<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/NCT03280225</url>
  </required_header>
  <id_info>
    <org_study_id>SDR 16-195</org_study_id>
    <nct_id>NCT03280225</nct_id>
  </id_info>
  <brief_title>REACH VET Program Evaluation</brief_title>
  <acronym>REACH VET</acronym>
  <official_title>Risk Stratified Enhancements to Clinical Care: Targeting Care for Patients Identified Through Predictive Modeling as Being at High Risk for Suicide, With the Office of Mental Health Operations</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>
      The VA's Office of Mental Health and Suicide Prevention is implementing an new program to&#xD;
      increase suicide prevention outreach for Veterans at highest risk for suicide. Using a&#xD;
      statistical model, REACH VET, short for Recovery Engagement and Coordination for Health -&#xD;
      Veterans Enhanced Treatment, uses information from Veterans' health records to identify those&#xD;
      who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes.&#xD;
      Once a Veteran is identified, his or her VA mental health or primary care provider reaches&#xD;
      out to check on the Veteran's well-being and review their treatment plan to determine if&#xD;
      enhanced care is needed. The goal of the proposed study is to evaluate the implementation of&#xD;
      this program in collaboration with the Partnered Evidence-based Policy Resource Center&#xD;
      (PEPReC). The objectives of this evaluation are to evaluate how well this program is put into&#xD;
      place using a strategy called virtual external facilitation, and to collect data about the&#xD;
      cost of the program and the strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The VA's Office of Mental Health and Suicide Prevention is implementing an innovative new&#xD;
      program to increase suicide prevention outreach and target Veterans at highest risk for&#xD;
      suicide. Using a new predictive model, REACH VET, short for Recovery Engagement and&#xD;
      Coordination for Health - Veterans Enhanced Treatment, analyzes existing data from Veterans'&#xD;
      health records to identify those who are at a statistically elevated risk for suicide,&#xD;
      hospitalization, illness, or other adverse outcomes. Once a Veteran is identified, his or her&#xD;
      VA mental health or primary care provider reaches out to check on the Veteran's well-being&#xD;
      and review their condition(s) and treatment plans to determine if enhanced care is needed.&#xD;
&#xD;
      The goal of the proposed study is to evaluate the implementation of REACH VET in&#xD;
      collaboration with the Partnered Evidence-based Policy Resource Center (PEPReC).&#xD;
&#xD;
      The objectives of this evaluation are to:&#xD;
&#xD;
        1. evaluate the implementation of REACH VET using virtual external facilitation, and&#xD;
&#xD;
        2. collect preliminary data about the cost and cost offsets.&#xD;
&#xD;
      The proposed evaluation will examine the impact of a virtual external facilitation strategy&#xD;
      on the implementation of REACH VET in 28 medical facilities across 7 Veteran Integrated&#xD;
      Service Networks (VISNs) in a stepped wedge design. Primary implementation outcomes include&#xD;
      reach, adoption, and implementation fidelity. Qualitative interviews will be conducted with&#xD;
      implementation facilitators, Suicide Prevention Coordinator(s), clinical leadership, and&#xD;
      providers to identify barriers and facilitators to implementation of REACH VET and the&#xD;
      experience of facilitation. Secondary data will be collected on the cost of the intervention&#xD;
      and the cost of implementation strategy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 13, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reach</measure>
    <time_frame>6 months</time_frame>
    <description>Reach is the proportion of patients identified at each facility who receive the REACH VET intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adoption</measure>
    <time_frame>6 months</time_frame>
    <description>Adoption is the proportion of mental health and primary care providers in each facility that participate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation fidelity</measure>
    <time_frame>6 months</time_frame>
    <description>Implementation fidelity is whether facilities implemented all components of the intervention as directed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of implementation</measure>
    <time_frame>weekly through study completion, an average of 2 years</time_frame>
    <description>Cost of implementation will be estimated by documenting the amount of effort and time needed to offer virtual external facilitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost of intervention</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Cost of the intervention will be estimated by documenting the amount of effort and time needed to implement REACH VET activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organizational Readiness for Change survey</measure>
    <time_frame>1 month</time_frame>
    <description>The Organizational Readiness for Change survey is a quantitative survey that assesses an organization's culture and readiness for change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers, facilitators, experience of facilitation process</measure>
    <time_frame>6 months</time_frame>
    <description>Barriers and facilitators to implementing REACH VET and the experience of the facilitation process will be assessed via qualitative interviews.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Suicide</condition>
  <arm_group>
    <arm_group_label>VISNs requesting implementation support</arm_group_label>
    <description>VA has divided the country into regions of care and these are called Veteran Integrated Service Networks (VISNs). This group consists of VISNs with facilities that need additional implementation support to fully implement REACH VET and that agree to participate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>External facilitation</intervention_name>
    <description>Facilitation is an evidence-based implementation strategy to support sites that have difficulty implementing innovative programs. Facilitation is a multi-faceted &quot;process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship (Powell et al., 2015).&quot; Facilitation has been used nationally across VA to implement a number of different clinical interventions. The current project will examine this minimally intensive version of implementation facilitation, virtual external facilitation.</description>
    <arm_group_label>VISNs requesting implementation support</arm_group_label>
    <other_name>Virtual external facilitation, facilitation, implementation facilitation</other_name>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      No biospecimens will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include facilities receiving virtual external facilitation for&#xD;
        REACH VET and those VA employees at those facilities involved in the implementation or&#xD;
        REACH VET.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  VA employee at a facility receiving virtual external facilitation&#xD;
&#xD;
          -  Involved in REACH VET implementation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a VA employee&#xD;
&#xD;
          -  Not employed at a facility receiving virtual external facilitation&#xD;
&#xD;
          -  Not involved in REACH VET implementation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara J. Landes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <zip>72114-1706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Eastern Colorado Health Care System, Denver, CO</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Reger MA, Luxton DD, Tucker R, Comtois KA, Keen AD, Landes SJ, Matarazzo BB, Thompson C. Implementation Methods for the Caring Contacts Suicide Prevention Intervention. Professional Psychology, Research and Practice. 2017 Oct 1; 48(5):369-377.</citation>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suicide</keyword>
  <keyword>Prevention</keyword>
  <keyword>Implementation</keyword>
  <keyword>Facilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 31, 2021</submitted>
    <returned>September 28, 2021</returned>
    <submitted>January 26, 2022</submitted>
    <returned>March 25, 2022</returned>
    <submitted>May 31, 2022</submitted>
    <returned>March 8, 2023</returned>
    <submitted>May 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03280225
org study id: SDR 16-195
nct id: NCT03280225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The VA's Office of Mental Health and Suicide Prevention is implementing an new program to
      increase suicide prevention outreach for Veterans at highest risk for suicide. Using a
      statistical model, REACH VET, short for Recovery Engagement and Coordination for Health -
      Veterans Enhanced Treatment, uses information from Veterans' health records to identify those
      who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes.
      Once a Veteran is identified, his or her VA mental health or primary care provider reaches
      out to check on the Veteran's well-being and review their treatment plan to determine if
      enhanced care is needed. The goal of the proposed study is to evaluate the implementation of
      this program in collaboration with the Partnered Evidence-based Policy Resource Center
      (PEPReC). The objectives of this evaluation are to evaluate how well this program is put into
      place using a strategy called virtual external facilitation, and to collect data about the
      cost of the program and the strategy.
The VA's Office of Mental Health and Suicide Prevention is implementing an innovative new
      program to increase suicide prevention outreach and target Veterans at highest risk for
      suicide. Using a new predictive model, REACH VET, short for Recovery Engagement and
      Coordination for Health - Veterans Enhanced Treatment, analyzes existing data from Veterans'
      health records to identify those who are at a statistically elevated risk for suicide,
      hospitalization, illness, or other adverse outcomes. Once a Veteran is identified, his or her
      VA mental health or primary care provider reaches out to check on the Veteran's well-being
      and review their condition(s) and treatment plans to determine if enhanced care is needed.

