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Trial record 1 of 1 for:    NCT02524392
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Effect Evaluation of Independent Medical Evaluation (IME) in Norway (NIME)

This study is currently recruiting participants.
Verified December 2015 by Uni Research
Sponsor:
ClinicalTrials.gov Identifier:
NCT02524392
First Posted: August 14, 2015
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
Uni Research
  Purpose
A randomized controlled trial comparing independent medical evaluation (IME) to treatment as usual (TAU). Participants will be individuals reaching six months uninterrupted sickness absence. Treatment as usual (TAU) is normal follow-up by a general practitioner (GP).

Condition Intervention
All International Classification of Primary Care 2 Diagnoses Other: Independent medical evaluation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect Evaluation of Independent Medical Evaluation (IME) After Six Months Sick Leave: A Randomized Controlled Trial of Independent Medical Evaluation (IME) Versus Treatment as Usual in Norway

Further study details as provided by Uni Research:

Primary Outcome Measures:
  • Change in sick leave [ Time Frame: Measured at three and eight weeks after randomization. ]
    Data on sickness benefits from official registers will be used to measure the primary outcome.


Estimated Enrollment: 3784
Study Start Date: September 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Independent medical evaluation
Independent medical evaluation (IME) of another doctor than the treating general practitioner.
Other: Independent medical evaluation
The independent medical evaluation (IME) will be performed by specialists in general medicine, temporarily hired by the county welfare service. The independent medical evaluation (IME) procedure is developed by the Research Unit for General Practice at Uni Research Health in Norway.
No Intervention: Treatment as usual
Treatment as usual by the treating general practitioner. There will be one randomized control group in one county. Sick-listed in other counties serve as an extra control group.

Detailed Description:
A randomized controlled trial in a Norwegian context, involving an effect evaluation, a cost-benefit evaluation and a qualitative evaluation. Independent medical evaluation (IME) will be compared to treatment as usual (TAU). Independent medical evaluation (IME) will comprise a consultation with an independent general practitioner (IME GP) who will assess whether the sick listed worker has been given eligible and available opportunities in return to work follow-up in Norway. The independent medical evaluation general practitioner (IME GP) will write a short report that is sent to the treating general practitioner as input from a colleague. The report can be used in the follow-up of the sick listed participant. The participants in the treatment as usual (TAU) group will not receive any other follow-up than normal follow-up by the treating general practitioner. The qualitative evaluation will be conducted to gain insight into the experiences of the general practitioners and the participants.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants on sick leave with an International Classification of Primary Care-2 diagnosis will be recruited through the Norwegian Labour and Welfare Administration's (NAV) registries, when reaching 22 weeks of sick leave (full or graded).

Exclusion Criteria:

  • People with International Classification of Disease-10 diagnoses, cancer or dementia.
  • People who are pregnant.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524392


Contacts
Contact: Silje Maeland, PhD silje.maeland@uni.no

Locations
Norway
Uni Research Recruiting
Bergen, Norway, 5014
Contact: Silje Maeland, PhD       silje.maeland@uni.no   
Sponsors and Collaborators
Uni Research
Norwegian Labour and Welfare Administration
Investigators
Principal Investigator: Silje Maeland, PhD Uni Research Health
  More Information

Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT02524392     History of Changes
Other Study ID Numbers: UniResearch
First Submitted: June 23, 2015
First Posted: August 14, 2015
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Uni Research:
independent medical evaluation
sick leave
sickness absence
physician primary care
general practitioner
family physician


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