypothesis that the NSAC service is superior to not receiving treatment 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.

Condition or Disease Intervention/Treatment Phase
  • Other: NSAC - rapid
  • Other: NSAC - ordinary
  • Other: NSAC - waiting list control
N/A

Detailed Description

The NSAC Efficacy Study is part of a broader project, the Norwegian Sickness Absence Clinic Study (NSACS). The NSACS currently has two sources of funding: Northern Norway Regional

Health Authority and The Norwegian Labour and Welfare Administration and involves two RCTs:

NSAC Efficacy and NSAC Nudge and fifteen work packages covering various topics. The randomized controlled trial NSAC Efficacy is the subject of this trial registration.

The NSAC Efficacy Study is a naturalistic randomized controlled multicentre trial, carried out in northern Norway and involving five NSACs. The study invites 2500 patients, randomized to either of three treatment arms:

  1. NSAC rapid: treatment at the NSAC after 4 weeks

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

  3. NSAC waiting list control: treatment at the NSAC after 52 weeks

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 electronic survey about their health, and work conditions, motivation for work and barriers for return to work (RTW). The survey tool manages the randomization.

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 (data on number of treatments, diagnosis, professions involved, and types of treatment provided).

The patient questionnaire covers 9 themes, split in two sections. Section 1 covers health, and includes musculoskeletal problems, mental health, and other health related issues (such as alcohol consumption, medication, and physical activity). Section 2 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 (such as the EQ-5D) and expectations for treatment.

By and large the questionnaire consists of test batteries which have been validated for specific topics. 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 at before first treatment and at 6- and 12 months after first treatment. In addition, before treatments, patients will be given shorter versions of the same questionnaire to be filled out at the clinic. These shorter questionnaires will consist of questions to which the patient at baseline indicated a high score, and thus includes more relevant information to the clinician.

In the NSAC Efficacy Study, receiving treatment at NSACs presupposes consent to participate in research, as the effect of the treatment is as of date unknown. Hence, receiving treatment at the NSAC is not necessarily superior to other available health services. Other available health services that may be utilized by patients serving in the control groups include mono-disciplinary treatment by physiotherapists, psychologists, general practitioners, gyms, electronically delivered self-help tools etc. All patients referred to NSACs will be offered treatment, but patients that decline to participate in research are provided with the service after a 52-week waiting period (same as randomization arm #3).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients are randomized to either of three intervention arms:Patients are randomized to either of three intervention arms:
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Naturalistic Efficacy Trial of the Norwegian Sickness Absence Clinic for Patients With Common Mental Disorder and Musculoskeletal Disorders
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: NSAC - rapid

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

Other: NSAC - rapid
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.

Active Comparator: NSAC - ordinary

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

Other: NSAC - ordinary
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.

Other: NSAC - waiting list control

NSAC service delivered according to ordinary procedures, 52 weeks after referral, thus serving as waiting list control. Patients have full access to treatment as usual (TAU) during waiting period.

Other: NSAC - waiting list control
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 52 weeks after referral, but may seek other health care services during the waiting period.

Outcome Measures

Primary Outcome Measures

  1. Functional recovery: employment [1.5 years post referral]

    Employment during first 365 days post first treatment at the NSAC, based on registry data and self-report.

  2. Functional recovery: sickness absence [1.5 years post referral]

    Sickness absence during first 365 days post first treatment at the NSAC, based on registry data and self-report.

  3. Functional recovery: application for rehabilitation benefits [1.5 years post referral]

    Application for rehabilitation benefits during first 365 days post first treatment at the NSAC, based on registry data and self-report.

  4. Functional recovery: employment long term [5.5- and 10.5 years post referral]

    Employment during 5-and 10-year period post first treatment at the NSAC, all based on registry data.

  5. Functional recovery: sickness absence long term [5.5- and 10.5 years post referral]

    Sickness absence during 5-and 10-year period post first treatment at the NSAC, all based on registry data.

  6. Functional recovery: rehabilitation benefits long term [5.5- and 10.5 years post referral]

    Rehabilitation benefits during 5-and 10-year period post first treatment at the NSAC, all based on registry data.

  7. Functional recovery: disability benefits long term [5.5- and 10.5 years post referral]

    Disability benefits during 5-and 10-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 diagnosis [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 EQ-5D [12 months post first appointment at NSAC]

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

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

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

  4. Health economic evaluation: labour costs [Time Frame: 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.

  5. 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.

  6. 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.

  7. 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.

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

    Changes in self-reported effort/reward imbalance (ERI) between prior to first treatment and 6- and 12 months post first treatment. ERI 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.

  9. 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).

  10. 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.

  11. 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. It is measured by 3 items concerning workplace decisions.

  12. 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 measured by 4 items concerning the general behaviour of the respondent's supervisor.

  13. 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.

  14. 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.

  15. 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. Organisational change is measured using the 3 items covering changes in management, colleagues and tasks.

  16. 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 measured using the 4 items with the highest factor loading in the Home-Work Interference Scale.

  17. 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. A high score on either of the three items triggers the rest of the questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The patient must be considered eligible for treatment at the NSAC by the admission team at the NSAC.
Exclusion Criteria:
  • Patients aged 23 years or less at the time of referral.

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Nordlandssykehuset HF
  • University Hospital of North Norway
  • Helsepartner Rehabilitering AS (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:
NCT05310695
Other Study ID Numbers:
  • 2019/1168-XX
First Posted:
Apr 5, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 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 Aug 17, 2022