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

NCT ID: NCT00938067

Last Updated: 2012-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Staying Connected

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Douglas Zatzick

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Doug Zatzick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P60 MD0005-07

Identifier Type: -

Identifier Source: secondary_id

35970-C

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Interrupting Self-Harm Study
NCT03550521 WITHDRAWN NA
Women's Wellbeing Study
NCT07195019 RECRUITING NA
Sharing HaRT in New Expanses
NCT06237439 RECRUITING NA
The Elders' Resilience Curriculum
NCT06045273 COMPLETED NA
2025 Mental Health Education Tool
NCT07227090 ENROLLING_BY_INVITATION NA