No registrations found.
ID
Source
Brief title
Health condition
Traumatic Brain Injury
Traumatisch Hersenletsel
Sponsors and support
Hersenstichting
Intervention
Outcome measures
Primary outcome
Glasgow Outcome Scale Extended
Health-related Quality of Life
Secondary outcome
Physical functioning, Cognitive functioning, Depression, Aphasia, Disease Awareness, Fatigue, Activities, Participation, Employment Outcome, Healthcare Consumption, Costs
Background summary
Many acute and post-acute interventions for traumatic brain injury (TBI) are not evidence-based. Clinical practice is often too complex to be studied in clinical trials. Strict in- and exclusion criteria and selected treatment settings result in limited external validity. Large between-institution variation in process and structure of treatment may remain unnoticed leading to suboptimal patient outcomes. Comparative effectiveness research (CER) is a promising alternative to investigate the effectiveness of treatments in clinical practice. CER depends on high quality observational data, which are currently lacking in the Netherlands. Therefore development of a quality registry is a prerequisite to open the black box of the acute and post-acute treatment variety for TBI.
Study objective
Based on a new Neurotraumatology Quality Registry, best practices can be identified in the health care chain for patients with moderate and severe TBI
Study design
Hospital admission, Hospital discharge, Rehabilitation admission, Rehabilitation discharge, 6 months, 12 months, 24 months
Intervention
NA
MH Heijenbrok-Kal
[default]
The Netherlands
+31 10 2412412
mheijenbrok@rijndam.nl
MH Heijenbrok-Kal
[default]
The Netherlands
+31 10 2412412
mheijenbrok@rijndam.nl
Inclusion criteria
- Diagnosis of Traumatic Brain Injury
- GCS score < 13 at presentation at ER or =<24 hours after presentation at ER due to TBI
- Presentation at ER within 24 hours
- Age >= 16 years
Exclusion criteria
- Non-traumatic cause of reduced level of consciousness (cardiac or intoxication) at ER presentation
- Insufficient mastering of the Dutch or English language
- Serious (neurological) morbidity pre-injury which may interfere with TBI outcome
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5761 |
| NTR-old | NTR6003 |
| CCMO | NL50366.058.14 |
| OMON | NL-OMON46984 |