NCT00938067

Brief Summary

The purpose of this study is to provide American Indian trauma patients, treated at the Harborview Level 1 urban trauma center, compassionate and culturally sensitive care and to link them to care in their distant tribal communities. The specific aims include 1) interview Native healers to gather information on culture-specific aspects of recovery from traumatic injury and on linking care to tribal communities, 2) conduct a randomized controlled trial to evaluate the implementation and effectiveness of the intervention. The investigators hypothesize that intervention patients will demonstrate greater improvement than controls in post-traumatic stress disorder (PTSD) symptoms, depression, functioning, diagnoses, and fewer new injuries during the 6 months after the index injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

July 9, 2009

Last Update Submit

June 19, 2012

Conditions

Keywords

Injuries, Trauma

Outcome Measures

Primary Outcomes (1)

  • Post Traumatic Stress Disorder Symptoms assessed by a PCL score

    Six months

Secondary Outcomes (1)

  • Depression, Composite International Diagnostic Interview and alcohol abuse/dependence

    Six months

Study Arms (1)

Staying Connected: Care Management

EXPERIMENTAL

The intervention combines case management, psychopharmacological and culturally appropriate and individually tailored trauma support activities with evidence-based treatments.A key feature is the provision of a continuous healing relationship by a care management treatment team.The care manager, informed by the Native healer interviews, will provide a culturally appropriate and ongoing helping relationship to each intervention patient in the weeks and months post-injury and will remain in close contact with the trauma survivor subject for 6 months.Together, the care manager and trauma survivor subject will work on a plan to readjust to daily activities. The care management team will also coordinate psychopharmacological interventions for PTSD and related co-morbidities with primary care and or other community providers.

Behavioral: Staying Connected

Interventions

The overarching goal of the Staying Connected intervention is to establish a compassionate and culturally sensitive treatment trajectory that diminishes posttraumatic suffering by reducing symptomatic distress, improving functional recovery, and reducing the risk of injury recurrence. This trajectory begins with surgical treatment and extends through outpatient care and community rehabilitation. The collaborative care intervention fundamentally restructures the delivery of mental health care within trauma care systems by bringing together providers currently working independently to form an interdisciplinary mental health team. Team members work together and in a liaison capacity with other trauma center providers and community practitioners in order to bridge care across service delivery sectors.

Staying Connected: Care Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Harborview trauma patient 18 years or older
  • self identify as American Indian or Alaska Native
  • speak English

You may not qualify if:

  • non-American Indian or Alaska Native status reported
  • monolingual non-English speaking status
  • age \< 18 years
  • old head, spinal cord or other injuries that prevent participation in the interview
  • any self-inflicted injury, active psychosis, mania, and victims of intimate partner violence who require immediate intervention
  • currently incarcerated patients or a recent history of severe violence which will likely yield criminal charges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesAccidental Injuries

Study Officials

  • Doug Zatzick, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 13, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2011

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations