<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04504149</url>
  </required_header>
  <id_info>
    <org_study_id>CDX 20-002</org_study_id>
    <nct_id>NCT04504149</nct_id>
  </id_info>
  <brief_title>Shared Decision Making for PTSD in Primary Care</brief_title>
  <acronym>PRIMED-PTSD</acronym>
  <official_title>Patient Readiness for Improvement Through Motivation, Engagement, and Decision-making for PTSD (CDA 18-186)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      PTSD is one of the most common mental health conditions affecting Veterans and is associated&#xD;
      with significant burden. Highly effective treatments exist for PTSD, evidence-based&#xD;
      psychotherapies, but very few Veterans receive them. Although VA has trained over 8,500&#xD;
      providers in evidence-based psychotherapies for PTSD over the past 10 years, only 6% of the&#xD;
      650,000 VHA patients with PTSD receive an evidence-based psychotherapy. It is critical to&#xD;
      connect Veterans with the most effective PTSD treatments and done so in a way that is&#xD;
      Veteran-centered. Shared decision making is a patient-centered approach to choosing&#xD;
      healthcare treatment options. It has been shown to increase patients' motivation for&#xD;
      treatment and ability to stay in treatment long enough to get benefit. It has also been shown&#xD;
      to help providers align their practice with evidence-based guidelines. This proposal will&#xD;
      refine and pilot test a shared decision making intervention for PTSD to be used in VA primary&#xD;
      care clinics, where the vast majority of Veterans with PTSD are treated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Over 1 million Veterans have PTSD and most (80% or more) do not receive&#xD;
      first-line treatments, evidence-based psychotherapies, despite significant VA investment to&#xD;
      increase access to these treatments. Clinicians often struggle to engage Veterans in&#xD;
      evidence-based psychotherapies because they can be emotionally challenging treatments.&#xD;
      Engagement could be catalyzed by mental health providers integrated into primary care (i.e.,&#xD;
      VA's Primary Care-Mental Health Integration, or PC-MHI) to maximize the reach of engagement&#xD;
      efforts beyond specialty PTSD settings. Shared decision making, a process by which the&#xD;
      patient and provider discuss treatment options, weigh benefits and risks, and select a&#xD;
      treatment that meets the patient's needs, addresses known patient and provider barriers to&#xD;
      evidence-based psychotherapies, including knowledge, self-efficacy, and trust. However, no&#xD;
      study has examined shared decision making for PTSD in primary care. The proposal will address&#xD;
      this knowledge gap by developing and refining a shared decision making intervention for PTSD,&#xD;
      Patient Readiness for Improvement through Motivation, Engagement, and Decision-making&#xD;
      (PRIMED), using input from Veterans with diverse perspectives, PC-MHI providers, and VA&#xD;
      operational partners to optimize integration of shared decision making into clinical care.&#xD;
      The investigators will collect acceptability and feasibility data to support an application&#xD;
      for a future effectiveness-implementation trial.&#xD;
&#xD;
      Significance/Impact: Dr. Chen's proposed research addresses three HSR&amp;D and VA priorities: 1)&#xD;
      increase engagement and retention of Veterans in evidence-based PTSD treatments, 2) advance&#xD;
      health services research methods, specifically implementation science and user-centered&#xD;
      design, which focuses on thorough integration of Veteran and frontline provider input, and 3)&#xD;
      support suicide prevention efforts through effective treatment of PTSD, a major risk factor&#xD;
      for suicide.&#xD;
&#xD;
      Innovation: The proposed project will promote significant change in current VA clinical&#xD;
      practice. PC-MHI providers typically refer out patients with PTSD and defer discussions about&#xD;
      treatment options to specialty providers. This proposal will help PC-MHI providers use a&#xD;
      formal engagement strategy, shared decision making, to improve patients' knowledge of&#xD;
      first-line PTSD treatments and to build motivation for care.&#xD;
&#xD;
      Specific Aims: 1) Refine PRIMED using user-centered design methods and diverse Veterans'&#xD;
      perspectives, 2) Beta test PRIMED in one rural and one urban PC-MHI clinic to optimize&#xD;
      integration into clinical workflow and achieve satisfactory acceptability and feasibility&#xD;
      across a range of settings, 3) Conduct a small, randomized pilot trial (N=40) of PRIMED vs.&#xD;
      usual care in two VA PC-MHI clinics to assess the feasibility of study procedures, which will&#xD;
      inform a future larger trial.&#xD;
&#xD;
      Methodology: In Aim 1, Dr. Chen will conduct qualitative interviews using user-centered&#xD;
      design methods with 25 VA PC-MHI patients with PTSD, oversampling women veterans and&#xD;
      racial/ethnic minority veterans, to refine the PRIMED intervention protocol. In Aim 2, Dr.&#xD;
      Chen will use rapid, iterative beta-testing with approximately 20 patients to optimize the&#xD;
      acceptability and feasibility of delivering PRIMED in the clinical setting and its&#xD;
      integration into clinical workflow across varied settings (small rural clinics and large&#xD;
      urban clinics). In Aim 3, Dr. Chen will conduct a pilot randomized feasibility trial (N=40)&#xD;
      to assess the feasibility of recruiting and randomizing Veterans and measuring treatment&#xD;
      engagement and clinical outcomes.&#xD;
&#xD;
      Next Steps/Implementation: The research and training activities will prepare the nominee to&#xD;
      conduct a multi-site, hybrid type 1 effectiveness-implementation trial to test the&#xD;
      effectiveness of PRIMED for increasing receipt of first-line PTSD treatments and to begin to&#xD;
