跳至主要内容
临床试验/NCT04504149
NCT04504149撤回不适用

Patient Readiness for Improvement Through Motivation, Engagement, and Decision-making for PTSD (CDA 18-186)

VA Office of Research and Development2 个研究点 分布在 1 个国家开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
CollaboRATE

研究概览

简要总结

PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden. Highly effective treatments exist for PTSD, evidence-based psychotherapies, but very few Veterans receive them. Although VA has trained over 8,500 providers in evidence-based psychotherapies for PTSD over the past 10 years, only 6% of the 650,000 VHA patients with PTSD receive an evidence-based psychotherapy. It is critical to connect Veterans with the most effective PTSD treatments and done so in a way that is Veteran-centered. Shared decision making is a patient-centered approach to choosing healthcare treatment options. It has been shown to increase patients' motivation for treatment and ability to stay in treatment long enough to get benefit. It has also been shown to help providers align their practice with evidence-based guidelines. This proposal will refine and pilot test a shared decision making intervention for PTSD to be used in VA primary care clinics, where the vast majority of Veterans with PTSD are treated.

详细描述

Background: Over 1 million Veterans have PTSD and most (80% or more) do not receive first-line treatments, evidence-based psychotherapies, despite significant VA investment to increase access to these treatments. Clinicians often struggle to engage Veterans in evidence-based psychotherapies because they can be emotionally challenging treatments. Engagement could be catalyzed by mental health providers integrated into primary care (i.e., VA's Primary Care-Mental Health Integration, or PC-MHI) to maximize the reach of engagement efforts beyond specialty PTSD settings. Shared decision making, a process by which the patient and provider discuss treatment options, weigh benefits and risks, and select a treatment that meets the patient's needs, addresses known patient and provider barriers to evidence-based psychotherapies, including knowledge, self-efficacy, and trust. However, no study has examined shared decision making for PTSD in primary care. The proposal will address this knowledge gap by developing and refining a shared decision making intervention for PTSD, Patient Readiness for Improvement through Motivation, Engagement, and Decision-making (PRIMED), using input from Veterans with diverse perspectives, PC-MHI providers, and VA operational partners to optimize integration of shared decision making into clinical care. The investigators will collect acceptability and feasibility data to support an application for a future effectiveness-implementation trial.

Significance/Impact: Dr. Chen's proposed research addresses three HSR&D and VA priorities: 1) increase engagement and retention of Veterans in evidence-based PTSD treatments, 2) advance health services research methods, specifically implementation science and user-centered design, which focuses on thorough integration of Veteran and frontline provider input, and 3) support suicide prevention efforts through effective treatment of PTSD, a major risk factor for suicide.

Innovation: The proposed project will promote significant change in current VA clinical practice. PC-MHI providers typically refer out patients with PTSD and defer discussions about treatment options to specialty providers. This proposal will help PC-MHI providers use a formal engagement strategy, shared decision making, to improve patients' knowledge of first-line PTSD treatments and to build motivation for care.

Specific Aims: 1) Refine PRIMED using user-centered design methods and diverse Veterans' perspectives, 2) Beta test PRIMED in one rural and one urban PC-MHI clinic to optimize integration into clinical workflow and achieve satisfactory acceptability and feasibility across a range of settings, 3) Conduct a small, randomized pilot trial (N=40) of PRIMED vs. usual care in two VA PC-MHI clinics to assess the feasibility of study procedures, which will inform a future larger trial.

Methodology: In Aim 1, Dr. Chen will conduct qualitative interviews using user-centered design methods with 25 VA PC-MHI patients with PTSD, oversampling women veterans and racial/ethnic minority veterans, to refine the PRIMED intervention protocol. In Aim 2, Dr. Chen will use rapid, iterative beta-testing with approximately 20 patients to optimize the acceptability and feasibility of delivering PRIMED in the clinical setting and its integration into clinical workflow across varied settings (small rural clinics and large urban clinics). In Aim 3, Dr. Chen will conduct a pilot randomized feasibility trial (N=40) to assess the feasibility of recruiting and randomizing Veterans and measuring treatment engagement and clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult VA patients 18 years who have a documented initial visit to Primary Care-Mental Health Integration for PTSD in the past 90 days at VA Puget Sound

排除标准

  • Cognitive impairment (e.g., moderate or severe history of traumatic brain injury, dementia)
  • Unstable acute psychiatric conditions (e.g., current high-risk for suicide)

结局指标

主要结局

CollaboRATE

时间窗: 2 weeks

CollaboRATE is a a 3-item instrument developed for measuring patient-centeredness within SDM. Good patient acceptability will be defined as minimum ratings of 3 (some effort was made) on a 0 (no effort was made) to 4 (every effort was made) scale for every one of the 3 questionnaire items: 1) How much effort was made to help you understand your health issues?, 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next?

Utilization of evidence-based psychotherapies (EBPs) for PTSD

时间窗: 6 months

The investigators will use chart review methods to identify utilization of EBPs. One method is as a dichotomous (yes/no) measure of initiation.

次要结局

  • PTSD Knowledge Questionnaire(2 weeks)
  • Decisional Conflict Scale(2 weeks)
  • Perceived Stigma and Barriers to Care for Psychological Problems(2 weeks)
  • Generalized Self-Efficacy(2 weeks)
  • Wake Forest Physician Trust Scale(2 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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Shared Decision Making for PTSD in Primary Care | 临床试验