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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT03569878
Collaborator
Patient-Centered Outcomes Research Institute (Other)
424
1
2
58.8
7.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer-Integrated Multidisciplinary Collaborative Care
  • Behavioral: Trauma surgery team notification
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparative Effectiveness Trial of an Information Technology Enhanced Peer-Integrated Collaborative Care Intervention for US Trauma Care Systems
Actual Study Start Date :
Aug 6, 2018
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Emergency Department Utilization [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 [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 [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 minumum 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 [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 SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Harborview Level I Trauma Center Seattle Washington United States 98104

Sponsors and Collaborators

  • University of Washington
  • Patient-Centered Outcomes Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Douglas Zatzick, Professor, School of Medicine: Psychiatry, Clinical, University of Washington
ClinicalTrials.gov Identifier:
NCT03569878
Other Study ID Numbers:
  • STUDY00005068
First Posted:
Jun 26, 2018
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Douglas Zatzick, Professor, School of Medicine: Psychiatry, Clinical, University of Washington

Study Results

No Results Posted as of Jan 11, 2022