NCT03569878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

4.9 years

First QC Date

June 15, 2018

Results QC Date

July 17, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

PTSDPhysical InjuryPatient ConcernsEmergency Department Utilization

Outcome Measures

Primary Outcomes (4)

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

    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

  • Change in Posttraumatic Concern Severity

    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

    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

    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

Study Arms (2)

Peer-Integrated Multidisciplinary Collaborative Care

EXPERIMENTAL

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

Trauma surgery team notification

ACTIVE COMPARATOR

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

Interventions

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

Peer-Integrated Multidisciplinary Collaborative Care

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

Trauma surgery team notification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Harborview Level I Trauma Center

Seattle, Washington, 98104, United States

Location

Related Publications (4)

  • Palinkas LA, Engstrom A, Knutsen T, Walen ML, Whiteside L, Nehra D, Zatzick D. Implementation of a Face-To-Face Vs Virtual Peer-Integrated Collaborative Care Intervention for Mental Health Treatment of Physical Trauma Survivors: A Qualitative Study of Lessons from the COVID-19 Pandemic. Psychiatry. 2025 Nov 25:1-7. doi: 10.1080/00332747.2025.2592725. Online ahead of print.

  • Iles-Shih M, Kelly G, McManamen M, Buggaveeti AE, Bulger E, Ryan P, Conde C, Huynh M, Ahmad M, Russo J, Wang J, Zatzick D. Can screening and referral for posttraumatic stress improve mental health and substance abuse service delivery at trauma centers? Results from a randomized trial. Injury. 2026 Jan;57(1):112845. doi: 10.1016/j.injury.2025.112845. Epub 2025 Oct 25.

  • Zatzick DF, Bulger EM, Thomas P, Engstrom A, Iles-Shih M, Russo J, Wang J, Shoyer J, Conde C, Abu K, Birk N, Palinkas L, Heagerty P, Whiteside LK, Ryan P, Knutzen T, Maier R. Randomized clinical trial of peer integrated collaborative care intervention after physical injury. Trauma Surg Acute Care Open. 2025 Jan 19;10(1):e001657. doi: 10.1136/tsaco-2024-001657. eCollection 2025.

  • Scheuer H, Engstrom A, Thomas P, Moodliar R, Moloney K, Walen ML, Johnson P, Seo S, Vaziri N, Martinez A, Maier R, Russo J, Sieber S, Anziano P, Anderson K, Bulger E, Whiteside L, Heagerty P, Palinkas L, Zatzick D. A comparative effectiveness trial of an information technology enhanced peer-integrated collaborative care intervention versus enhanced usual care for US trauma care systems: Clinical study protocol. Contemp Clin Trials. 2020 Apr;91:105970. doi: 10.1016/j.cct.2020.105970. Epub 2020 Feb 29.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Douglas Zatzick
Organization
Department of Psychiatry, University of Washington School of Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Psychiatry, Clinical

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

August 6, 2018

Primary Completion

July 11, 2023

Study Completion

June 12, 2024

Last Updated

October 26, 2024

Results First Posted

October 15, 2024

Record last verified: 2024-10

Locations