SWIFT Study in the ED

NCT01893970 | Unknown

• 1 other identifier: 44360-J
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ)

  baseline, 3mo, 6mo

Secondary Outcomes (8)

• Change in Headache Impact Test (HIT-6)

  baseline, 3mo, 6mo

• Change in Insomnia Severity Index (ISI)

  baseline, 3mo, 6mo

• Change in The Post Traumatic Stress Disorder Checklist (PCL-C)

  baseline, 3mo, 6mo

• Change in Cornell Service Index

  baseline, 3mo, 6mo

• Change in The Alcohol Use Disorders Identification Test (AUDIT)

  baseline, 3mo, 6mo

Other Outcomes (2)

• Standardized Assessment of Personality: Abbreviated Scale (SAPAS)

  baseline

• Change in Short Orientation Memory Concentration Test

  baseline, 3mo, 6mo

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

SWIFT 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 Social Work Intervention in the ED and Follow Up

SWIFT-Acute BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UCSF San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Megan Moore, MSW, PHD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Moore, MSW, PhD

CONTACT

mm99@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 9, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

US (1)