Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Effect of Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury With Brief Loss of Consciousness
• Intervention / Treatment: Behavioral: primary care follow up; Behavioral: Multidisciplinary follow up

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, N-5020
    • Haukeland University Hospital, Dept. physical medicine and rehabilitation
  • Oslo, Norway, N-0407
    • Oslo University Hospital, Ullevål

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Primary care follow up; Multidisciplinary examination and follow up by the family doctor.	Behavioral: primary care follow up; Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.; Other Names: Bergen Mild Traumatic Brain Injury Study.
Experimental: Multidisciplinary follow up; Multidisciplinary examination and follow up by a multidisciplinary outpatient team.	Behavioral: Multidisciplinary follow up; Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.; Other Names: Bergen Mild Traumatic Brain Injury Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to work	Sick leave for 5 years after injury	6 and 12 months after 1. multidisciplinary examination

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Ullevaal University Hospital; Stiftelsen Helse og Rehabilitering
• Investigators: Study Director: Jan Sture Skouen, MD, PhD, Haukeland University Hospital

Publications and helpful links

Helpful Links

• Publications from the project: Multidisciplinary outpatient treatment in patients with mild traumatic brain injury: A randomised controlled intervention study.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2009
• Primary Completion (Actual): March 31, 2013
• Study Completion (Actual): March 31, 2015

Study Registration Dates

• First Submitted: February 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 25, 2009

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Injury, Brain, Traumatic; TBI (Traumatic Brain Injury); Brain Injuries, Traumatic; Mild TBI; Injuries, Acute Brain; Acute Brain Injuries
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Consciousness Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Unconsciousness; Brain Concussion
• Other Study ID Numbers: NSD 20425