Trial Outcomes & Findings for IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems (NCT NCT03569878)
NCT ID: NCT03569878
Last Updated: 2024-10-26
Results Overview
Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
Baseline injury admission to 12-months post-injury follow-up
Results posted on
2024-10-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
225
|
|
Overall Study
COMPLETED
|
225
|
225
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems
Baseline characteristics by cohort
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 Participants
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.
|
Trauma Surgery Team Notification
n=225 Participants
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.
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline injury admission to 12-months post-injury follow-upPopulation: 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.
Number of emergency visits will be assessed using the Emergency Department Information Exchange (EDIE). More emergency visits are indicative of a worse outcome.
Outcome measures
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 Participants
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.
|
Trauma Surgery Team Notification
n=225 Participants
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.
|
|---|---|---|
|
Number of Patients With 1 or More Emergency Department Visits Per Quarter
Baseline
|
225 Participants
|
225 Participants
|
|
Number of Patients With 1 or More Emergency Department Visits Per Quarter
First Quarter
|
90 Participants
|
79 Participants
|
|
Number of Patients With 1 or More Emergency Department Visits Per Quarter
Second Quarter
|
52 Participants
|
38 Participants
|
|
Number of Patients With 1 or More Emergency Department Visits Per Quarter
Third Quarter
|
49 Participants
|
50 Participants
|
|
Number of Patients With 1 or More Emergency Department Visits Per Quarter
Fourth Quarter
|
47 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 Participants
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.
|
Trauma Surgery Team Notification
n=225 Participants
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.
|
|---|---|---|
|
Change in Posttraumatic Concern Severity
Baseline
|
225 Participants
|
225 Participants
|
|
Change in Posttraumatic Concern Severity
1 month
|
152 Participants
|
140 Participants
|
|
Change in Posttraumatic Concern Severity
3 month
|
130 Participants
|
133 Participants
|
|
Change in Posttraumatic Concern Severity
6 month
|
129 Participants
|
97 Participants
|
|
Change in Posttraumatic Concern Severity
9 month
|
101 Participants
|
100 Participants
|
|
Change in Posttraumatic Concern Severity
12 month
|
111 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 Participants
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.
|
Trauma Surgery Team Notification
n=225 Participants
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.
|
|---|---|---|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
Baseline
|
49.3 units on a scale
Standard Deviation 11.3
|
49.5 units on a scale
Standard Deviation 11.4
|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
1 month
|
44.0 units on a scale
Standard Deviation 15.8
|
44.1 units on a scale
Standard Deviation 16.4
|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
3 month
|
40.2 units on a scale
Standard Deviation 15.4
|
42.6 units on a scale
Standard Deviation 16.4
|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
6 month
|
40.2 units on a scale
Standard Deviation 16.0
|
40.8 units on a scale
Standard Deviation 15.8
|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
9 month
|
39.9 units on a scale
Standard Deviation 15.0
|
40.7 units on a scale
Standard Deviation 16.8
|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms
12 month
|
38.6 units on a scale
Standard Deviation 15.7
|
39.8 units on a scale
Standard Deviation 17.1
|
PRIMARY outcome
Timeframe: Baseline injury admission and 1-, 3-, 6-, 9- and 12-months post-injury follow-upPopulation: 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.
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.
Outcome measures
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 Participants
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.
|
Trauma Surgery Team Notification
n=225 Participants
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.
|
|---|---|---|
|
Change in Functional Status
9 month
|
38.4 units on a scale
Standard Deviation 11.3
|
37.9 units on a scale
Standard Deviation 11.1
|
|
Change in Functional Status
12 month
|
39.8 units on a scale
Standard Deviation 12.3
|
39.2 units on a scale
Standard Deviation 11.1
|
|
Change in Functional Status
Baseline
|
49.4 units on a scale
Standard Deviation 11.1
|
50.2 units on a scale
Standard Deviation 10.3
|
|
Change in Functional Status
1 month
|
31.0 units on a scale
Standard Deviation 6.8
|
30.0 units on a scale
Standard Deviation 7.5
|
|
Change in Functional Status
3 month
|
35.4 units on a scale
Standard Deviation 10.2
|
33.7 units on a scale
Standard Deviation 10.4
|
|
Change in Functional Status
6 month
|
37.4 units on a scale
Standard Deviation 12.1
|
36.9 units on a scale
Standard Deviation 9.9
|
Adverse Events
Peer-Integrated Multidisciplinary Collaborative Care
Serious events: 13 serious events
Other events: 119 other events
Deaths: 6 deaths
Trauma Surgery Team Notification
Serious events: 7 serious events
Other events: 117 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 participants at risk
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.
|
Trauma Surgery Team Notification
n=225 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Presentation to emergency department with suicidal ideation or intent
|
3.1%
7/225 • Adverse event data was collected over the course of the year after injury hospitalization.
|
1.3%
3/225 • Adverse event data was collected over the course of the year after injury hospitalization.
|
|
Injury, poisoning and procedural complications
Death
|
2.7%
6/225 • Adverse event data was collected over the course of the year after injury hospitalization.
|
1.8%
4/225 • Adverse event data was collected over the course of the year after injury hospitalization.
|
Other adverse events
| Measure |
Peer-Integrated Multidisciplinary Collaborative Care
n=225 participants at risk
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.
|
Trauma Surgery Team Notification
n=225 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
52.9%
119/225 • Adverse event data was collected over the course of the year after injury hospitalization.
|
52.0%
117/225 • Adverse event data was collected over the course of the year after injury hospitalization.
|
Additional Information
Douglas Zatzick
Department of Psychiatry, University of Washington School of Medicine
Phone: 206 744-6701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place