      assess implementation barriers and facilitators. Future work to move this research into&#xD;
      practice would involve collaborating with operational partners to improve VA SAIL performance&#xD;
      measures in mental health, which are weighted to encourage evidence-based psychotherapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Findings from Aims 1 and 2 clarified that any future trial should involve provider- or&#xD;
    clinic-level randomization, not patient-level randomization.&#xD;
  </why_stopped>
  <start_date type="Actual">October 3, 2022</start_date>
  <completion_date type="Actual">November 30, 2022</completion_date>
  <primary_completion_date type="Actual">November 16, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CollaboRATE</measure>
    <time_frame>2 weeks</time_frame>
    <description>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?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Utilization of evidence-based psychotherapies (EBPs) for PTSD</measure>
    <time_frame>6 months</time_frame>
    <description>The investigators will use chart review methods to identify utilization of EBPs. One method is as a dichotomous (yes/no) measure of initiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Utilization of evidence-based psychotherapies (EBPs) for PTSD</measure>
    <time_frame>6 months</time_frame>
    <description>The investigators will measure the number of EBP sessions received in 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Utilization of evidence-based psychotherapies (EBPs) for PTSD</measure>
    <time_frame>6 months</time_frame>
    <description>The investigators will measure time to initiation, defined as days between the initial PC-MHI triage visit and first EBP session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD Knowledge Questionnaire</measure>
    <time_frame>2 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stigma and Barriers to Care for Psychological Problems</measure>
    <time_frame>2 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Self-Efficacy</measure>
    <time_frame>2 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake Forest Physician Trust Scale</measure>
    <time_frame>2 weeks</time_frame>
    <description>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 &quot;Sometimes your doctor cares more about what is convenient for [him or her] than about your medical needs&quot; and &quot;Your doctor is totally honest in telling you about all of the different treatment options available for your condition.&quot; The language will be adapted so that &quot;mental health provider&quot; replaces &quot;doctor&quot; to clearly indicate to patients the relationship of interest.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>PRIMED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shared decision making session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD</intervention_name>
    <description>A primary care-based shared decision making intervention</description>
    <arm_group_label>PRIMED</arm_group_label>
    <other_name>PRIMED</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult VA patients 18 years who have a documented initial visit to Primary Care-Mental&#xD;
             Health Integration for PTSD in the past 90 days at VA Puget Sound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment (e.g., moderate or severe history of traumatic brain injury,&#xD;
             dementia)&#xD;
&#xD;
          -  Unstable acute psychiatric conditions (e.g., current high-risk for suicide)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica A. Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound Health Care System Seattle Division, Seattle, WA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System Seattle Division, Seattle, WA</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary Care</keyword>
  <keyword>Decision Making, Shared</keyword>
  <keyword>Stress Disorders, Post-Traumatic</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04504149
org study id: CDX 20-002
nct id: NCT04504149
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
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
masking: None (Open Label)
measure: CollaboRATE
time frame: 2 weeks
description: 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?
measure: Utilization of evidence-based psychotherapies (EBPs) for PTSD
time frame: 6 months
description: The investigators will use chart review methods to identify utilization of EBPs. One method is as a dichotomous (yes/no) measure of initiation.
measure: Utilization of evidence-based psychotherapies (EBPs) for PTSD
time frame: 6 months
description: The investigators will measure the number of EBP sessions received in 6 months.
measure: Utilization of evidence-based psychotherapies (EBPs) for PTSD
time frame: 6 months
description: The investigators will measure time to initiation, defined as days between the initial PC-MHI triage visit and first EBP session.
measure: PTSD Knowledge Questionnaire
time frame: 2 weeks
description: 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.
measure: Decisional Conflict Scale
time frame: 2 weeks
description: 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.
measure: Perceived Stigma and Barriers to Care for Psychological Problems
time frame: 2 weeks
description: 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.
measure: Generalized Self-Efficacy
time frame: 2 weeks
description: 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.
measure: Wake Forest Physician Trust Scale
time frame: 2 weeks
description: 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.
arm group label: PRIMED
arm group type: Experimental
description: Shared decision making session
arm group label: Usual Care
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD
description: A primary care-based shared decision making intervention
arm group label: PRIMED
other name: PRIMED
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica A. Chen, PhD
role: Principal Investigator
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No