NCT02524392

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,642

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2.4 years

First QC Date

June 23, 2015

Last Update Submit

May 9, 2018

Conditions

All International Classification of Primary Care 2 Diagnoses

Keywords

independent medical evaluationsick leavesickness absencephysician primary caregeneral practitionerfamily physician

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Independent medical evaluation

EXPERIMENTAL

Independent medical evaluation (IME) of another doctor than the treating general practitioner.

Other: Independent medical evaluation

Treatment as usual

NO INTERVENTION

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.

Interventions

Independent medical evaluationOTHER

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.

Independent medical evaluation

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • People with International Classification of Disease-10 diagnoses, cancer or dementia.
  • People who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uni Research

Bergen, 5014, Norway

Location

Related Publications (4)

  • Maeland S, Holmas TH, Oyeflaten I, Husabo E, Werner EL, Monstad K. What is the effect of independent medical evaluation on days on sickness benefits for long-term sick listed employees in Norway? A pragmatic randomised controlled trial, the NIME-trial. BMC Public Health. 2022 Feb 26;22(1):400. doi: 10.1186/s12889-022-12800-1.

    PMID: 35216560DERIVED

  • Oyeflaten I, Maeland S, Haukenes I. Independent medical evaluation of general practitioners' follow-up of sick-listed patients: a cross-sectional study in Norway. BMJ Open. 2020 Mar 18;10(3):e032776. doi: 10.1136/bmjopen-2019-032776.

    PMID: 32193258DERIVED

  • Aamland A, Husabo E, Maeland S. Independent medical evaluation for sick-listed patients: a focus group study of GPs expectations and experiences. BMC Health Serv Res. 2018 Aug 29;18(1):666. doi: 10.1186/s12913-018-3481-3.

    PMID: 30157844DERIVED

  • Husabo E, Monstad K, Holmas TH, Oyeflaten I, Werner EL, Maeland S. Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway. BMC Public Health. 2017 Jun 14;17(1):573. doi: 10.1186/s12889-017-4469-3.

    PMID: 28615017DERIVED

MeSH Terms

Interventions

Independent Medical Evaluation

Intervention Hierarchy (Ancestors)

Health Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Silje Maeland, PhD

    Uni Research Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

August 14, 2015

Study Start

September 1, 2015

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

NO(1)