<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/NCT02986841</url>
  </required_header>
  <id_info>
    <org_study_id>15-01099</org_study_id>
    <nct_id>NCT02986841</nct_id>
  </id_info>
  <brief_title>A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings (&quot;CDE-EHR-PC&quot; Study), Phase 2</brief_title>
  <official_title>A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings (&quot;CDE-EHR-PC&quot; Study), Phase 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements&#xD;
      (CDEs) in primary care settings. The study will be conducted at three adult primary care&#xD;
      clinics, in two large health systems. Each phase will include deliverables essential to move&#xD;
      to the next phase, and an independent Advisory Committee will review progress and make&#xD;
      recommendations at each transition about how best to progress to each subsequent phase. Based&#xD;
      on progress during earlier phases, the Advisory Committee may recommend expansion to&#xD;
      additional clinics or health systems during the second part of Phase 4.&#xD;
&#xD;
      Phase 2 prepares for implementation of the screening and CDS tools as part of routine&#xD;
      clinical practice. A key component of this phase is tailoring the screening and CDS tools&#xD;
      through an iterative process of usability testing and adaptation of their design. In the KTA&#xD;
      framework, this phase corresponds to the 'select, tailor, and implement interventions' step.&#xD;
      Simultaneously, investigators will plan for implementation in one clinic of the MSHS system&#xD;
      by identifying clinical champions, educating clinic leadership and staff, and conducting a&#xD;
      workflow analysis to identify barriers and facilitators of implementation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2016</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Drug Abuse Screening Test (DAST-10)</measure>
    <time_frame>12 Months</time_frame>
    <description>10-item brief screening tool that can be administered by a clinician or self-administered. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes.</description>
  </primary_outcome>
  <enrollment type="Actual">72</enrollment>
  <condition>Substance Abuse</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 50 end-user participants will be enrolled. Approximately 5 to 8 end-user participants&#xD;
        are required for each cycle of usability testing.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking adult individuals aged 18 years or older, and employee at a Wave 1&#xD;
             clinic.&#xD;
&#xD;
          -  Clinical implementation leaders Clinical implementation leaders are practicing PCPs&#xD;
             who provide feedback to the research team and support their colleagues on implementing&#xD;
             screening, using the CDS, and carrying out clinical interventions and referrals to&#xD;
             address unhealthy substance use. One or two primary care providers will be identified&#xD;
             from each clinic site to advise the research team on implementation and to serve as a&#xD;
             resource for their colleagues.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent.&#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>Jennifer McNeely, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York University Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02986841
org study id: 15-01099
nct id: NCT02986841
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements
      (CDEs) in primary care settings. The study will be conducted at three adult primary care
      clinics, in two large health systems. Each phase will include deliverables essential to move
      to the next phase, and an independent Advisory Committee will review progress and make
      recommendations at each transition about how best to progress to each subsequent phase. Based
      on progress during earlier phases, the Advisory Committee may recommend expansion to
      additional clinics or health systems during the second part of Phase 4.

      Phase 2 prepares for implementation of the screening and CDS tools as part of routine
      clinical practice. A key component of this phase is tailoring the screening and CDS tools
      through an iterative process of usability testing and adaptation of their design. In the KTA
      framework, this phase corresponds to the 'select, tailor, and implement interventions' step.
      Simultaneously, investigators will plan for implementation in one clinic of the MSHS system
      by identifying clinical champions, educating clinic leadership and staff, and conducting a
      workflow analysis to identify barriers and facilitators of implementation.
observational model: Ecologic or Community
time perspective: Prospective
measure: Drug Abuse Screening Test (DAST-10)
time frame: 12 Months
description: 10-item brief screening tool that can be administered by a clinician or self-administered. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer McNeely, MD, MS
role: Principal Investigator
affiliation: New York University Medical School
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders