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Completed

NCT Number: NCT02524392

Effect Evaluation of Independent Medical Evaluation (IME) in Norway

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).

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Key information

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uni Research

Bergen, 5014, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Independent medical evaluation

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Collaborators

  • Norwegian Labour and Welfare Administration

Registry information

Official study 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

Acronym: NIME

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2015
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.