SWIFT Study in the ED

NCT ID: NCT01893970

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-09-30

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:

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

SWIFT

Intervention Type: BEHAVIORAL

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).

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)

Group Type: ACTIVE_COMPARATOR

SWIFT-Acute

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Megan Moore

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan Moore, MSW, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

UCSF San Francisco General Hospital and Trauma Center

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Megan Moore, MSW, PhD

Role: CONTACT

mm99@uw.edu

Facility Contacts

Geoffrey Manley, MD, PhD

Role: primary

ManleyG@neurosurg.ucsf.edu

Other Identifiers

44360-J

Identifier Type: -

Identifier Source: org_study_id