Overview

This trial is active, not recruiting.

Condition stress disorders, post-traumatic
Treatments quality improvement, treatment-as-usual
Phase phase 2
Sponsor RAND
Collaborator Clinical Directors Network
Start date June 2010
End date February 2014
Trial size 500 participants
Trial identifier NCT01401101, 1R01MH082768

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 CHCs and evaluate its effectiveness on improving the processes and outcomes of care for PTSD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
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 practice-based quality improvement
Care Manager (CM) intervention
(Placebo Comparator)
The TAU condition will consist of only the clinician education and patient screening without written feedback.
treatment-as-usual Usual care
The TAU condition will consist of only the clinician education and patient screening without written feedback.

Primary Outcomes

Measure
PTSD symptoms
time frame: 0 months
PTSD symptoms
time frame: 6 months
PTSD symptoms
time frame: 12 months

Secondary Outcomes

Measure
perceived barriers to health care
time frame: 0 months
resilience to stress
time frame: 0 months
use of and satisfaction with health care services
time frame: 0 months
health-related quality of life
time frame: 0 months
perceived barriers to health care
time frame: 6 months
perceived barriers to health care
time frame: 12 months
resilience to stress
time frame: 6 months
resilience to stress
time frame: 12 months
use of and satisfaction with health care services
time frame: 6 months
use of and satisfaction with health care services
time frame: 12 months
health-related quality of life
time frame: 6 months
health-related quality of life
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Improving PTSD Management in Primary Care
Principal investigator Lisa S Meredith, PhD
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 Community Health Centers (CHCs) in Northeastern USA. The three specific aims are to: 1. Evaluate the effectiveness of the PCM intervention compared to a Treatment-as-Usual (TAU) 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 CHCs 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 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. The TAU 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, CHC 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by RAND.