<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/NCT01671345</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 12-050</org_study_id>
    <nct_id>NCT01671345</nct_id>
  </id_info>
  <brief_title>An Educational Intervention for Type 2 Diabetes Patients</brief_title>
  <acronym>ACTIVet</acronym>
  <official_title>A Randomized Trial of an Educational Intervention in Type 2 Diabetes Patients</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the&#xD;
      prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in&#xD;
      the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a&#xD;
      number of complications including cardiovascular disease, blindness, amputation, and end&#xD;
      stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as&#xD;
      diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care&#xD;
      is related at least in part to effective communication in medical encounters. This project is&#xD;
      designed to test a video intervention to improve patients' communication behaviors. Doctors&#xD;
      will also receive a communication skills training program. The project will assess the impact&#xD;
      of the training programs on communication and outcomes. The study is designed to help make&#xD;
      patient care more patient-centered, which is one of the six aims for improvement in the&#xD;
      Institute Of Medicine report, Crossing the Quality Chasm and is a goal of VA transformation&#xD;
      efforts.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Diabetes is estimated to affect up to 1 in 5 VA patients overall and up to 1 in 4&#xD;
      racial/ethnic minority patients. Patients with low health literacy and minority groups have&#xD;
      more difficulty communicating with physicians, report lower adherence to physicians'&#xD;
      recommendations, and have higher rates of poor diabetes outcomes. Activating patients to use&#xD;
      more effective communication with physicians' can lead to better adherence to treatment and&#xD;
      to better biomedical outcomes. In this project the investigators build upon their prior work&#xD;
      from two Health Services Research &amp; Development (HSRD) funded pilot projects to improve&#xD;
      doctor patient communication in patients with type 2 diabetes mellitus (T2DM). In a&#xD;
      previously funded short-term project, #SHP-08-182, the investigators conducted focus groups&#xD;
      with patients with T2DM to elicit and understand from the patient perspective, barriers to&#xD;
      communicating with their physician. This qualitative work was used in a subsequent pilot&#xD;
      project, #PPO-08-402 to refine and pilot test an educational video to encourage patients to&#xD;
      use active participatory communication in their visits to physicians. This work was&#xD;
      successfully completed and the product is a 10 minute video that in testing was found to be&#xD;
      acceptable to patients and feasible for patients to view immediately preceding their medical&#xD;
      encounter.&#xD;
&#xD;
      Objectives: In this project the investigators propose to test the effectiveness of the video&#xD;
      as an intervention to improved patients' communication. The primary aim is to conduct a&#xD;
      randomized controlled trial of an intervention testing whether the intervention increases&#xD;
      patients' active participatory communication behaviors, patients' post-visit ratings of self&#xD;
      efficacy to communicate, medication adherence, and diabetic control (HgbA1c). There are four&#xD;
      secondary aims which include assessments of the (1) mediators, and (2) moderators of the&#xD;
      relationship of the intervention condition to outcomes, (3) costs of the intervention, and&#xD;
      (4) an evaluation of the feasibility of using the video for pre-visit preparation.&#xD;
&#xD;
      Methods: The investigators will conduct a two group, pre-post, randomized controlled,&#xD;
      single-site trial of the intervention in patients with T2DM. The investigators will recruit&#xD;
      156 patients and their physicians for a pre and post-intervention visit. Physicians will be&#xD;
      trained with the agenda setting module from the Four Habits model. Patients will be&#xD;
      randomized to view a 10 minute intervention or control video prior to their second visit.&#xD;
      Visits will be audio recorded and analyzed for patients' and physicians' communication&#xD;
      behaviors. Self-efficacy to communicate will be collected by self report. Adherence will be&#xD;
      collected by self-report and by medication possession ratio. Diabetic control is collected by&#xD;
      chart review. Analyses will evaluate the relationship of the intervention condition to&#xD;
      outcomes, mediators and moderators of that relationship, and will estimate costs of the&#xD;
      intervention and feasibility of using the video in a busy clinic.&#xD;
&#xD;
      Impacts: VA transformation efforts including interprofessional Patient Aligned Care Teams&#xD;
      (PACT) are focusing attention on patient-centered care. Improved communication is a central&#xD;
      feature of patient centered care. Communication in medical interactions is critical and plays&#xD;
      an important, but often overlooked role in health-care decision making and quality of care.&#xD;
      Patients who have difficulty communicating are less involved in consultations with their&#xD;
      physician, receive less information and support, and are less satisfied with their care. In&#xD;
      turn, these patients may not understand their treatment options, may have less knowledge,&#xD;
      less positive beliefs about treatment and less trust in physician, and may experience poorer&#xD;
      health outcomes. Teaching patients to communicate more effectively is patient-centered&#xD;
      because it inherently supports a patient-driven approach to delivering healthcare. The&#xD;
      investigators' intervention is designed to encourage patients' active communication.&#xD;
      Improving patients' communication is a unique focus that may supplement and add to the VA&#xD;
      efforts in areas such as the Patient Aligned Care Team. In addition, the methodology is not&#xD;
      disease specific and may be a paradigm for improvement in other conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2013</start_date>
  <completion_date type="Actual">January 9, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</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>Patients' Perceived Self-efficacy to Communicate</measure>
    <time_frame>at the baseline ( Visit 1) and post-intervention (Visit 2)</time_frame>
    <description>Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients Active Participatory Communication Behaviors</measure>
    <time_frame>at the baseline ( Visit 1) and post-intervention (Visit 2)</time_frame>
    <description>Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits.&#xD;
Active participatory communication behaviors include four essential elements:&#xD;
telling a medical history;&#xD;
asking questions;&#xD;
being assertive or making requests, and&#xD;
communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>Four weeks post-intervention (i.e. four weeks after Visit 2).</time_frame>
    <description>Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.&#xD;
The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence.&#xD;
The Morisky scale (4-item version) assesses self-reported medication adherence using &quot;yes&quot; or &quot;no&quot; questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.</time_frame>
    <description>Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the intervention will view the intervention video</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomized to control will view an informative video about nutrition and exercise of similar length</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Video</intervention_name>
    <description>A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Speak Up!</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Attention control</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 2 diabetes mellitus&#xD;
&#xD;
          -  Hemoglobin A1c (HgbA1c) greater than or equal to 8&#xD;
&#xD;
          -  Adults, age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lives in skilled nursing facility&#xD;
&#xD;
          -  Dementia (abnormal score on Mini-COG)&#xD;
&#xD;
          -  Terminal medical condition&#xD;
&#xD;
          -  Drug- (e.g., steroid) induced diabetes.&#xD;
&#xD;
          -  Blind or deaf (e.g., unable to view/hear video)&#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>Howard S. Gordon, MD SB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jesse Brown VA Medical Center, Chicago, IL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jesse Brown VA Medical Center, Chicago, IL</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Gordon HS, Street RL. How Physicians, Patients, and Observers Compare on the Use of Qualitative and Quantitative Measures of Physician-Patient Communication. Eval Health Prof. 2016 Dec;39(4):496-511. doi: 10.1177/0163278715625737. Epub 2016 Jan 10.</citation>
    <PMID>26755527</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>June 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>January 10, 2018</results_first_submitted>
  <results_first_submitted_qc>November 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 11, 2019</results_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 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>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible patients (active diagnosis of type 2 diabetes mellitus and a hemoglobin A1c ≥ 7.5) were identified and recruited from the Primary Care clinic and Women's clinics at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago. Recruitment period lasted from 11/27/13 to 11/30/16.</recruitment_details>
      <pre_assignment_details>794 patients were screened; 625 were excluded (not meeting inclusion criteria -188, declined participation/did not respond to invite - 437). 169 patients were enrolled.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Patients randomized to the intervention view the intervention video.&#xD;
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Patients randomized to control view an informative video about diet and nutrition of similar length.&#xD;
Control: Attention control.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>visit with non-participating physician</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Patients randomized to the intervention view the intervention video.&#xD;
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Patients randomized to control view an informative video about diet and nutrition of similar length.&#xD;
Control: Attention control.</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="64"/>
            <count group_id="B2" value="83"/>
            <count group_id="B3" value="147"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="60.19" spread="7.78"/>
                    <measurement group_id="B2" value="59.50" spread="8.21"/>
                    <measurement group_id="B3" value="59.89" spread="7.95"/>
                  </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="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patients' Perceived Self-efficacy to Communicate</title>
        <description>Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.</description>
        <time_frame>at the baseline ( Visit 1) and post-intervention (Visit 2)</time_frame>
        <population>Patients with type 2 diabetes and with HgbA1c more than or equal to 7.5</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients randomized to the intervention view the intervention video.&#xD;
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients randomized to control view an informative video about diet and nutrition of similar length.&#xD;
Control: Attention control</description>
          </group>
        </group_list>
        <measure>
          <title>Patients' Perceived Self-efficacy to Communicate</title>
          <description>Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.</description>
          <population>Patients with type 2 diabetes and with HgbA1c more than or equal to 7.5</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.11" spread="3.24"/>
                    <measurement group_id="O2" value="22.14" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.44" spread="2.40"/>
                    <measurement group_id="O2" value="22.63" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patients Active Participatory Communication Behaviors</title>
        <description>Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits.&#xD;
Active participatory communication behaviors include four essential elements:&#xD;
telling a medical history;&#xD;
asking questions;&#xD;
being assertive or making requests, and&#xD;
communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.</description>
        <time_frame>at the baseline ( Visit 1) and post-intervention (Visit 2)</time_frame>
        <population>Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients randomized to the intervention view the intervention video.&#xD;
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients randomized to control view an informative video about diet and nutrition of similar length.&#xD;
Control: Attention control</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Active Participatory Communication Behaviors</title>
          <description>Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits.&#xD;
Active participatory communication behaviors include four essential elements:&#xD;
telling a medical history;&#xD;
asking questions;&#xD;
being assertive or making requests, and&#xD;
communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.</description>
          <population>Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5</population>
          <units>utterances</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.96" spread="25.89"/>
                    <measurement group_id="O2" value="44.32" spread="29.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.02" spread="30.95"/>
                    <measurement group_id="O2" value="42.92" spread="26.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Adherence</title>
        <description>Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.&#xD;
The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence.&#xD;
The Morisky scale (4-item version) assesses self-reported medication adherence using &quot;yes&quot; or &quot;no&quot; questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.</description>
        <time_frame>Four weeks post-intervention (i.e. four weeks after Visit 2).</time_frame>
        <population>Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal to 7.5</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients randomized to the intervention view the intervention video&#xD;
Intervention Video: A video intervention delivered prior to patients' visit 2 with primary care physician designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients randomized to control view an informative video about diet and nutrition of similar length.&#xD;
Control: Attention control</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence</title>
          <description>Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.&#xD;
The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence.&#xD;
The Morisky scale (4-item version) assesses self-reported medication adherence using &quot;yes&quot; or &quot;no&quot; questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.</description>
          <population>Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal to 7.5</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Measure of Outcome study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.66" spread="14.31"/>
                    <measurement group_id="O2" value="78.78" spread="18.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Morisky scale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.26" spread="1.03"/>
                    <measurement group_id="O2" value="3.23" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin A1c</title>
        <description>Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.</description>
        <time_frame>At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.</time_frame>
        <population>Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Patients randomized to the intervention view the intervention video&#xD;
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Patients randomized to control view an informative video about diet and nutrition of similar length&#xD;
Control: Attention control</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin A1c</title>
          <description>Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.</description>
          <population>Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.07" spread="1.93"/>
                    <measurement group_id="O2" value="9.53" spread="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.07" spread="1.68"/>
                    <measurement group_id="O2" value="9.27" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the baseline (Visit 1) to the follow-up telephone interview that was conducted four weeks post-intervention (i.e. four weeks after Visit 2). As this is a pragmatic study, we could not enforce the same specific time interval on each patient. Time frame varies depending on occurrence of patients' appointments with their physicians in routine clinical practice.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Patients randomized to the intervention view the intervention video.&#xD;
Intervention Video: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Patients randomized to control will view an informative video about diet and nutrition of similar length.&#xD;
Control: Attention control.</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="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </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="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>The analysis of communication outcomes is not yet complete because of delays in coding of transcribed audio-recordings.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Howard S. Gordon, MD</name_or_title>
      <organization>Jesse Brown VA Medical Center</organization>
      <phone>312-569-7331</phone>
      <email>howard.gordon2@va.gov</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/NCT01671345
org study id: IIR 12-050
nct id: NCT01671345
lead sponsor: 
has dmc: No
Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the
      prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in
      the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a
      number of complications including cardiovascular disease, blindness, amputation, and end
      stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as
      diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care
      is related at least in part to effective communication in medical encounters. This project is
      designed to test a video intervention to improve patients' communication behaviors. Doctors
      will also receive a communication skills training program. The project will assess the impact
      of the training programs on communication and outcomes. The study is designed to help make
      patient care more patient-centered, which is one of the six aims for improvement in the
      Institute Of Medicine report, Crossing the Quality Chasm and is a goal of VA transformation
      efforts.
Background: Diabetes is estimated to affect up to 1 in 5 VA patients overall and up to 1 in 4
      racial/ethnic minority patients. Patients with low health literacy and minority groups have
      more difficulty communicating with physicians, report lower adherence to physicians'
      recommendations, and have higher rates of poor diabetes outcomes. Activating patients to use
      more effective communication with physicians' can lead to better adherence to treatment and
      to better biomedical outcomes. In this project the investigators build upon their prior work
      from two Health Services Research & Development (HSRD) funded pilot projects to improve
      doctor patient communication in patients with type 2 diabetes mellitus (T2DM). In a
      previously funded short-term project, #SHP-08-182, the investigators conducted focus groups
      with patients with T2DM to elicit and understand from the patient perspective, barriers to
      communicating with their physician. This qualitative work was used in a subsequent pilot
      project, #PPO-08-402 to refine and pilot test an educational video to encourage patients to
      use active participatory communication in their visits to physicians. This work was
      successfully completed and the product is a 10 minute video that in testing was found to be
      acceptable to patients and feasible for patients to view immediately preceding their medical
      encounter.

      Objectives: In this project the investigators propose to test the effectiveness of the video
      as an intervention to improved patients' communication. The primary aim is to conduct a
      randomized controlled trial of an intervention testing whether the intervention increases
      patients' active participatory communication behaviors, patients' post-visit ratings of self
      efficacy to communicate, medication adherence, and diabetic control (HgbA1c). There are four
      secondary aims which include assessments of the (1) mediators, and (2) moderators of the
      relationship of the intervention condition to outcomes, (3) costs of the intervention, and
      (4) an evaluation of the feasibility of using the video for pre-visit preparation.

      Methods: The investigators will conduct a two group, pre-post, randomized controlled,
      single-site trial of the intervention in patients with T2DM. The investigators will recruit
      156 patients and their physicians for a pre and post-intervention visit. Physicians will be
      trained with the agenda setting module from the Four Habits model. Patients will be
      randomized to view a 10 minute intervention or control video prior to their second visit.
      Visits will be audio recorded and analyzed for patients' and physicians' communication
      behaviors. Self-efficacy to communicate will be collected by self report. Adherence will be
      collected by self-report and by medication possession ratio. Diabetic control is collected by
      chart review. Analyses will evaluate the relationship of the intervention condition to
      outcomes, mediators and moderators of that relationship, and will estimate costs of the
      intervention and feasibility of using the video in a busy clinic.

      Impacts: VA transformation efforts including interprofessional Patient Aligned Care Teams
      (PACT) are focusing attention on patient-centered care. Improved communication is a central
      feature of patient centered care. Communication in medical interactions is critical and plays
      an important, but often overlooked role in health-care decision making and quality of care.
      Patients who have difficulty communicating are less involved in consultations with their
      physician, receive less information and support, and are less satisfied with their care. In
      turn, these patients may not understand their treatment options, may have less knowledge,
      less positive beliefs about treatment and less trust in physician, and may experience poorer
      health outcomes. Teaching patients to communicate more effectively is patient-centered
      because it inherently supports a patient-driven approach to delivering healthcare. The
      investigators' intervention is designed to encourage patients' active communication.
      Improving patients' communication is a unique focus that may supplement and add to the VA
      efforts in areas such as the Patient Aligned Care Team. In addition, the methodology is not
      disease specific and may be a paradigm for improvement in other conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Patients' Perceived Self-efficacy to Communicate
time frame: at the baseline ( Visit 1) and post-intervention (Visit 2)
description: Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.
measure: Patients Active Participatory Communication Behaviors
time frame: at the baseline ( Visit 1) and post-intervention (Visit 2)
description: Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits.
Active participatory communication behaviors include four essential elements:
telling a medical history;
asking questions;
being assertive or making requests, and
communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.
measure: Medication Adherence
time frame: Four weeks post-intervention (i.e. four weeks after Visit 2).
description: Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.
The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence.
The Morisky scale (4-item version) assesses self-reported medication adherence using "yes" or "no" questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.
measure: Hemoglobin A1c
time frame: At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.
description: Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.
arm group label: Intervention
arm group type: Active Comparator
description: Patients randomized to the intervention will view the intervention video
arm group label: Control
arm group type: Placebo Comparator
description: Patients randomized to control will view an informative video about nutrition and exercise of similar length
intervention type: Behavioral
intervention name: Intervention Video
description: A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence
arm group label: Intervention
other name: Speak Up!
intervention type: Behavioral
intervention name: Control
description: Attention control
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Howard S. Gordon, MD SB
role: Principal Investigator
affiliation: Jesse Brown VA Medical Center, Chicago, IL
facility: 
country: United States
citation: Gordon HS, Street RL. How Physicians, Patients, and Observers Compare on the Use of Qualitative and Quantitative Measures of Physician-Patient Communication. Eval Health Prof. 2016 Dec;39(4):496-511. doi: 10.1177/0163278715625737. Epub 2016 Jan 10.
PMID: 26755527
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The analysis of communication outcomes is not yet complete because of delays in coding of transcribed audio-recordings.
point of contact: 