PTSDTSOS 7 PeerNCT03569878

IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems

A study testing Peer-Integrated Multidisciplinary Collaborative Care and Trauma surgery team notification in people with PTSD and Physical Injury, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: PTSD, Physical Injury
What is being tested?: Peer-Integrated Multidisciplinary Collaborative Care and Trauma surgery team notification
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteUnited States
Study dates: 6 Aug 2018to 12 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington Harborview Level I Trauma Center
Seattle, Washington, 98104

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: PTSD, Physical Injury
Being tested: Peer-Integrated Multidisciplinary Collaborative Care, Trauma surgery team notification
Keywords: PTSD, Physical Injury, Patient Concerns, Emergency Department Utilization
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03569878
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Trauma surgery team notification

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 201812 Jun 2024

First posted26 Jun 2018
Study start6 Aug 2018
Primary completion11 Jul 2023
Study completion12 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03569878
Sponsor's protocol ID: STUDY00005068
Acronym: TSOS 7 Peer
Status last verified: Oct 2024
First submitted: 15 Jun 2018
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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. 2026 Fall;89(3):324-330. doi: 10.1080/00332747.2025.2592725. Epub 2025 Nov 25.
PubMed 41289309
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.
PubMed 41173731
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.
PubMed 39845998
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.
PubMed 32119926

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Effectiveness Trial of an Information Technology Enhanced Peer-Integrated Collaborative Care Intervention for US Trauma Care Systems
ClinicalTrials.gov ID: NCT03569878
Acronym / sponsor ID: TSOS 7 Peer / STUDY00005068
Conditions: PTSD, Physical Injury
Keywords: PTSD, Physical Injury, Patient Concerns, Emergency Department Utilization
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 6 Aug 2018 (actual)
Primary completion: 11 Jul 2023 (actual)
Study completion: 12 Jun 2024 (actual)
First posted: 26 Jun 2018 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Peer-Integrated Multidisciplinary Collaborative Care	Experimental	Behavioral: Peer-Integrated Multidisciplinary Collaborative CareThe 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.
Trauma surgery team notification	Active comparator	Behavioral: Trauma surgery team notificationTrauma surgery team notification of patient emotional distress, with recommendation for mental health inpatient consultation will be the comparator condition.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peer-Integrated Multidisciplinary Collaborative CareCase management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.	Behavioural	Peer-Integrated Multidisciplinary Collaborative Care
Trauma surgery team notificationTrauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition.	Behavioural	Trauma surgery team notification

Primary outcome

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.
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.
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.
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.

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peer-Integrated Multidisciplinary Collaborative Care	225	225
Trauma Surgery Team Notification	225	225

Primary outcome: Number of Patients With 1 or More Emergency Department Visits Per Quarter

Time frame: Baseline injury admission to 12-months post-injury follow-up. Count of participants. Unit: Participants

Measure	Peer-Integrated Multidisciplinary Collaborative Care n = 225	Trauma Surgery Team Notification n = 225
Baseline	225	225
First Quarter	90	79
Second Quarter	52	38
Third Quarter	49	50
Fourth Quarter	47	40

Population analysed: 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.

Primary outcome: Change in Posttraumatic Concern Severity

Time frame: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up. Count of participants. Unit: Participants

Measure	Peer-Integrated Multidisciplinary Collaborative Care n = 225	Trauma Surgery Team Notification n = 225
Baseline	225	225
1 month	152	140
3 month	130	133
6 month	129	97
9 month	101	100
12 month	111	95

Population analysed: 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.

Primary outcome: Change in Posttraumatic Stress Disorder (PTSD) Symptoms

Time frame: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Peer-Integrated Multidisciplinary Collaborative Care n = 225	Trauma Surgery Team Notification n = 225
Baseline	49.3 (11.3)	49.5 (11.4)
1 month	44.0 (15.8)	44.1 (16.4)
3 month	40.2 (15.4)	42.6 (16.4)
6 month	40.2 (16.0)	40.8 (15.8)
9 month	39.9 (15.0)	40.7 (16.8)
12 month	38.6 (15.7)	39.8 (17.1)

Population analysed: 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.

Primary outcome: Change in Functional Status

Time frame: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Peer-Integrated Multidisciplinary Collaborative Care n = 225	Trauma Surgery Team Notification n = 225
Baseline	49.4 (11.1)	50.2 (10.3)
1 month	31.0 (6.8)	30.0 (7.5)
3 month	35.4 (10.2)	33.7 (10.4)
6 month	37.4 (12.1)	36.9 (9.9)
9 month	38.4 (11.3)	37.9 (11.1)
12 month	39.8 (12.3)	39.2 (11.1)

Population analysed: 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.

Adverse events

Time frame: Adverse event data was collected over the course of the year after injury hospitalization.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peer-Integrated Multidisciplinary Collaborative Care	13 of 225 (5.8%)	119 of 225 (52.9%)	6 of 225
Trauma Surgery Team Notification	7 of 225 (3.1%)	117 of 225 (52%)	4 of 225

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41289309Palinkas 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. 2026 Fall;89(3):324-330. doi: 10.1080/00332747.2025.2592725. Epub 2025 Nov 25.
Derived from this study: PubMed 41173731Iles-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.
Derived from this study: PubMed 39845998Zatzick 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.
Derived from this study: PubMed 32119926Scheuer 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With 1 or More Emergency Department Visits Per Quarter (time frame: Baseline injury admission to 12-months post-injury follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03569878, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.