<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/NCT01697137</url>
  </required_header>
  <id_info>
    <org_study_id>6 R39OT22056-01-01</org_study_id>
    <secondary_id>R39OT22056</secondary_id>
    <nct_id>NCT01697137</nct_id>
  </id_info>
  <brief_title>Patient and Physician Intervention to Increase Organ Donation</brief_title>
  <acronym>DECIDE</acronym>
  <official_title>Patient and Physician Intervention to Increase Organ Donation in Primary Care Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The number of persons on the national solid organ waiting list continues to increase while&#xD;
      the number of donated organs has failed to keep pace. In some portions of northeastern Ohio&#xD;
      the donation rate is as low as 32%. There is a positive association between discussing organ&#xD;
      donation with a primary care physician and signing a donor card. However, such discussions&#xD;
      are rare. The investigators propose a blinded randomized controlled trial to evaluate the&#xD;
      effectiveness of two interventions: 1) showing a donation video to patients in primary care&#xD;
      settings waiting to see their physician and 2) cueing of primary care providers to have&#xD;
      donation discussions with their patients. The study will be conducted throughout Cuyahoga&#xD;
      County in at least 10 ambulatory clinics associated with a single county medical system. Nine&#xD;
      hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that&#xD;
      patients exposed to the interventions will be 1) more likely to consent to donate organs, 2)&#xD;
      more likely to have donation discussions with their primary care providers, and 3) equally&#xD;
      satisfied with the time spent with their doctor compared to patients who are not exposed to&#xD;
      the interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who consent to donate organs</measure>
    <time_frame>1 Day</time_frame>
    <description>Consent either on the electronic donor registry or by completion of a organ donor card.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who reported holding donation discussions with their primary care provider</measure>
    <time_frame>1 Day</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of participants who were satisfied with time spent with their provider on the study date</measure>
    <time_frame>1 Day</time_frame>
    <description>Proportion of participants who were somewhat or very satisfied with the amount of time spent with their provider during the date of the study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">916</enrollment>
  <condition>Tissue and Organ Donation</condition>
  <condition>Communication</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Following enrollment, participants will visit with their primary care provider per usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participant Video and Provider Cueing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will watch a video prior to meeting with their provider. Participants will then cue their providers to discuss organ donation with them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Participant Video and Provider Cueing</intervention_name>
    <description>Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).</description>
    <arm_group_label>Participant Video and Provider Cueing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 2 visits with their primary care provider in the last 3 years&#xD;
&#xD;
          -  Not previously consented to organ donation&#xD;
&#xD;
          -  At least 15.5 years of age&#xD;
&#xD;
          -  Less than 78 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visually impaired&#xD;
&#xD;
          -  Cognitively impaired&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John D Thornton, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The MetroHealth System</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>February 19, 2015</last_update_submitted>
  <last_update_submitted_qc>February 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Daryl Thornton</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01697137
org study id: 6 R39OT22056-01-01
secondary id: R39OT22056
nct id: NCT01697137
lead sponsor: 
has dmc: No
The number of persons on the national solid organ waiting list continues to increase while
      the number of donated organs has failed to keep pace. In some portions of northeastern Ohio
      the donation rate is as low as 32%. There is a positive association between discussing organ
      donation with a primary care physician and signing a donor card. However, such discussions
      are rare. The investigators propose a blinded randomized controlled trial to evaluate the
      effectiveness of two interventions: 1) showing a donation video to patients in primary care
      settings waiting to see their physician and 2) cueing of primary care providers to have
      donation discussions with their patients. The study will be conducted throughout Cuyahoga
      County in at least 10 ambulatory clinics associated with a single county medical system. Nine
      hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that
      patients exposed to the interventions will be 1) more likely to consent to donate organs, 2)
      more likely to have donation discussions with their primary care providers, and 3) equally
      satisfied with the time spent with their doctor compared to patients who are not exposed to
      the interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Proportion of participants who consent to donate organs
time frame: 1 Day
description: Consent either on the electronic donor registry or by completion of a organ donor card.
measure: Proportion of participants who reported holding donation discussions with their primary care provider
time frame: 1 Day
measure: Proportion of participants who were satisfied with time spent with their provider on the study date
time frame: 1 Day
description: Proportion of participants who were somewhat or very satisfied with the amount of time spent with their provider during the date of the study.
arm group label: Usual Care
arm group type: No Intervention
description: Following enrollment, participants will visit with their primary care provider per usual.
arm group label: Participant Video and Provider Cueing
arm group type: Experimental
description: Participants will watch a video prior to meeting with their provider. Participants will then cue their providers to discuss organ donation with them.
intervention type: Behavioral
intervention name: Participant Video and Provider Cueing
description: Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).
arm group label: Participant Video and Provider Cueing
criteria: 
gender: All
minimum age: 15 Years
maximum age: 78 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John D Thornton, MD, MPH
role: Principal Investigator
affiliation: Case Western Reserve University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Daryl Thornton
investigator title: Assistant Professor