Trial Outcomes & Findings for Trauma-informed Collaborative Care for Low-income African Americans With PTSD (NCT NCT03591107)
NCT ID: NCT03591107
Last Updated: 2022-12-02
Results Overview
total count of 20 PTSD symptom ratings on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
0 months
Results posted on
2022-12-02
Participant Flow
We completed patient recruitment across 70 days over the course of nine months from October 12, 2018, to July 2, 2019. Patients were approached in the primary care waiting area and if they met inclusion criteria they were asked to complete a brief PTSD symptom checklist, followed by a longer PTSD assessment. If patients met criteria for a provisional diagnosis of PTSD, they were invited to enroll in the study and asked for informed consent (n= 42) adult patients.
Participant milestones
| Measure |
PTSD Care Management (PCM)
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
PTSD Care Management (PCM)
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
Overall Study
Same patient in both arms
|
1
|
1
|
|
Overall Study
Sought care at other clinics
|
0
|
2
|
|
Overall Study
Discharged from clinic
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Trauma-informed Collaborative Care for Low-income African Americans With PTSD
Baseline characteristics by cohort
| Measure |
PTSD Care Management (PCM)
n=19 Participants
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 Participants
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education
< High school
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
High school graduate/GED
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
College degree or graduate
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Marital status
Single
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Marital status
Married or unmarried couple
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital status
Separated/divorced/widowed
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Type of medical insurance
Medicaid
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Type of medical insurance
Medicare
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Type of medical insurance
Employer/private
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of medical insurance
Other (Medicaid and Medicare)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Type of medical insurance
No insurance
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Born in the United States
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Years lived in the United States
|
39.84 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
45.38 Years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
42.75 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Health comorbidity
Depression
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Health comorbidity
Psychoses (
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health comorbidity
Drug use
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health comorbidity
Alcohol use
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Health comorbidity
Heart conditions
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Health comorbidity
Diabetes
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Health comorbidity
Hypertension
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Health comorbidity
Cancer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health comorbidity
Neurological disorders
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 monthstotal count of 20 PTSD symptom ratings on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Outcome measures
| Measure |
PTSD Care Management (PCM)
n=19 Participants
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 Participants
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
PCL-5 Symptom Score
|
73.32 score on a scale
Standard Deviation 13.7
|
72.95 score on a scale
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: 0 monthscount/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)
Outcome measures
| Measure |
PTSD Care Management (PCM)
n=19 Participants
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 Participants
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
Provisional PTSD Diagnosis
|
19 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: approximately 9 monthstotal count of PTSD symptom scores on the 0-4 PTSD Checklist for DSM-5 (PCL-5), range = 0=80, higher scores mean a worse outcome
Outcome measures
| Measure |
PTSD Care Management (PCM)
n=19 Participants
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 Participants
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
PCL-5 Symptom Score
|
37.07 score on a scale
Standard Deviation 17.8
|
47.27 score on a scale
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: approximately 9 monthscount/percent of patients with a provisional diagnosis of PTSD (exceeded a cutoff of 32 and endorsed the required symptoms in each cluster as "Moderately" or higher in frequency following the DSM-5 diagnostic rule)
Outcome measures
| Measure |
PTSD Care Management (PCM)
n=19 Participants
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 Participants
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
Provisional PTSD Diagnosis
|
8 Participants
|
14 Participants
|
Adverse Events
PTSD Care Management (PCM)
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Minimally Enhanced Usual Care (MEU)
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PTSD Care Management (PCM)
n=19 participants at risk
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 participants at risk
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
Psychiatric disorders
Severe or significant emotional or psychological distress
|
15.8%
3/19 • Number of events 3 • 18 months
|
23.8%
5/21 • Number of events 5 • 18 months
|
Other adverse events
| Measure |
PTSD Care Management (PCM)
n=19 participants at risk
In addition to the education and feedback components for both conditions the PCM intervention provides access to a trained Care Manager (CM) who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist.
PTSD Care Management (PCM): Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
|
Minimally Enhanced Usual Care (MEU)
n=21 participants at risk
The MEU condition will consist of only clinician education, patient education (Information Sheet) and feedback about having a probably diagnosis of PTSD to both the clinician and patient.
Minimally Enhanced Usual Care (MEU): Education and feedback alone
|
|---|---|---|
|
Investigations
Release of PII
|
5.3%
1/19 • Number of events 1 • 18 months
|
0.00%
0/21 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place