IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems (TSOS 7 Peer)

October 16, 2024 updated by: Douglas Zatzick, University of Washington

A Comparative Effectiveness Trial of an Information Technology Enhanced Peer-Integrated Collaborative Care Intervention 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Harborview Level I Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer-Integrated Multidisciplinary Collaborative Care
The peer-integrated collaborative care intervention includes front-line trauma center staff (e.g., nursing and masters in social work), joined by injured peer interventionists and supervised by an MD (psychiatrist). The collaborative care team will provide case management, behavioral intervention elements, psychopharmacologic medication recommendations as well as 24/7 cell phone coverage for approximately 6 months post-injury. The intervention will be supported by a novel emergency department health information technology platform.
Behavioral: Peer-Integrated Multidisciplinary Collaborative Care
Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.
Active Comparator: Trauma surgery team notification
Trauma surgery team notification of patient emotional distress, with recommendation for mental health inpatient consultation will be the comparator condition.
Behavioral: Trauma surgery team notification
Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up
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.
Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up
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.
Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up
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.
Baseline injury admission to 12-months post-injury follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Patient-Centered Outcomes Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2018

Primary Completion (Actual)

July 11, 2023

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00005068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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