<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/NCT02239367</url>
  </required_header>
  <id_info>
    <org_study_id>1401014663</org_study_id>
    <secondary_id>P30MH085943</secondary_id>
    <nct_id>NCT02239367</nct_id>
  </id_info>
  <brief_title>Depression Decision Aid: Feasibility Pilot</brief_title>
  <official_title>Electronic Depression Decision Aid for Nurses in Primary Care: Development and Implementation in a Diverse Low-Income Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this proposed pilot study is to test the feasibility and acceptability of a&#xD;
      Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR) and&#xD;
      used by nurses with depressed ambulatory care patients. The Depression Decision Aid protocol&#xD;
      is a streamlined adaptation of an in-person Shared Decision-Making (SDM) intervention, and&#xD;
      its goal is to increase patient involvement in clinically appropriate treatment&#xD;
      decision-making as a way of strengthening treatment engagement and outcomes. The protocol&#xD;
      guides ambulatory care nurses in helping depressed patients (Patient Health Questionnaire-9&#xD;
      [PHQ-9] &gt;10) develop informed treatment preferences through a process of education and values&#xD;
      clarification. We will target patients in the general medical clinic, whether currently&#xD;
      receiving depression treatment or not, because depression is highly prevalent but often&#xD;
      poorly managed in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of this project are to evaluate the acceptability and feasibility of an electronic&#xD;
      Depression Decision Aid protocol with nurses and patients using questionnaire and&#xD;
      administrative data.&#xD;
&#xD;
      One to two nurses will deliver the Decision Aid protocol to 40 low-income patients (aged 21&#xD;
      and over) scoring &gt;10 via routine PHQ-9 screening. Consenting nurses will be assessed&#xD;
      regarding their satisfaction with the protocol following its use with each patient subject.&#xD;
      Nurse fidelity to the protocol will be evaluated via their documentation of protocol use in&#xD;
      the EHR. Consenting patient subjects will be assessed at baseline; week 1 to determine their&#xD;
      decision about depression treatment, satisfaction with the decision-making process; and week&#xD;
      12 to determine treatment initiation or change, treatment adherence, and depressive status.&#xD;
      Medical records will also be examined for documentation of medication prescription and other&#xD;
      depression treatments.&#xD;
&#xD;
      The study will test the following hypothesis concerning the Depression Decision Aid protocol:&#xD;
&#xD;
      1. Feasibility and Acceptability: a) At least 85% of each nurse's intervention sessions will&#xD;
      meet fidelity standards via Electronic Health Record (EHR) data; b) Nurses will report high&#xD;
      levels of satisfaction with the Decision Aid; c) Patients will report high levels of&#xD;
      satisfaction with the decision-making process;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2014</start_date>
  <completion_date type="Actual">April 13, 2015</completion_date>
  <primary_completion_date type="Actual">April 13, 2015</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Use of Depression Decision Aid protocol</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of nurse's intervention sessions based on Electronic Health Record data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the Decision Aid Measure</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Nurse Satisfaction Scale includes a measure of usefulness, clarity, ease of use, and feasibility in terms of timing when using the Decision Aid.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Depression Decision Aid protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention. Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower the elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Depression Decision Aid</intervention_name>
    <description>The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.</description>
    <arm_group_label>Depression Decision Aid protocol</arm_group_label>
    <other_name>Shared Decision Making</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  21 years and older&#xD;
&#xD;
          -  Medical outpatient presenting to the Lincoln Hospital ambulatory care clinic or&#xD;
             geriatric sub-specialty clinic&#xD;
&#xD;
          -  Screen positive for depression (Patient Health Questionnaire-9 score of 10 or greater)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar&#xD;
             disorder&#xD;
&#xD;
          -  High suicide risk&#xD;
&#xD;
          -  Cognitive impairment: Mini Mental Status Exam (MMSE) score less than 24.&#xD;
&#xD;
          -  Acute or severe medical illness (ie. delirium, metastatic cancer, decompensated&#xD;
             cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction&#xD;
             during the three months prior to entry.&#xD;
&#xD;
          -  Inability to speak English or Spanish&#xD;
&#xD;
          -  Aphasia interfering with communication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick J Raue, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lincoln Hospital- the New York City Health and Hospitals Corporation (HHC)</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <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/NCT02239367
org study id: 1401014663
secondary id: P30MH085943
nct id: NCT02239367
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this proposed pilot study is to test the feasibility and acceptability of a
      Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR) and
      used by nurses with depressed ambulatory care patients. The Depression Decision Aid protocol
      is a streamlined adaptation of an in-person Shared Decision-Making (SDM) intervention, and
      its goal is to increase patient involvement in clinically appropriate treatment
      decision-making as a way of strengthening treatment engagement and outcomes. The protocol
      guides ambulatory care nurses in helping depressed patients (Patient Health Questionnaire-9
      [PHQ-9] >10) develop informed treatment preferences through a process of education and values
      clarification. We will target patients in the general medical clinic, whether currently
      receiving depression treatment or not, because depression is highly prevalent but often
      poorly managed in this population.
The aims of this project are to evaluate the acceptability and feasibility of an electronic
      Depression Decision Aid protocol with nurses and patients using questionnaire and
      administrative data.

      One to two nurses will deliver the Decision Aid protocol to 40 low-income patients (aged 21
      and over) scoring >10 via routine PHQ-9 screening. Consenting nurses will be assessed
      regarding their satisfaction with the protocol following its use with each patient subject.
      Nurse fidelity to the protocol will be evaluated via their documentation of protocol use in
      the EHR. Consenting patient subjects will be assessed at baseline; week 1 to determine their
      decision about depression treatment, satisfaction with the decision-making process; and week
      12 to determine treatment initiation or change, treatment adherence, and depressive status.
      Medical records will also be examined for documentation of medication prescription and other
      depression treatments.

      The study will test the following hypothesis concerning the Depression Decision Aid protocol:

      1. Feasibility and Acceptability: a) At least 85% of each nurse's intervention sessions will
      meet fidelity standards via Electronic Health Record (EHR) data; b) Nurses will report high
      levels of satisfaction with the Decision Aid; c) Patients will report high levels of
      satisfaction with the decision-making process;
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Use of Depression Decision Aid protocol
time frame: 12 weeks
description: The number of nurse's intervention sessions based on Electronic Health Record data
measure: Satisfaction with the Decision Aid Measure
time frame: 12 weeks
description: The Nurse Satisfaction Scale includes a measure of usefulness, clarity, ease of use, and feasibility in terms of timing when using the Decision Aid.
arm group label: Depression Decision Aid protocol
arm group type: Experimental
description: The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention. Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower the elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
intervention type: Behavioral
intervention name: Depression Decision Aid
description: The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.
arm group label: Depression Decision Aid protocol
other name: Shared Decision Making
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick J Raue, Ph.D.
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No