Expert@Work - Effectiveness of a Digital Expert Team on Return to Work

Sponsor
St. Olavs Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05575908
Collaborator
Norwegian Labour and Welfare Administration (Other)
170
4
2
46.6
42.5
0.9

Study Details

Study Description

Brief Summary

Long-term sick leave is a challenge in Norway, and the healthcare and labor- and welfare services are often not coordinated in helping the sick-listed employees return to work. In this study, the investigators want to evaluate the effectiveness of an intervention where an expert team provides advice for an individualized patient pathway based on information from a digital questionnaire and a video meeting with the sick-listed employee and the participant's general practitioner. The patient pathway should include both healthcare and labor- and welfare services measures.

Sick-listed patients with musculoskeletal- and/or common mental disorders are invited to join the study. They will receive a digital questionnaire and be randomized to either treatment as usual or personalized advice from an expert team. The team will be put together based on the response from the individual's questionnaire.

The investigators will evaluate the effect on return to work and the use of health care services 12 months after the intervention.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Digital expert team
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Sick-listed employees with musculoskeletal disorders and/or common mental disorders will receive an invitation to the study from the labor-and welfare administration. Individuals who consent to participate will be allocated to either treatment as usual or personalized advice from an expert-team.Sick-listed employees with musculoskeletal disorders and/or common mental disorders will receive an invitation to the study from the labor-and welfare administration. Individuals who consent to participate will be allocated to either treatment as usual or personalized advice from an expert-team.
Masking:
Single (Outcomes Assessor)
Masking Description:
It is not possible to blind the participants or the care providers. As the investigators also will be care providers in this study, they will also have knowledge of the allocation. After the intervention, all data will be depersonalized and the name and other identifiers will be replaced by a study number. The outcome will be collected from national registries and the merging of data will be done by a statistician in the labor- and welfare administration who is not involved in the assessment of data. This allows the researchers to be blinded when they analyze the data.
Primary Purpose:
Treatment
Official Title:
Expert@Work - Effectiveness of a Digital Expert Team on Return to Work
Actual Study Start Date :
Oct 13, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Digital expert team

The participants allocated to this arm will receive personalized advice from an expert team. The participants will have one video meeting with the team and receive a written report.

Procedure: Digital expert team
A digital team will be appointed based on the participant's answers in the digital screening questionnaire. Members of the team can be specialists in Physical and rehabilitation medicine, psychologist, physiotherapist, social workers, and consultants in the labor- and welfare administration. The general practitioner will also be invited to the meeting.

No Intervention: Treatment as usual

The participants will answer a digital questionnaire and will get normal follow-up from his/her general practitioner and labor- and welfare administration (NAV).

Outcome Measures

Primary Outcome Measures

  1. Return to work [12 months]

    Time to return to work within 12 months for at least 4 consecutive weeks

Secondary Outcome Measures

  1. Function [12 months]

    Approvement in function measured by Versus Arthritis Musculoskeletal Health Questionnaire (MSK-HQ). The MSK-HQ is scored on a range of 0-56, with a better score indicating better MSK-HQ health status

  2. Change in pain [12 months]

    Change in pain measured on a numeric rating scale (0-10), with a higher score indicating more pain

  3. Change in depression symptoms [12 months]

    Improvement in depression symptoms measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is scored on a range of 0-27, with higher score indicating more serious symptoms

  4. Change in anxiety symptoms [12 months]

    Improvement in anxiety symptoms measured by Generalized Anxiety Disorder 7-item (GAD-7). GAD-7 is scored on a range of 0-21, with higher score indicating more serious symptoms

  5. Days lost from work [12 months]

    Lost workdays during one year after intervention

Other Outcome Measures

  1. Sleep quality and insomnia [12 months]

    Prevalence of insomnia and bad sleep quality and change after 12 months. Measured with Insomnia severity index (ISI). ISI is scored on a range from 0-4, with higher score indicating more serious symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Sick-listed minimum 50% between 11 and 20 weeks

  • Musculoskeletal disorder and/or common mental disorder

  • Living in the county of Trøndelag or Møre- og Romsdal

Exclusion Criteria:
  • Specific conditions such as fracture, trauma, infections, malignancy, dislocations, etc.

  • Serious mental conditions or another serious disease that makes participation difficult

  • Most likely to return to work within 2 weeks

  • Not speaking/reading Norwegian

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sykehuset Levanger Levanger Midt-Norge Norway 7600
2 Molde Sjukehus Molde Midt-Norge Norway 6412
3 St. Olavs hospital HF Trondheim Midt-Norge Norway 7006
4 Ålesund sjukehus Ålesund Midt-Norge Norway 6017

Sponsors and Collaborators

  • St. Olavs Hospital
  • Norwegian Labour and Welfare Administration

Investigators

  • Study Director: Gunn Hege Marchand, PhD, St. Olavs hospital HF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT05575908
Other Study ID Numbers:
  • 2021/11991
First Posted:
Oct 12, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2022