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| ID | Type | Description | Link |
|---|---|---|---|
| IH-1304-6319 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The nation's trauma care system, which includes trauma center hospitals & emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical & mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, & community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns & preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers & policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health & patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury & recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials & standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates & best practice guidelines for post-traumatic stress disorder & alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns & integrates patient concerns & preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients & their caregivers, front-line providers & policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" & "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health & health care?"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | No Intervention | Randomized and will be blindly assessed. | |
| Patient-centered care transition | Experimental | Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Randomized and will be blindly assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care Management | Behavioral | Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | The primary outcome is the endorsement of ≥1 severe posttraumatic concerns. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Change in Depression Symptoms Over the Course of the Six Months After Injury | The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Problems | The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Functional Status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Zatzick, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37747970 | Derived | Prater L, Bulger E, Maier RV, Goldstein E, Thomas P, Russo J, Wang J, Engstrom A, Abu K, Whiteside L, Knutzen T, Iles-Shih M, Heagerty P, Zatzick D. Emergency Department and Inpatient Utilization Reductions and Cost Savings Associated With Trauma Center Mental Health Intervention: Results From a 5-year Longitudinal Randomized Clinical Trial Analysis. Ann Surg. 2024 Jan 1;279(1):17-23. doi: 10.1097/SLA.0000000000006102. Epub 2023 Sep 25. | |
| 33553651 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care - Nurse Notification of Patient Concerns | Randomized, nurse notified of high levels of psychological distress. Will be blindly assessed. |
| FG001 | Patient-centered Care Transition | Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Will be blindly assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care - Nurse Notification of Patient Concerns | Randomized, nurse notified of high levels of psychological distress. Will be blindly assessed. |
| BG001 | Patient-centered Care Transition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | The primary outcome is the endorsement of ≥1 severe posttraumatic concerns. | Posted | Count of Participants | Participants | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
1 year, 6 months
Serious adverse event = Any documented suicide attempt Adverse event = Any PHQ-9, item 9, score >0
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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 | Enhanced Usual Care - Nurse Notification of Patient Concerns | Randomized, nurse notified of high levels of psychological distress. Will be blindly assessed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PHQ-9 Score of >0 | Psychiatric disorders | Systematic Assessment |
Because this was a multifaceted intervention, the investigation did not yield information regarding which components of the treatment were effective in targeting specific outcomes. The intervention extended up until the 6-month injury time point.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Zatzick | University of Washington | 2067446701 | dzatzick@uw.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Patient-centered care transition intervention
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|
The investigators used 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. No other subscales will be used. |
| The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Number of Participants With Suicidal Ideation | The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of > 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Number of Patients Carrying a Weapon | The investigation used a single yes/no item to assess whether the patient was carrying a weapon. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Number of Participants With One or More Emergency Department Visits Over Time | The investigators used population level data on emergency department health service use for the intent-to-treat sample | The investigators assessed emergency department service use over the course of the study. |
| Drug Use Problems | The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used. | The investigators assessed at baseline, 1-, 3-, and 6-month. |
| Derived |
| Whiteside LK, Vrablik MC, Russo J, Bulger EM, Nehra D, Moloney K, Zatzick DF. Leveraging a health information exchange to examine the accuracy of self-report emergency department utilization data among hospitalized injury survivors. Trauma Surg Acute Care Open. 2021 Jan 28;6(1):e000550. doi: 10.1136/tsaco-2020-000550. eCollection 2021. |
| 29533154 | Derived | Zatzick D, Russo J, Thomas P, Darnell D, Teter H, Ingraham L, Whiteside LK, Wang J, Guiney R, Parker L, Sandgren K, Hedrick MK, Van Eaton EG, Jurkovich G. Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial. Psychiatry. 2018 Summer;81(2):141-157. doi: 10.1080/00332747.2017.1354621. Epub 2018 Mar 13. |
Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used. | Posted | Mean | Standard Deviation | units on a scale | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| Primary | Change in Depression Symptoms Over the Course of the Six Months After Injury | The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used. | Posted | Mean | Standard Deviation | units on a scale | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| Secondary | Alcohol Use Problems | The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used. | Posted | Mean | Standard Deviation | units on a scale | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| Secondary | Functional Status | The investigators used 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. No other subscales will be used. | Posted | Mean | Standard Deviation | units on a scale | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| Secondary | Number of Participants With Suicidal Ideation | The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of > 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome. | Posted | Count of Participants | Participants | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| Secondary | Number of Patients Carrying a Weapon | The investigation used a single yes/no item to assess whether the patient was carrying a weapon. | Posted | Count of Participants | Participants | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| Secondary | Number of Participants With One or More Emergency Department Visits Over Time | The investigators used population level data on emergency department health service use for the intent-to-treat sample | Posted | Count of Participants | Participants | The investigators assessed emergency department service use over the course of the study. |
|
|
|
|
| Secondary | Drug Use Problems | The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used. | Posted | Mean | Standard Deviation | units on a scale | The investigators assessed at baseline, 1-, 3-, and 6-month. |
|
|
|
|
| 0 |
| 86 |
| 1 |
| 86 |
| 39 |
| 86 |
| EG001 | Patient-centered Care Transition | Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements. Will be blindly assessed. | 2 | 85 | 2 | 85 | 39 | 85 |
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| D001519 | Behavior |
| 3-month |
|
| 6-month |
|
| 3-month |
|
| 6-month |
|
| 3-month |
|
| 6-month |
|
| 3-month |
|
| 6-month |
|
| 3-month |
|
| 6-month |
|
| 3-month |
|
| 6-month |
|
| 6-9 month |
|
| 9-12 month |
|
| 3-month |
|
| 6-month |
|