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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer-Integrated Multidisciplinary Collaborative Care | Behavioral | Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Harborview Level I Trauma Center | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41289309 | Derived | 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. | |
| 41173731 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline injury admission to 12-months post-injury follow-up |
|
Adverse event data was collected over the course of the year after injury hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Presentation to emergency department with suicidal ideation or intent | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | Suicidal ideation reported on the Patient Health Questionnaire Nine Item Survey, Item 9 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Zatzick | Department of Psychiatry, University of Washington School of Medicine | 206 744-6701 | dzatzick@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Jul 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Trauma surgery team notification | Behavioral | Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition. |
|
| Derived |
| 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. |
| 39845998 | Derived | 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. |
| 32119926 | Derived | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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. |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-up |
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| 6 |
| 225 |
| 13 |
| 225 |
| 119 |
| 225 |
| EG001 | 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. | 4 | 225 | 7 | 225 | 117 | 225 |
| Death | Injury, poisoning and procedural complications | Non-systematic Assessment |
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