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Completed

NCT Number: NCT03569878

IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems

This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.

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Key information

Conditions

PTSD Mental Disorders Physical Injury Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Harborview Level I Trauma Center

Seattle, Washington, 98104, United States

About this study

Collaborative care models are an established standard of care for treating combined mental health and chronic medical conditions in acute and primary care medical settings. However, very few interventions exist for the acute injury population transitioning between settings. While peer interventionist programs have been instituted for care delivery in many conditions, they have not yet been comprehensively integrated into acute post-injury interventions. Literature reviews support the need for comparative effectiveness trials of health care system interventions targeting high need injured patients with multiple complex mental health and medical comorbidities who are at risk for fragmented post-injury health service utilization. This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatient/emergency admission for intentional and/or unintentional injury
  • Score of ≥35 on the PTSD checklist
  • Endorsement of ≥ 1 severe posttraumatic concern

Exclusion criteria

  • Patients who required immediate psychiatric intervention
  • Patients who are not Washington or Oregon State residents
  • Patients who are currently incarcerated
  • Patients not speaking Spanish or English

Treatment and study plan

Peer-Integrated Multidisciplinary Collaborative Care

Behavioral

Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.

Trauma surgery team notification

Behavioral

Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition.

Primary outcomes

  1. Number of Patients With 1 or More Emergency Department Visits Per Quarter

    Time frame: Baseline injury admission to 12-months post-injury follow-up

    Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.

  2. Change in Posttraumatic Concern Severity

    Time frame: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up

    The severity of patient described post-injury concerns as rated by patients on a 1 through 5 scale; 1 being not at all concerning and 5 being extremely concerning. Higher scores are indicative of a worse outcome. The concern outcome can either be represented as a mean severity score or as a percentage of patients with one or more severe concerns.

  3. Change in Posttraumatic Stress Disorder (PTSD) Symptoms

    Time frame: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up

    The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.

  4. Change in Functional Status

    Time frame: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up

    The investigators will use the Medical Outcomes Study Short Form healthy survey (MOS Short Form-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

A Comparative Effectiveness Trial of an Information Technology Enhanced Peer-Integrated Collaborative Care Intervention for US Trauma Care Systems

Acronym: TSOS 7 Peer

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jun 26, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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