Physical Injury, PTSD
Conditions
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
Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.
Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With 1 or More Emergency Department Visits Per Quarter | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 450 |
Baseline characteristics
| Characteristic | Peer-Integrated Multidisciplinary Collaborative Care | Trauma Surgery Team Notification | Total |
|---|---|---|---|
| Age, Continuous | 39.3 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 Participants | 53 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 172 Participants | 340 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 14 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 32 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 29 Participants | 26 Participants | 55 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 29 Participants | 51 Participants |
| Race (NIH/OMB) White | 112 Participants | 125 Participants | 237 Participants |
| Sex: Female, Male Female | 111 Participants | 109 Participants | 220 Participants |
| Sex: Female, Male Male | 114 Participants | 116 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 225 | 4 / 225 |
| other Total, other adverse events | 119 / 225 | 117 / 225 |
| serious Total, serious adverse events | 13 / 225 | 7 / 225 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Functional Status | 6 month | 37.4 units on a scale | Standard Deviation 12.1 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Functional Status | Baseline | 49.4 units on a scale | Standard Deviation 11.1 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Functional Status | 9 month | 38.4 units on a scale | Standard Deviation 11.3 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Functional Status | 3 month | 35.4 units on a scale | Standard Deviation 10.2 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Functional Status | 12 month | 39.8 units on a scale | Standard Deviation 12.3 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Functional Status | 1 month | 31.0 units on a scale | Standard Deviation 6.8 |
| Trauma Surgery Team Notification | Change in Functional Status | 12 month | 39.2 units on a scale | Standard Deviation 11.1 |
| Trauma Surgery Team Notification | Change in Functional Status | 1 month | 30.0 units on a scale | Standard Deviation 7.5 |
| Trauma Surgery Team Notification | Change in Functional Status | 3 month | 33.7 units on a scale | Standard Deviation 10.4 |
| Trauma Surgery Team Notification | Change in Functional Status | 6 month | 36.9 units on a scale | Standard Deviation 9.9 |
| Trauma Surgery Team Notification | Change in Functional Status | 9 month | 37.9 units on a scale | Standard Deviation 11.1 |
| Trauma Surgery Team Notification | Change in Functional Status | Baseline | 50.2 units on a scale | Standard Deviation 10.3 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Concern Severity | Baseline | 225 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Concern Severity | 1 month | 152 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Concern Severity | 3 month | 130 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Concern Severity | 6 month | 129 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Concern Severity | 9 month | 101 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Concern Severity | 12 month | 111 Participants |
| Trauma Surgery Team Notification | Change in Posttraumatic Concern Severity | 9 month | 100 Participants |
| Trauma Surgery Team Notification | Change in Posttraumatic Concern Severity | Baseline | 225 Participants |
| Trauma Surgery Team Notification | Change in Posttraumatic Concern Severity | 6 month | 97 Participants |
| Trauma Surgery Team Notification | Change in Posttraumatic Concern Severity | 1 month | 140 Participants |
| Trauma Surgery Team Notification | Change in Posttraumatic Concern Severity | 12 month | 95 Participants |
| Trauma Surgery Team Notification | Change in Posttraumatic Concern Severity | 3 month | 133 Participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | Baseline | 49.3 units on a scale | Standard Deviation 11.3 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 1 month | 44.0 units on a scale | Standard Deviation 15.8 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 3 month | 40.2 units on a scale | Standard Deviation 15.4 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 6 month | 40.2 units on a scale | Standard Deviation 16 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 9 month | 39.9 units on a scale | Standard Deviation 15 |
| Peer-Integrated Multidisciplinary Collaborative Care | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 12 month | 38.6 units on a scale | Standard Deviation 15.7 |
| Trauma Surgery Team Notification | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 9 month | 40.7 units on a scale | Standard Deviation 16.8 |
| Trauma Surgery Team Notification | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | Baseline | 49.5 units on a scale | Standard Deviation 11.4 |
| Trauma Surgery Team Notification | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 6 month | 40.8 units on a scale | Standard Deviation 15.8 |
| Trauma Surgery Team Notification | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 1 month | 44.1 units on a scale | Standard Deviation 16.4 |
| Trauma Surgery Team Notification | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 12 month | 39.8 units on a scale | Standard Deviation 17.1 |
| Trauma Surgery Team Notification | Change in Posttraumatic Stress Disorder (PTSD) Symptoms | 3 month | 42.6 units on a scale | Standard Deviation 16.4 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Peer-Integrated Multidisciplinary Collaborative Care | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Fourth Quarter | 47 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Baseline | 225 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Number of Patients With 1 or More Emergency Department Visits Per Quarter | First Quarter | 90 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Second Quarter | 52 Participants |
| Peer-Integrated Multidisciplinary Collaborative Care | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Third Quarter | 49 Participants |
| Trauma Surgery Team Notification | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Third Quarter | 50 Participants |
| Trauma Surgery Team Notification | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Second Quarter | 38 Participants |
| Trauma Surgery Team Notification | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Baseline | 225 Participants |
| Trauma Surgery Team Notification | Number of Patients With 1 or More Emergency Department Visits Per Quarter | Fourth Quarter | 40 Participants |
| Trauma Surgery Team Notification | Number of Patients With 1 or More Emergency Department Visits Per Quarter | First Quarter | 79 Participants |