IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems

PTSD Clinical Trial

— TSOS 7 Peer  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03569878
• Other study ID #: STUDY00005068
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: May 11, 2024

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: May 11, 2024
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Injury
• PTSD

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington Harborview Level I Trauma Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Emergency Department Utilization	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
Primary	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
Primary	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 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.	Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up
Primary	Change in Functional Status	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.	Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up