Stress Disorders, Post-Traumatic
Conditions
Keywords
mental health, PTSD, primary care, quality improvement, collaborative care
Brief summary
The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment processes and outcomes in patients seeking primary care from FQHCs and evaluate its effectiveness on improving the processes and outcomes of care for PTSD.
Detailed description
Post-traumatic Stress Disorder (PTSD) is a common problem seen in primary care but the identification and management of PTSD is not routine and would benefit from new approaches. Efforts must overcome patient-, clinician-, and system-level barriers, such as patients' fear of stigma, clinician's time constraints for dealing with psychological issues, gaps in clinician treatment knowledge, and difficulty arranging for referrals to mental health specialists. Unlike mood disorders such as depression, little is known about improving care for PTSD in primary care settings. However, previous experience for treating depression, as well as existing guidelines for addressing PTSD in primary care, provide evidence that effective interventions exist and that multi-faceted interventions are more effective than a single-component approaches. In this project, the RAND Corporation, Clinical Directors Network Inc., Georgetown University Department of Psychiatry, and University of Washington will implement and evaluate a randomized controlled trial (RCT) of a PTSD Care Management (PCM) intervention to detect, treat, and improve PTSD treatment processes and health outcomes in patients seeking primary care from Federally Qualified Health Centers (FQHCs) in Northeastern USA. The three specific aims are to: 1. Evaluate the effectiveness of the PCM intervention compared to a minimally enhanced usual care (MEU) control in reducing PTSD and other mental health symptoms, and improving patients' health-related quality-of-life. 2. Assess the success of the PCM intervention implementation and, 3. Examine the direct costs of the PCM intervention compared to the TAU control treatment. The PCM intervention was developed using principles of Community-Based Participatory Research (CPBR) methods in FQHCs that provide care to the underserved, and is tailored to the settings and populations we will study. This intervention is multi-faceted and includes components and strategies implemented through a Care Manager (CM) to overcome patient-, clinician-, and system-level barriers. There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the FQHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions. The MEU condition will consist of only the clinician education and patient screening without written feedback. Patients will be interviewed during a pre-screening stage to determine PTSD status. A total of 400 of the patients who screen positive will be randomly assigned to the PCM intervention or TAU. Data will be collected from several sources. First, patients will be assessed at baseline, 6 and 12 months via interviews using validated instruments. Second, CMs will compile monthly aggregate data on patient management for patients assigned to the PCM program. Third, FQHC staff will be asked for their feedback about their experiences with implementing the program at the end of the study. The study team will use these data to estimate the direct costs of implementing the PCM program.
Interventions
Care Manager (CM) intervention
The MEU condition consists of only the clinician education and patient screening without written feedback.
Sponsors
Study design
Eligibility
Inclusion criteria
* Has PTSD * Has a scheduled or walk-in appointment with a participating PCC * Speaks English of Spanish * Is between 18 and 65 years old * Expects to receive care in the CHC during the next year
Exclusion criteria
* Acutely ill and cannot participate in a discussion * Does not understand the information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms | 0 months (baseline) | Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PTSD Care Management (PCM) There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
quality improvement: Care Manager (CM) intervention | 184 |
| Treatment-as-Usual (TAU) The TAU condition will consist of only the clinician education and patient screening without written feedback.
Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback. | 171 |
| Total | 355 |
Baseline characteristics
| Characteristic | PTSD Care Management (PCM) | Total | Treatment-as-Usual (TAU) |
|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 12.4 | 42.4 years STANDARD_DEVIATION 12.2 | 42.2 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 95 Participants | 185 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 146 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 95 Participants | 183 Participants | 88 Participants |
| Race (NIH/OMB) Asian | 64 Participants | 124 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 21 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 15 Participants | 10 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 184 participants | 355 participants | 171 participants |
| Sex: Female, Male Female | 150 Participants | 286 Participants | 136 Participants |
| Sex: Female, Male Male | 34 Participants | 69 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 206 | 23 / 198 |
| serious Total, serious adverse events | 0 / 206 | 0 / 198 |
Outcome results
PTSD Symptoms
Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.
Time frame: 0 months (baseline)
Population: all patients who completed the assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTSD Care Management (PCM) | PTSD Symptoms | 71.1 CAPS scores |
| Treatment-as-Usual (TAU) | PTSD Symptoms | 71.0 CAPS scores |
PTSD Symptoms
same as baseline
Time frame: 6 months
Population: Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTSD Care Management (PCM) | PTSD Symptoms | 47.8 CAPS scores |
| Treatment-as-Usual (TAU) | PTSD Symptoms | 49.5 CAPS scores |
PTSD Symptoms
same as baseline and 6 months
Time frame: 12 months
Population: Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTSD Care Management (PCM) | PTSD Symptoms | 46.9 CAPS scores |
| Treatment-as-Usual (TAU) | PTSD Symptoms | 44.2 CAPS scores |