Improving PTSD Management in Primary Care
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 404
- 试验地点
- 7
- 主要终点
- PTSD Symptoms
研究概览
简要总结
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.
详细描述
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:
- 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.
- Assess the success of the PCM intervention implementation and,
- Examine the direct costs of the PCM intervention compared to the TAU control treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Acutely ill and cannot participate in a discussion
- •Does not understand the information
研究组 & 干预措施
Minimally Enhanced Usual Care (MEU)
The MEU condition consists of only the clinician education and patient screening without written feedback.
干预措施: MEU (Other)
PTSD Care Management (PCM)
PCM has six 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.
干预措施: PCM (Other)
结局指标
主要结局
PTSD Symptoms
时间窗: 12 months
same as baseline and 6 months
PTSD Symptoms
时间窗: 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.
PTSD Symptoms
时间窗: 6 months
same as baseline
次要结局
未报告次要终点