      The goal of the proposed study is to evaluate the implementation of REACH VET in
      collaboration with the Partnered Evidence-based Policy Resource Center (PEPReC).

      The objectives of this evaluation are to:

        1. evaluate the implementation of REACH VET using virtual external facilitation, and

        2. collect preliminary data about the cost and cost offsets.

      The proposed evaluation will examine the impact of a virtual external facilitation strategy
      on the implementation of REACH VET in 28 medical facilities across 7 Veteran Integrated
      Service Networks (VISNs) in a stepped wedge design. Primary implementation outcomes include
      reach, adoption, and implementation fidelity. Qualitative interviews will be conducted with
      implementation facilitators, Suicide Prevention Coordinator(s), clinical leadership, and
      providers to identify barriers and facilitators to implementation of REACH VET and the
      experience of facilitation. Secondary data will be collected on the cost of the intervention
      and the cost of implementation strategy.
observational model: Other
time perspective: Prospective
measure: Reach
time frame: 6 months
description: Reach is the proportion of patients identified at each facility who receive the REACH VET intervention.
measure: Adoption
time frame: 6 months
description: Adoption is the proportion of mental health and primary care providers in each facility that participate.
measure: Implementation fidelity
time frame: 6 months
description: Implementation fidelity is whether facilities implemented all components of the intervention as directed.
measure: Cost of implementation
time frame: weekly through study completion, an average of 2 years
description: Cost of implementation will be estimated by documenting the amount of effort and time needed to offer virtual external facilitation.
measure: Cost of intervention
time frame: up to 6 months
description: Cost of the intervention will be estimated by documenting the amount of effort and time needed to implement REACH VET activities.
measure: Organizational Readiness for Change survey
time frame: 1 month
description: The Organizational Readiness for Change survey is a quantitative survey that assesses an organization's culture and readiness for change.
measure: Barriers, facilitators, experience of facilitation process
time frame: 6 months
description: Barriers and facilitators to implementing REACH VET and the experience of the facilitation process will be assessed via qualitative interviews.
arm group label: VISNs requesting implementation support
description: VA has divided the country into regions of care and these are called Veteran Integrated Service Networks (VISNs). This group consists of VISNs with facilities that need additional implementation support to fully implement REACH VET and that agree to participate.
intervention type: Other
intervention name: External facilitation
description: Facilitation is an evidence-based implementation strategy to support sites that have difficulty implementing innovative programs. Facilitation is a multi-faceted "process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship (Powell et al., 2015)." Facilitation has been used nationally across VA to implement a number of different clinical interventions. The current project will examine this minimally intensive version of implementation facilitation, virtual external facilitation.
arm group label: VISNs requesting implementation support
other name: Virtual external facilitation, facilitation, implementation facilitation
No biospecimens will be collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sara J. Landes, PhD
role: Principal Investigator
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
facility: 
facility: 
country: United States
citation: Reger MA, Luxton DD, Tucker R, Comtois KA, Keen AD, Landes SJ, Matarazzo BB, Thompson C. Implementation Methods for the Caring Contacts Suicide Prevention Intervention. Professional Psychology, Research and Practice. 2017 Oct 1; 48(5):369-377.
responsible party type: Sponsor
mesh term: Suicide
sharing ipd: No
submitted: August 31, 2021
returned: September 28, 2021
submitted: January 26, 2022
returned: March 25, 2022
submitted: May 31, 2022
returned: March 8, 2023
submitted: May 10, 2023