All International Classification of Primary Care 2 DiagnosesNIMENCT02524392
Effect Evaluation of Independent Medical Evaluation (IME) in Norway
A study testing Independent medical evaluation in people with All International Classification of Primary Care 2 Diagnoses, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- All International Classification of Primary Care 2 Diagnoses
- What is being tested?
- Independent medical evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,642 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- People with International Classification of Disease-10 diagnoses, cancer or dementia.
- People who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- Independent medical evaluation
- Keywords
- independent medical evaluation, sick leave, sickness absence, physician primary care, general practitioner, family physician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Independent medical evaluation | Experimental | Independent medical evaluation (IME) of another doctor than the treating general practitioner. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sick leave
Data on sickness benefits from official registers will be used to measure the primary outcome.
Measured: Measured at three and eight weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for All International Classification of Primary Care 2 DiagnosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,642 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
- Investigators
- Silje Maeland, PhD, Principal investigator, Uni Research Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524392
- Sponsor's protocol ID
- UniResearch
- Acronym
- NIME
- Status last verified
- May 2018
- First submitted
- 23 Jun 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35216560Oyeflaten 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.
PubMed 32193258Aamland 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.
PubMed 30157844Husabo 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.
PubMed 28615017
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02524392
- Acronym / sponsor ID
- NIME / UniResearch
- Keywords
- independent medical evaluation, sick leave, sickness absence, physician primary care, general practitioner, family physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,642 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- Sep 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Independent medical evaluation | Experimental | Other: Independent medical evaluationIndependent medical evaluation (IME) of another doctor than the treating general practitioner. |
| 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. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- People with International Classification of Disease-10 diagnoses, cancer or dementia.
- People who are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Independent medical evaluationThe 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. | Other | Independent medical evaluation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 35216560Maeland 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.
- Derived from this study: PubMed 32193258Oyeflaten 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.
- Derived from this study: PubMed 30157844Aamland 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.
- Derived from this study: PubMed 28615017Husabo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silje Maeland, PhD principal investigator
Uni Research Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Independent medical evaluation in people with All International Classification of Primary Care 2 Diagnoses, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sick leave (time frame: Measured at three and eight weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524392, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.