- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04504149
Shared Decision Making for PTSD in Primary Care (PRIMED-PTSD)
Patient Readiness for Improvement Through Motivation, Engagement, and Decision-making for PTSD (CDA 18-186)
Study Overview
Status
Conditions
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRIMED
Shared decision making session
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A primary care-based shared decision making intervention
Other Names:
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No Intervention: Usual Care
The investigators will characterize usual care using chart review and administrative data to identify medications (prescribed, filled), number of mental health sessions received, types of providers seen, and the content of treatment sessions as captured in chart notes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CollaboRATE
Time Frame: 2 weeks
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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?
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2 weeks
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Utilization of evidence-based psychotherapies (EBPs) for PTSD
Time Frame: 6 months
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The investigators will use chart review methods to identify utilization of EBPs.
One method is as a dichotomous (yes/no) measure of initiation.
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6 months
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Utilization of evidence-based psychotherapies (EBPs) for PTSD
Time Frame: 6 months
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The investigators will measure the number of EBP sessions received in 6 months.
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6 months
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Utilization of evidence-based psychotherapies (EBPs) for PTSD
Time Frame: 6 months
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The investigators will measure time to initiation, defined as days between the initial PC-MHI triage visit and first EBP session.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Knowledge Questionnaire
Time Frame: 2 weeks
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Knowledge about PTSD and its treatment will be assessed with a 43-item true-or-false questionnaire, which was used in a previous RCT of a paper-based PTSD decision aid.
Items will rated as o (incorrect) or 1 (correct), with a total score ranging from 0-43.
Higher scores indicate more accurate knowledge.
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2 weeks
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Decisional Conflict Scale
Time Frame: 2 weeks
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The DCS is a 16-item scale that assesses patient-reported uncertainty around treatment decision-making.
The items also assess the degree to which patients feel informed about risks and benefits, clear about their personal attitudes and values, supported by other(s), and effective in decision making.
The items are rated from 0 (strongly agree) to 4 (strongly disagree), with a range from 0 to 64.
Higher scores indicate better outcomes, i.e., more confidence and feeling more informed.
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2 weeks
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Perceived Stigma and Barriers to Care for Psychological Problems
Time Frame: 2 weeks
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The investigators will use a 10-item version adapted for Veterans to assesses perceived barriers to mental health treatment related to access, stigma, and trust in providers.
Higher scores indicate worse outcomes, i.e., more perceived stigma and barriers to care.
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2 weeks
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Generalized Self-Efficacy
Time Frame: 2 weeks
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A 10-item scale that measures an individual's perceived ability to problem solve, follow through with decisions, and cope effectively with challenges.
Items are rated from 0 (not at all true) to 4 (exactly true) and summed.
Higher scores indicate better outcomes, i.e., greater confidence.
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2 weeks
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Wake Forest Physician Trust Scale
Time Frame: 2 weeks
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A 10-item scale that measures patients' trust in their care providers.
The scale total ranges from 10 to 50.
Higher scores indicate more trust.
Example questions include "Sometimes your doctor cares more about what is convenient for [him or her] than about your medical needs" and "Your doctor is totally honest in telling you about all of the different treatment options available for your condition."
The language will be adapted so that "mental health provider" replaces "doctor" to clearly indicate to patients the relationship of interest.
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2 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Jessica A. Chen, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CDX 20-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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