Staying Connected: Trauma Center to Tribal Community Linkage for Physically Injured American Indian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington
ClinicalTrials.gov Identifier:
NCT00938067
First received: July 9, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Injuries
Behavioral: Staying Connected

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: American Indian and Alaska Native Health Disparities Staying Connected: Trauma Center to Tribal Community Linkage for Physically Injured American Indian Patients

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Post Traumatic Stress Disorder Symptoms assessed by a PCL score [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression, Composite International Diagnostic Interview and alcohol abuse/dependence [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Staying Connected: Care Management
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
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.

Detailed Description:

American Indians are at a greater risk for traumatic life events than the general population and compared to Whites they have a 2.04 (95% CI 1.11, 3.54) fold increased risk of Post Traumatic Stress Disorder (PTSD) symptoms. Among more than 2,900 injured trauma survivors treated at 69 hospitals nationwide, American Indians had the highest risk of all racial/ethnic groups of developing symptoms consistent with a diagnosis of PTSD 12 months after injury. Similarly, among 269 traumatically injured patients hospitalized at 2 level 1 trauma centers in the Western U.S., PTSD and peritraumatic dissociative symptoms were significantly more frequent among American Indians compared to Whites.

Nine percent of 6,000 injured trauma survivors admitted annually to the Harborview Level 1 trauma center are American Indian. Approximately 40 percent of these patients live more than 50 miles from the trauma center, including tribal communities in Eastern Washington and the Olympic Peninsula. Through prior work, researchers have found that care management interventions can reduce PTSD symptoms among diverse injured urban patients. Investigators from the Center of Excellence suggest that American Indian trauma survivors may have unique culture-specific idioms for posttraumatic distress (e.g. "wounded spirit"), and that trauma interventions with indigenous approaches may be productively applied to patients suffering from posttraumatic distress.(5)

In an effort to reduce the risk of PTSD and other general symptoms of trauma among American Indians, we plan to conduct a pilot study to develop and evaluate an American Indian culture specific care management intervention, Staying Connected.

Based on the Trauma Survivors and Support Study (TSOS), the purpose of Staying Connected 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. We hypothesize that intervention patients will demonstrate greater improvement than controls in PTSD symptoms, depression, functioning, diagnoses, and fewer new injuries during the 6 months after the index injury.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Harborview trauma patient 18 years or older
  2. self identify as American Indian or Alaska Native
  3. speak English

Exclusion Criteria:

  1. non-American Indian or Alaska Native status reported
  2. monolingual non-English speaking status
  3. age < 18 years
  4. old head, spinal cord or other injuries that prevent participation in the interview
  5. any self-inflicted injury, active psychosis, mania, and victims of intimate partner violence who require immediate intervention
  6. currently incarcerated patients or a recent history of severe violence which will likely yield criminal charges
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938067

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Doug Zatzick, MD University of Washington
  More Information

No publications provided

Responsible Party: Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00938067     History of Changes
Other Study ID Numbers: 35970-C, P60 MD0005-07
Study First Received: July 9, 2009
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Injuries, Trauma

ClinicalTrials.gov processed this record on September 29, 2014