Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Traumatic Brain Injury With Brief Loss of Consciousness
• Interventions: Behavioral: primary care follow up; Behavioral: Multidisciplinary follow up

• Registration Number: NCT00869154
• Lead Sponsor: Haukeland University Hospital

Brief Summary

The aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor.

Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to and Prognostic factors in mild traumatic brain injury patients after discharge from hospital.

Detailed Description

2 months after an acute mild traumatic brain injury (TBI) defined as Glasgow Coma Scale between 13 and 15. The patient will get a clinical examination by a specialist in rehabilitation medicine. Patient who wish or need a further follow up, are out of work or school, will be included and randomized to either a multidisciplinary follow up or primary care follow by their family doctor.

Both groups will got a multidisciplinary examination. The multidisciplinary team will work out a rehabilitation program and a report back to their family doctor.

Patient who got a multidisciplinary follow up will then get individual appointments and they will follow an educational program for 4 days. The topics are physical and psychical problems after TBI and problems in daily living and return to work. We will teach a way to accept and deal with their problems. A cognitive behavioural treatment or a psycho educative approach will be central in the treatment. The follow up period will be until 2 years if needed.

For booth groups we will make a registration of sick leave for 5 years. The Extended Glasgow Outcome Scale (GOS- E), Hospital Anxiety and Depression Scale (HAD), Rivermead post concussion symptoms questionnaire and Patient Global Impression of Change (PGIC) after 6 and 12 months.

Department of Economics at the University of Bergen will make cost-benefit analysis.

Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to, if sick leave or return to work could make a difference and Prognostic factors in mild traumatic brain injury patients after discharge from hospital. We also include demographic data, CT findings and clinical data based on information from the medical records, pain drawings and numeric rating scale for pain, Quality of Life and Subjective Health Complaints inventory. We got data about days on sick leave, diagnosis for sick leave and income for the first year before and after the injury from The Norwegian Labour and Welfare Service (NAV) through a third accredited agency Statistics Norway. From Statistics Norway we got additional information about education level and income.

Study Timeline

• Study First Submitted: 2009-02-24
• Study Start: 2009-03-01
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2013-03-31
• Study Completion: 2015-03-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Patient admitted acute to Department of Neurosurgery ICD-10 diagnosed S06.0- S06.9
• Age 16 to 55 years
• Mild traumatic brain injury defined as Glasgow Coma Scale (GCS) between 13 and 15.

Exclusion Criteria

• Earlier severe traumatic brain injury (GCS 8 or less).
• Serious psychiatric disease (ICD-10 diagnosed last two years).
• Known drug abuse (ICD-10 diagnosed last two years).
• Other serious illness which have a major impact of the outcome.
• Social client last two years as major income

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary care follow up	primary care follow up	Multidisciplinary examination and follow up by the family doctor.
Multidisciplinary follow up	Multidisciplinary follow up	Multidisciplinary examination and follow up by a multidisciplinary outpatient team.

Primary Outcome Measures

Name	Time	Method
Return to work	6 and 12 months after 1. multidisciplinary examination	Sick leave for 5 years after injury

Secondary Outcome Measures

Name	Time	Method
GOSE	6 and 12 months after 1. multidisciplinary examination	Glasgow Outcome Scale Extended
Post-commotio symptoms (RPQ)	12 months	The Rivermead Post concussion symptoms Questionnaire
Patient's Global Impression of Change	12 months	Patient's Global Impression of Change

Trial Locations

Locations (2)

Haukeland University Hospital, Dept. physical medicine and rehabilitation; 🇳🇴 Bergen, Norway

Oslo University Hospital, Ullevål; 🇳🇴 Oslo, Norway