Clinical trial NCT04504149: Shared Decision Making for PTSD in Primary Care
Official title: Patient Readiness for Improvement Through Motivation, Engagement, and Decision-making for PTSD (CDA 18-186)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Keywords: Primary Care
Decision Making, Shared
Stress Disorders, Post-Traumatic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD, hereafter PRIMED, is a primary care-based shared decision making (SDM) intervention that the investigators will develop using UCD methods for VA Primary Care-Mental Health Integration (PC-MHI) clinics to engage Veterans in first-line treatments for PTSD.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Next Steps/Implementation: The research and training activities will prepare the nominee to conduct a multi-site, hybrid type 1 effectiveness-implementation trial to test the effectiveness of PRIMED for increasing receipt of first-line PTSD treatments and to begin to assess implementation barriers and facilitators. Future work to move this research into practice would involve collaborating with operational partners to improve VA SAIL performance measures in mental health, which are weighted to encourage evidence-based psychotherapies.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: CollaboRATE
timeFrame: 2 weeks
measure: Utilization of evidence-based psychotherapies (EBPs) for PTSD
timeFrame: 6 months
measure: Utilization of evidence-based psychotherapies (EBPs) for PTSD
timeFrame: 6 months
measure: Utilization of evidence-based psychotherapies (EBPs) for PTSD
timeFrame: 6 months
Secondary outcomes:
measure: PTSD Knowledge Questionnaire
timeFrame: 2 weeks
measure: Decisional Conflict Scale
timeFrame: 2 weeks
measure: Perceived Stigma and Barriers to Care for Psychological Problems
timeFrame: 2 weeks
measure: Generalized Self-Efficacy
timeFrame: 2 weeks
measure: Wake Forest Physician Trust Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Jessica A. Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: