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SWIFT Study in the ED (SWIFT)

This study is currently recruiting participants.
Verified April 2016 by Megan Moore, University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT01893970
First Posted: July 9, 2013
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Megan Moore, University of Washington
  Purpose

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:

  1. Implement an innovative social work intervention for adults with mTBI (SWIFT).
  2. Assess acceptability of SWIFT using qualitative interviews with participants.
  3. 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.

Condition Intervention
Mild Traumatic Brain Injury Behavioral: SWIFT Behavioral: SWIFT-Acute

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Social Work Intervention for Adults With Mild Traumatic Brain Injury: SWIFT Pilot Study

Resource links provided by NLM:


Further study details as provided by Megan Moore, University of Washington:

Primary Outcome Measures:
  • Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ) [ Time Frame: baseline, 3mo, 6mo ]

Secondary Outcome Measures:
  • Change in Headache Impact Test (HIT-6) [ Time Frame: baseline, 3mo, 6mo ]
  • Change in Insomnia Severity Index (ISI) [ Time Frame: baseline, 3mo, 6mo ]
  • Change in The Post Traumatic Stress Disorder Checklist (PCL-C) [ Time Frame: baseline, 3mo, 6mo ]
  • Change in Cornell Service Index [ Time Frame: baseline, 3mo, 6mo ]
  • Change in The Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: baseline, 3mo, 6mo ]
  • Change in Community Integration Questionnaire (CIQ) [ Time Frame: baseline, 3mo, 6mo ]
  • Change in Patient Health Questionnaire (PHQ)-9 [ Time Frame: baseline, 3mo, 6mo ]
  • Change in Generalized Anxiety Disorder (GAD)-7 [ Time Frame: baseline, 3mo, 6mo ]

Other Outcome Measures:
  • Standardized Assessment of Personality: Abbreviated Scale (SAPAS) [ Time Frame: baseline ]
  • Change in Short Orientation Memory Concentration Test [ Time Frame: baseline, 3mo, 6mo ]

Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SWIFT: Acute Social Work Intervention in the ED and Follow Up
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).
Behavioral: SWIFT
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).
Active Comparator: SWIFT-Acute Only: Acute social work intervention in the ED
acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)
Behavioral: SWIFT-Acute
acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893970


Contacts
Contact: Megan Moore, MSW, PhD mm99@uw.edu

Locations
United States, California
UCSF San Francisco General Hospital and Trauma Center Recruiting
San Francisco, California, United States, 94110
Contact: Geoffrey Manley, MD, PhD       ManleyG@neurosurg.ucsf.edu   
Principal Investigator: Geoffrey Manley, MD, PhD         
Sub-Investigator: Martha Shumway, PhD         
Sponsors and Collaborators
University of Washington
University of California, San Francisco
Investigators
Principal Investigator: Megan Moore, MSW, PHD University of Washington
  More Information

Responsible Party: Megan Moore, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01893970     History of Changes
Other Study ID Numbers: 44360-J
First Submitted: June 28, 2013
First Posted: July 9, 2013
Last Update Posted: April 27, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs