<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/NCT02986958</url>
  </required_header>
  <id_info>
    <org_study_id>R21AG049967</org_study_id>
    <nct_id>NCT02986958</nct_id>
  </id_info>
  <brief_title>Involving Family to Improve Communication in Primary Care</brief_title>
  <acronym>SAMEPage</acronym>
  <official_title>Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins Community Physicians</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates an agenda-setting checklist for patients with cognitive impairment and&#xD;
      their family companions that is completed in the waiting room in advance of a primary care&#xD;
      visit. The study team will conduct a two-group randomized trial to examine feasibility of the&#xD;
      protocol and to compare medical communication (from visit audiotapes) during visits of&#xD;
      patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who&#xD;
      receive usual care (n=50)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study team has established proof of concept for a paper-pencil checklist to be used by&#xD;
      older patients and their companions in the waiting room prior to medical visits. The&#xD;
      checklist is designed to elicit and align patient and companion perspectives regarding&#xD;
      patient health issues to discuss with the doctor, and to stimulate discussion about the&#xD;
      companion's role in the visit. The premise for the checklist is that companions are typically&#xD;
      motivated to support patients during medical visits, but that they often lack knowledge of&#xD;
      the patient's health concerns and preferences for communication assistance.&#xD;
&#xD;
      The study team will conduct a two group pilot randomized trial of up to 100 (50 per group)&#xD;
      patients ages 65+ with cognitive impairment and their unpaid companion to test the effects of&#xD;
      the refined checklist for medical communication. Each patient-companion dyad will be&#xD;
      randomized to the intervention (to receive the checklist) or to a control protocol. The study&#xD;
      will evaluate the feasibility of delivering the study protocol to patients with cognitive&#xD;
      impairment and their companions in primary care, and to generate preliminary evidence&#xD;
      regarding the effect of the checklist on medical communication. For these reasons, the&#xD;
      control group protocol will comprise usual care which is in this case existing clinical&#xD;
      practice. Patients (when feasible), companions, and doctors in both intervention and control&#xD;
      groups will complete in-person post-visit surveys immediately after the visit. Patients (when&#xD;
      feasible) and companions will separately complete follow-up surveys by telephone two weeks&#xD;
      after the doctor visit conducted by a research staff member.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)</measure>
    <time_frame>During enrollment visit, up to 77 minutes</time_frame>
    <description>Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visit Duration</measure>
    <time_frame>During enrollment visit, up to 77 minutes</time_frame>
    <description>Duration of primary care visit in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Verbal Activity</measure>
    <time_frame>During enrollment visit, up to 77 minutes</time_frame>
    <description>Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Companion Verbal Activity</measure>
    <time_frame>During enrollment visit, up to 77 minutes</time_frame>
    <description>Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit</measure>
    <time_frame>During enrollment visit, up to 77 minutes</time_frame>
    <description>The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</measure>
    <time_frame>During Enrollment visit, up to 77 minutes</time_frame>
    <description>The number of patients who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</measure>
    <time_frame>During Enrollment visit, up to 77 minutes</time_frame>
    <description>The number of companions who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</measure>
    <time_frame>During Enrollment visit, up to 77 minutes</time_frame>
    <description>The number of primary care providers who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Checklist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Care as usual with their primary care provider</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-visit patient-family agenda-setting checklist</intervention_name>
    <description>Pre-visit patient-family agenda-setting checklist</description>
    <arm_group_label>Checklist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>routine primary care</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older adults: 65 years or older, established patient of participating primary care&#xD;
             provider, regularly attend medical visits with one or more family member or unpaid&#xD;
             friend &quot;companion(s)&quot;, agree to allow companion to be contacted and participate in the&#xD;
             study, authorize disclosure of Protected Health Information (PHI) in their electronic&#xD;
             health record, able to provide informed consent or have a legally authorized&#xD;
             representative&#xD;
&#xD;
          -  Companion: family member (spouse, adult child, parent, adult sibling) or unpaid friend&#xD;
             who accompanies older adult participant to medical visits.&#xD;
&#xD;
          -  Primary care provider: practicing physician, nurse practitioner or physician assistant&#xD;
             at a participating primary care practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Older adults: younger than 65 years, no evidence of cognitive impairment, do not&#xD;
             attend medical visits with family member or unpaid friend.&#xD;
&#xD;
          -  Companion: paid non-family member who accompanies patient to visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer L Wolff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Community Physicians</name>
      <address>
        <city>Aberdeen</city>
        <state>Maryland</state>
        <zip>21017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Center for Successful Aging</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Community Physicians</name>
      <address>
        <city>Westminster</city>
        <state>Maryland</state>
        <zip>21157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.</citation>
    <PMID>24417565</PMID>
  </reference>
  <reference>
    <citation>Wolff JL, Guan Y, Boyd CM, Vick J, Amjad H, Roth DL, Gitlin LN, Roter DL. Examining the context and helpfulness of family companion contributions to older adults' primary care visits. Patient Educ Couns. 2017 Mar;100(3):487-494. doi: 10.1016/j.pec.2016.10.022. Epub 2016 Oct 25.</citation>
    <PMID>27817986</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>August 8, 2018</results_first_submitted>
  <results_first_submitted_qc>September 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 11, 2018</results_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</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>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02986958/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Checklist</title>
          <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Checklist</title>
          <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="93"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.9" spread="8.0"/>
                    <measurement group_id="B2" value="78.8" spread="7.1"/>
                    <measurement group_id="B3" value="79.9" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Nonwhite race or Hispanic ethnicity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean Mini-Mental State Examination (MMSE)</title>
          <description>The Mini-Mental State Examination (MMSE) is a 30-item questionnaire used to measure cognitive impairment in clinical and research settings. MMSE scores range from 0-30, with higher values indicating less impairment.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.8" spread="7.8"/>
                    <measurement group_id="B2" value="22.5" spread="5.5"/>
                    <measurement group_id="B3" value="21.6" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)</title>
        <description>Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.</description>
        <time_frame>During enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)</title>
          <description>Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.</description>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="0.42"/>
                    <measurement group_id="O2" value="0.68" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).</non_inferiority_desc>
            <p_value>0.046</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visit Duration</title>
        <description>Duration of primary care visit in minutes</description>
        <time_frame>During enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Visit Duration</title>
          <description>Duration of primary care visit in minutes</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" spread="12.5"/>
                    <measurement group_id="O2" value="24.8" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Verbal Activity</title>
        <description>Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.</description>
        <time_frame>During enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Verbal Activity</title>
          <description>Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.</description>
          <units>Proportion of visit statements</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".226" spread="0.14"/>
                    <measurement group_id="O2" value=".271" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Companion Verbal Activity</title>
        <description>Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.</description>
        <time_frame>During enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Companion Verbal Activity</title>
          <description>Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.</description>
          <units>Proportion of visit statements</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".228" spread="0.14"/>
                    <measurement group_id="O2" value=".182" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit</title>
        <description>The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.</description>
        <time_frame>During enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit</title>
          <description>The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</title>
        <description>The number of patients who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
        <time_frame>During Enrollment visit, up to 77 minutes</time_frame>
        <population>The number of patient participants for this patient-reported outcome measure sums to 86 because 7 of the 93 total patient participants were too cognitively impaired to respond to the paper-pencil post-visit survey.</population>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</title>
          <description>The number of patients who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
          <population>The number of patient participants for this patient-reported outcome measure sums to 86 because 7 of the 93 total patient participants were too cognitively impaired to respond to the paper-pencil post-visit survey.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</title>
        <description>The number of companions who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
        <time_frame>During Enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</title>
          <description>The number of companions who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</title>
        <description>The number of primary care providers who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
        <time_frame>During Enrollment visit, up to 77 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Checklist</title>
            <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit</title>
          <description>The number of primary care providers who endorsed &quot;Agree&quot; or &quot;Strongly Agree&quot; to the statement: &quot;Overall, I was satisfied with today's visit.&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Checklist</title>
          <description>One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider&#xD;
Pre-visit patient-family agenda-setting checklist: Pre-visit patient-family agenda-setting checklist</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Care as usual with their primary care provider&#xD;
Usual care: routine primary care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Research Program Manager</name_or_title>
      <organization>Johns Hopkins Bloomberg School of Public Health</organization>
      <phone>410-614-7910</phone>
      <email>dechava1@jhu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02986958
org study id: R21AG049967
nct id: NCT02986958
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study evaluates an agenda-setting checklist for patients with cognitive impairment and
      their family companions that is completed in the waiting room in advance of a primary care
      visit. The study team will conduct a two-group randomized trial to examine feasibility of the
      protocol and to compare medical communication (from visit audiotapes) during visits of
      patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who
      receive usual care (n=50)
The study team has established proof of concept for a paper-pencil checklist to be used by
      older patients and their companions in the waiting room prior to medical visits. The
      checklist is designed to elicit and align patient and companion perspectives regarding
      patient health issues to discuss with the doctor, and to stimulate discussion about the
      companion's role in the visit. The premise for the checklist is that companions are typically
      motivated to support patients during medical visits, but that they often lack knowledge of
      the patient's health concerns and preferences for communication assistance.

      The study team will conduct a two group pilot randomized trial of up to 100 (50 per group)
      patients ages 65+ with cognitive impairment and their unpaid companion to test the effects of
      the refined checklist for medical communication. Each patient-companion dyad will be
      randomized to the intervention (to receive the checklist) or to a control protocol. The study
      will evaluate the feasibility of delivering the study protocol to patients with cognitive
      impairment and their companions in primary care, and to generate preliminary evidence
      regarding the effect of the checklist on medical communication. For these reasons, the
      control group protocol will comprise usual care which is in this case existing clinical
      practice. Patients (when feasible), companions, and doctors in both intervention and control
      groups will complete in-person post-visit surveys immediately after the visit. Patients (when
      feasible) and companions will separately complete follow-up surveys by telephone two weeks
      after the doctor visit conducted by a research staff member.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)
time frame: During enrollment visit, up to 77 minutes
description: Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.
measure: Visit Duration
time frame: During enrollment visit, up to 77 minutes
description: Duration of primary care visit in minutes
measure: Patient Verbal Activity
time frame: During enrollment visit, up to 77 minutes
description: Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.
measure: Companion Verbal Activity
time frame: During enrollment visit, up to 77 minutes
description: Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.
measure: Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit
time frame: During enrollment visit, up to 77 minutes
description: The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.
measure: Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
time frame: During Enrollment visit, up to 77 minutes
description: The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
measure: Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
time frame: During Enrollment visit, up to 77 minutes
description: The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
measure: Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit
time frame: During Enrollment visit, up to 77 minutes
description: The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
arm group label: Checklist
arm group type: Experimental
description: One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider
arm group label: Usual Care
arm group type: Placebo Comparator
description: Care as usual with their primary care provider
intervention type: Other
intervention name: Pre-visit patient-family agenda-setting checklist
description: Pre-visit patient-family agenda-setting checklist
arm group label: Checklist
intervention type: Other
intervention name: Usual care
description: routine primary care
arm group label: Usual Care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer L Wolff, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
facility: 
facility: 
country: United States
citation: Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.
PMID: 24417565
citation: Wolff JL, Guan Y, Boyd CM, Vick J, Amjad H, Roth DL, Gitlin LN, Roter DL. Examining the context and helpfulness of family companion contributions to older adults' primary care visits. Patient Educ Couns. 2017 Mar;100(3):487-494. doi: 10.1016/j.pec.2016.10.022. Epub 2016 Oct 25.
PMID: 27817986
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 