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IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03569878
Acronym
TSOS 7 Peer
Enrollment
450
Registered
2018-06-26
Start date
2018-08-06
Completion date
2024-06-12
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Injury, PTSD

Keywords

PTSD, Physical Injury, Patient Concerns, Emergency Department Utilization

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.

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.

Interventions

BEHAVIORALPeer-Integrated Multidisciplinary Collaborative Care

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

BEHAVIORALTrauma surgery team notification

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

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With 1 or More Emergency Department Visits Per QuarterBaseline injury admission to 12-months post-injury follow-upNumber of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.
Change in Posttraumatic Concern SeverityBaseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-upThe 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.
Change in Posttraumatic Stress Disorder (PTSD) SymptomsBaseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-upThe 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.
Change in Functional StatusBaseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-upThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Peer-Integrated Multidisciplinary Collaborative Care: Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.
225
Trauma Surgery Team Notification
Trauma surgery team notification of patient emotional distress, with recommendation for mental health inpatient consultation will be the comparator condition. Trauma surgery team notification: Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition.
225
Total450

Baseline characteristics

CharacteristicPeer-Integrated Multidisciplinary Collaborative CareTrauma Surgery Team NotificationTotal
Age, Continuous39.3 years
STANDARD_DEVIATION 15.1
38.5 years
STANDARD_DEVIATION 15.5
38.9 years
STANDARD_DEVIATION 15.3
Ethnicity (NIH/OMB)
Hispanic or Latino
56 Participants53 Participants109 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
168 Participants172 Participants340 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
14 Participants6 Participants20 Participants
Race (NIH/OMB)
Asian
5 Participants4 Participants9 Participants
Race (NIH/OMB)
Black or African American
38 Participants32 Participants70 Participants
Race (NIH/OMB)
More than one race
29 Participants26 Participants55 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
5 Participants3 Participants8 Participants
Race (NIH/OMB)
Unknown or Not Reported
22 Participants29 Participants51 Participants
Race (NIH/OMB)
White
112 Participants125 Participants237 Participants
Sex: Female, Male
Female
111 Participants109 Participants220 Participants
Sex: Female, Male
Male
114 Participants116 Participants230 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 2254 / 225
other
Total, other adverse events
119 / 225117 / 225
serious
Total, serious adverse events
13 / 2257 / 225

Outcome results

Primary

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.

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

Population: For the physical functional status outcome, self-report data was collected from individual patients at each time point. Patient self-report interview follow-up completion varied at each time point across the intervention and control conditions. This accounts for samples less than 225 at the 1-, 3-, 6- , 9- and 12-month time points. Mixed-model regression analyses will be incorporated into the data analytic approach.

ArmMeasureGroupValue (MEAN)Dispersion
Peer-Integrated Multidisciplinary Collaborative CareChange in Functional Status6 month37.4 units on a scaleStandard Deviation 12.1
Peer-Integrated Multidisciplinary Collaborative CareChange in Functional StatusBaseline49.4 units on a scaleStandard Deviation 11.1
Peer-Integrated Multidisciplinary Collaborative CareChange in Functional Status9 month38.4 units on a scaleStandard Deviation 11.3
Peer-Integrated Multidisciplinary Collaborative CareChange in Functional Status3 month35.4 units on a scaleStandard Deviation 10.2
Peer-Integrated Multidisciplinary Collaborative CareChange in Functional Status12 month39.8 units on a scaleStandard Deviation 12.3
Peer-Integrated Multidisciplinary Collaborative CareChange in Functional Status1 month31.0 units on a scaleStandard Deviation 6.8
Trauma Surgery Team NotificationChange in Functional Status12 month39.2 units on a scaleStandard Deviation 11.1
Trauma Surgery Team NotificationChange in Functional Status1 month30.0 units on a scaleStandard Deviation 7.5
Trauma Surgery Team NotificationChange in Functional Status3 month33.7 units on a scaleStandard Deviation 10.4
Trauma Surgery Team NotificationChange in Functional Status6 month36.9 units on a scaleStandard Deviation 9.9
Trauma Surgery Team NotificationChange in Functional Status9 month37.9 units on a scaleStandard Deviation 11.1
Trauma Surgery Team NotificationChange in Functional StatusBaseline50.2 units on a scaleStandard Deviation 10.3
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.

