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SWIFT Study in the ED (SWIFT)

Primary Purpose

Mild Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SWIFT
SWIFT-Acute
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion criteria are based on the World Health Organization definition of mTBI. For inclusion in the study, participants must meet following criteria:

  1. At least 18 years of age and English speakers
  2. Present to ED with mechanism of trauma to the head, non-penetrating injury, or recent history of trauma to the head
  3. Glasgow Coma Scale score of 13-15 after 30 minutes post injury or later upon presentation for healthcare
  4. Discharged from the ED in <48 hours from time of admission
  5. In addition participants must have one or more of the following symptoms at time of injury:

    1. confusion or disorientation
    2. loss of consciousness for 30 minutes or less,
    3. post-traumatic amnesia for less than 24 hours
    4. other transient neurological abnormalities such as focal signs, seizure and intracranial lesion not requiring surgery

Exclusion Criteria:

  1. the manifestations of mTBI are determined to be caused by penetrating craniocerebral injury
  2. patients <18 years of age or non-English speaking
  3. patients with intracranial lesion requiring surgery
  4. patients admitted to the hospital from ED
  5. patients in police custody
  6. patients without a telephone contact number

Sites / Locations

  • UCSF San Francisco General Hospital and Trauma CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SWIFT: Acute Social Work Intervention in the ED and Follow Up

SWIFT-Acute Only: Acute social work intervention in the ED

Arm Description

Participants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT).

acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)

Outcomes

Primary Outcome Measures

Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ)

Secondary Outcome Measures

Change in Headache Impact Test (HIT-6)
Change in Insomnia Severity Index (ISI)
Change in The Post Traumatic Stress Disorder Checklist (PCL-C)
Change in Cornell Service Index
Change in The Alcohol Use Disorders Identification Test (AUDIT)
Change in Community Integration Questionnaire (CIQ)
Change in Patient Health Questionnaire (PHQ)-9
Change in Generalized Anxiety Disorder (GAD)-7

Full Information

First Posted
June 28, 2013
Last Updated
April 25, 2016
Sponsor
University of Washington
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01893970
Brief Title
SWIFT Study in the ED
Acronym
SWIFT
Official Title
Social Work Intervention for Adults With Mild Traumatic Brain Injury: SWIFT Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mild traumatic brain injury (mTBI) is a prevalent and costly public health problem with disabling consequences. More than one million civilians with mTBI are treated in US hospitals and emergency departments each year (Faul, et al., 2010). While the exact number is debated, approximately 10-15% of individuals with mTBI will experience prolonged and disabling post-concussive symptoms (Stranjalis, et al., 2008; Ruff and Weyer Jamora, 2009), and 34% will experience a psychiatric illness in the first year after injury (Fann, et al., 2004). In addition, at least 188,270 military service members sustained a TBI from 2000 to mid August 2010, and nearly 77% of these injuries were mild (Defense and Veterans Brain Injury Center, 2010). Many individuals require treatment for resulting mTBI symptoms. The proposed study builds on preliminary research conducted by the investigators to develop and test the effectiveness of a social work delivered education and reassurance intervention for adults with mTBI (SWIFT-Acute) against usual care. The proposed study will assess acceptability and obtain preliminary effectiveness data for an enhanced social work assessment and intervention for adults with mTBI (SWIFT) discharged from the Emergency Department (ED). SWIFT includes early education, reassurance, coping strategies, resources and a brief alcohol use intervention in the ED plus follow up telephone counseling, needs assessment and case management referral to necessary services. The intervention targets cognitive, physical, psychiatric and functional outcomes; specifically, post-concussive symptoms, depression, anxiety, posttraumatic stress disorder, alcohol use, community functioning and successful linkage to community resources. It is hypothesized that SWIFT will be acceptable to patients and that participants in the SWIFT group will report superior outcomes on measures of post-concussive symptoms, depression and anxiety, alcohol use and community functioning and will report increased successful linkages to needed resources when compared to the SWIFT-Acute group. The specific aims of the study are: Implement an innovative social work intervention for adults with mTBI (SWIFT). Assess acceptability of SWIFT using qualitative interviews with participants. Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or prevention of post-concussive symptoms, depression, anxiety, posttraumatic stress disorder (PTSD) symptoms, and alcohol use, and on improvement of community functioning and successful linkage to community resources. 80 participants will be randomized to receive SWIFT or SWIFT-Acute. Preliminary intervention effectiveness will be assessed using standard measures of post-concussive symptoms, the primary outcome, depression, anxiety, PTSD, alcohol use, and community functioning. A structured survey will be used to assess linkage to community resources.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SWIFT: Acute Social Work Intervention in the ED and Follow Up
Arm Type
Experimental
Arm Description
Participants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT).
Arm Title
SWIFT-Acute Only: Acute social work intervention in the ED
Arm Type
Active Comparator
Arm Description
acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)
Intervention Type
Behavioral
Intervention Name(s)
SWIFT
Intervention Description
Participants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT).
Intervention Type
Behavioral
Intervention Name(s)
SWIFT-Acute
Intervention Description
acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)
Primary Outcome Measure Information:
Title
Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ)
Time Frame
baseline, 3mo, 6mo
Secondary Outcome Measure Information:
Title
Change in Headache Impact Test (HIT-6)
Time Frame
baseline, 3mo, 6mo
Title
Change in Insomnia Severity Index (ISI)
Time Frame
baseline, 3mo, 6mo
Title
Change in The Post Traumatic Stress Disorder Checklist (PCL-C)
Time Frame
baseline, 3mo, 6mo
Title
Change in Cornell Service Index
Time Frame
baseline, 3mo, 6mo
Title
Change in The Alcohol Use Disorders Identification Test (AUDIT)
Time Frame
baseline, 3mo, 6mo
Title
Change in Community Integration Questionnaire (CIQ)
Time Frame
baseline, 3mo, 6mo
Title
Change in Patient Health Questionnaire (PHQ)-9
Time Frame
baseline, 3mo, 6mo
Title
Change in Generalized Anxiety Disorder (GAD)-7
Time Frame
baseline, 3mo, 6mo
Other Pre-specified Outcome Measures:
Title
Standardized Assessment of Personality: Abbreviated Scale (SAPAS)
Time Frame
baseline
Title
Change in Short Orientation Memory Concentration Test
Time Frame
baseline, 3mo, 6mo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria are based on the World Health Organization definition of mTBI. For inclusion in the study, participants must meet following criteria: At least 18 years of age and English speakers Present to ED with mechanism of trauma to the head, non-penetrating injury, or recent history of trauma to the head Glasgow Coma Scale score of 13-15 after 30 minutes post injury or later upon presentation for healthcare Discharged from the ED in <48 hours from time of admission In addition participants must have one or more of the following symptoms at time of injury: confusion or disorientation loss of consciousness for 30 minutes or less, post-traumatic amnesia for less than 24 hours other transient neurological abnormalities such as focal signs, seizure and intracranial lesion not requiring surgery Exclusion Criteria: the manifestations of mTBI are determined to be caused by penetrating craniocerebral injury patients <18 years of age or non-English speaking patients with intracranial lesion requiring surgery patients admitted to the hospital from ED patients in police custody patients without a telephone contact number
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Moore, MSW, PhD
Email
mm99@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Moore, MSW, PHD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF San Francisco General Hospital and Trauma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Manley, MD, PhD
Email
ManleyG@neurosurg.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Geoffrey Manley, MD, PhD
First Name & Middle Initial & Last Name & Degree
Martha Shumway, PhD

12. IPD Sharing Statement

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SWIFT Study in the ED

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