Effect Evaluation of Independent Medical Evaluation (IME) in Norway

All International Classification of Primary Care 2 Diagnoses Clinical Trial

— NIME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524392
• Other study ID #: UniResearch
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: Uni Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7642
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• All International Classification of Primary Care 2 Diagnoses

Intervention

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.

Locations

Country	Name	City	State
Norway	Uni Research	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Uni Research	Norwegian Labour and Welfare Administration

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sick leave	Data on sickness benefits from official registers will be used to measure the primary outcome.	Measured at three and eight weeks after randomization.