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

Population: For the severity of patient described post-injury concerns outcome, self-report data was collected from individual patients at each time point. Patient self-report interview follow-up completion varied at each time point across the intervention and control conditions. This accounts for samples less than 225 at the 1-, 3-, 6- , 9- and 12-month time points. Mixed-model regression analyses will be incorporated into the data analytic approach.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Concern SeverityBaseline225 Participants
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Concern Severity1 month152 Participants
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Concern Severity3 month130 Participants
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Concern Severity6 month129 Participants
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Concern Severity9 month101 Participants
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Concern Severity12 month111 Participants
Trauma Surgery Team NotificationChange in Posttraumatic Concern Severity9 month100 Participants
Trauma Surgery Team NotificationChange in Posttraumatic Concern SeverityBaseline225 Participants
Trauma Surgery Team NotificationChange in Posttraumatic Concern Severity6 month97 Participants
Trauma Surgery Team NotificationChange in Posttraumatic Concern Severity1 month140 Participants
Trauma Surgery Team NotificationChange in Posttraumatic Concern Severity12 month95 Participants
Trauma Surgery Team NotificationChange in Posttraumatic Concern Severity3 month133 Participants
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 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.

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

Population: For the posttraumatic stress symptom outcome, self-report data was collected from individual patients at each time point. Patient self-report interview follow-up completion varied at each time point across the intervention and control conditions. This accounts for samples less than 225 at the 1-, 3-, 6- , 9- and 12-month time points. Mixed-model regression analyses will be incorporated into the data analytic approach.

ArmMeasureGroupValue (MEAN)Dispersion
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Stress Disorder (PTSD) SymptomsBaseline49.3 units on a scaleStandard Deviation 11.3
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Stress Disorder (PTSD) Symptoms1 month44.0 units on a scaleStandard Deviation 15.8
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Stress Disorder (PTSD) Symptoms3 month40.2 units on a scaleStandard Deviation 15.4
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Stress Disorder (PTSD) Symptoms6 month40.2 units on a scaleStandard Deviation 16
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Stress Disorder (PTSD) Symptoms9 month39.9 units on a scaleStandard Deviation 15
Peer-Integrated Multidisciplinary Collaborative CareChange in Posttraumatic Stress Disorder (PTSD) Symptoms12 month38.6 units on a scaleStandard Deviation 15.7
Trauma Surgery Team NotificationChange in Posttraumatic Stress Disorder (PTSD) Symptoms9 month40.7 units on a scaleStandard Deviation 16.8
Trauma Surgery Team NotificationChange in Posttraumatic Stress Disorder (PTSD) SymptomsBaseline49.5 units on a scaleStandard Deviation 11.4
Trauma Surgery Team NotificationChange in Posttraumatic Stress Disorder (PTSD) Symptoms6 month40.8 units on a scaleStandard Deviation 15.8
Trauma Surgery Team NotificationChange in Posttraumatic Stress Disorder (PTSD) Symptoms1 month44.1 units on a scaleStandard Deviation 16.4
Trauma Surgery Team NotificationChange in Posttraumatic Stress Disorder (PTSD) Symptoms12 month39.8 units on a scaleStandard Deviation 17.1
Trauma Surgery Team NotificationChange in Posttraumatic Stress Disorder (PTSD) Symptoms3 month42.6 units on a scaleStandard Deviation 16.4
Primary

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.

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

Population: For the number of emergency department visits outcome, electronic health record data accrued on the entire intent-to-treat sample (N = 450) over the course of the 12-months after injury hospitalization. Mixed-model regression analyses will be incorporated into the data analytic approach.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Peer-Integrated Multidisciplinary Collaborative CareNumber of Patients With 1 or More Emergency Department Visits Per QuarterFourth Quarter47 Participants
Peer-Integrated Multidisciplinary Collaborative CareNumber of Patients With 1 or More Emergency Department Visits Per QuarterBaseline225 Participants
Peer-Integrated Multidisciplinary Collaborative CareNumber of Patients With 1 or More Emergency Department Visits Per QuarterFirst Quarter90 Participants
Peer-Integrated Multidisciplinary Collaborative CareNumber of Patients With 1 or More Emergency Department Visits Per QuarterSecond Quarter52 Participants
Peer-Integrated Multidisciplinary Collaborative CareNumber of Patients With 1 or More Emergency Department Visits Per QuarterThird Quarter49 Participants
Trauma Surgery Team NotificationNumber of Patients With 1 or More Emergency Department Visits Per QuarterThird Quarter50 Participants
Trauma Surgery Team NotificationNumber of Patients With 1 or More Emergency Department Visits Per QuarterSecond Quarter38 Participants
Trauma Surgery Team NotificationNumber of Patients With 1 or More Emergency Department Visits Per QuarterBaseline225 Participants
Trauma Surgery Team NotificationNumber of Patients With 1 or More Emergency Department Visits Per QuarterFourth Quarter40 Participants
Trauma Surgery Team NotificationNumber of Patients With 1 or More Emergency Department Visits Per QuarterFirst Quarter79 Participants

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026