Shared Decision Making for PTSD in Primary Care

NCT04504149 | Withdrawn

• 1 other identifier: CDX 20-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

Primary Care; Decision Making, Shared; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (4)

• CollaboRATE

  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?

  2 weeks

• Utilization of evidence-based psychotherapies (EBPs) for PTSD

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

  6 months

• Utilization of evidence-based psychotherapies (EBPs) for PTSD

  The investigators will measure the number of EBP sessions received in 6 months.

  6 months

• Utilization of evidence-based psychotherapies (EBPs) for PTSD

  The investigators will measure time to initiation, defined as days between the initial PC-MHI triage visit and first EBP session.

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

PRIMED

EXPERIMENTAL

Shared decision making session

Behavioral: Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD

Usual Care

NO INTERVENTION

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.

Interventions

Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD BEHAVIORAL

A primary care-based shared decision making intervention

Also known as: PRIMED

PRIMED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jessica A. Chen, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 7, 2020
• Study Start: October 3, 2022
• Primary Completion: November 16, 2022
• Study Completion: November 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)