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Brain Trauma Outcomes in Nova Scotia Study (BTOS)

Primary Purpose

Brain Injuries,Traumatic, Outcome Assessment (Health Care), Craniocerebral Trauma

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Head Injury Guideline

About this trial

This is an interventional health services research trial for Brain Injuries,Traumatic focused on measuring Brain Injury, Head Trauma, Trauma Systems, Head Injury Guideline, Time to Tertiary Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Retrospective Arm Cohort 1: AIS ≥ 3, head +/- other injuries Cohort 2: AIS ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1)

Inclusion Criteria:

1.patient treated in at least one facility prior to arrival at QEII.

Exclusion Criteria

injured out of province
time from injury to 1st facility presentation known to be > 24 hours
time arrival at 1st referring facility to time arrive at QEII known to be > 24 hours
direct ground or air scene transport

Prospective Arm:

Inclusion Criteria:

have a head injury requiring hospital admission
able to provide informed consent or have next- of -kin able to provide consent on patients' behalf

Exclusion Criteria:

1. unwilling or unable to provide consent

Sites / Locations

Outcomes

Primary Outcome Measures

Time Measurement; Hours:minutes

Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care

Secondary Outcome Measures

Clinical Follow-up; Numerical Score 1-5;Glasgow Outcome Scores (GOS)

Glasgow Outcome Scores (GOS) Score ranges from: 5 Good Recovery (Resumption of normal life despite minor deficits) 4 Moderate Disability(Disabled but independent. Can work in sheltered setting) 3 Severe Disability (Conscious but disabled. Dependent for daily support) 2 Persistent vegetative (Minimal responsiveness) 1 Death (Non survival)

Full Information

NCT ID

NCT01225692

First Posted

October 15, 2010

Last Updated

October 20, 2010

Sponsor

Queen Elizabeth II Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT01225692

Brief Title

Brain Trauma Outcomes in Nova Scotia Study

Acronym

BTOS

Official Title

Brain Trauma Outcomes in Nova Scotia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Queen Elizabeth II Health Sciences Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma. Retrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication. Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries,Traumatic, Outcome Assessment (Health Care), Craniocerebral Trauma, Emergency Medical Services, Organizational Innovation

Keywords

Brain Injury, Head Trauma, Trauma Systems, Head Injury Guideline, Time to Tertiary Care

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Head Injury Guideline

Primary Outcome Measure Information:

Title

Time Measurement; Hours:minutes

Description

Time as measured by ; Time Elapsed from Injury Time to Time of Arrival at Tertiary Care

Secondary Outcome Measure Information:

Title

Clinical Follow-up; Numerical Score 1-5;Glasgow Outcome Scores (GOS)

Description

10. Eligibility

Sex

All

Eligibility Criteria

Retrospective Arm Cohort 1: AIS ≥ 3, head +/- other injuries Cohort 2: AIS ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1) Inclusion Criteria: 1.patient treated in at least one facility prior to arrival at QEII. Exclusion Criteria injured out of province time from injury to 1st facility presentation known to be > 24 hours time arrival at 1st referring facility to time arrive at QEII known to be > 24 hours direct ground or air scene transport Prospective Arm: Inclusion Criteria: have a head injury requiring hospital admission able to provide informed consent or have next- of -kin able to provide consent on patients' behalf Exclusion Criteria: 1. unwilling or unable to provide consent

12. IPD Sharing Statement

Learn more about this trial

Brain Trauma Outcomes in Nova Scotia Study

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