<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/NCT01721200</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0294</org_study_id>
    <secondary_id>12-003011</secondary_id>
    <nct_id>NCT01721200</nct_id>
  </id_info>
  <brief_title>&quot;Learning About Biologics&quot;-Rheumatoid Arthritis</brief_title>
  <official_title>&quot;Learning About Biologics&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geisinger Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized controlled trial designed to examine the efficacy of an&#xD;
      educational decision support tool for patients with rheumatoid arthritis who continue to have&#xD;
      active disease despite use of traditional disease modifying drugs. The study will take place&#xD;
      at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the&#xD;
      treating physician and those providing consent will be randomized to usual care versus use of&#xD;
      the decision support tool.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data suggest that undertreatment of rheumatoid arthritis (RA) patients may be in part due to&#xD;
      inadequate decision support when they face whether or not to start biologic therapy. No&#xD;
      proven way exists to inform or support RA patients who are candidates for biologic therapy.&#xD;
      Communicating information about biologic medication is particularly challenging because of&#xD;
      the sheer number of risks to disclose, the difficulty explaining the risks of extremely rare&#xD;
      adverse events (AEs), and the tendency for people to discount (or underweight) future&#xD;
      benefits.&#xD;
&#xD;
      Dr Liana Fraenkel at Yale University is the Primary Investigator and developer of this&#xD;
      theory-based high quality decision support tool to effectively inform RA patients who are&#xD;
      candidates for biologics. Dr. Eric Newman will be Principal Investigator for the project&#xD;
      which will be conducted at Geisinger Medical Center. All subjects enrolled will complete a&#xD;
      baseline survey and then will be randomized to use of the decision support tool or to usual&#xD;
      care. Those randomized to usual care will be offered the opportunity to access the tool once&#xD;
      enrollment is closed and all follow-up visits have been completed.&#xD;
&#xD;
      Outcomes will be assessed at two and six weeks after the baseline visit by the Geisinger&#xD;
      Telephone Survey and Interviewing Facility. This facility is equipped with 12 computers and&#xD;
      runs two shifts a day. The Survey Unit uses a state-of-the-art Windows based Computer&#xD;
      Assisted Telephone Interview (CATI) system to administer surveys and collect research data.&#xD;
      The group holds 12 interviewer licenses for the CATI system. Trained and experienced&#xD;
      interviewers are available to make the calls from 9 am to 9 pm Monday through Friday and from&#xD;
      10 am to 2 pm on Saturdays.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-physician Communication</measure>
    <time_frame>8 weeks</time_frame>
    <description>Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Biologics</measure>
    <time_frame>8 weeks</time_frame>
    <description>Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To Test Screening and Recruitment Procedures</measure>
    <time_frame>8 weeks</time_frame>
    <description>To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To Test Uptake</measure>
    <time_frame>8 weeks</time_frame>
    <description>To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability to Physicians</measure>
    <time_frame>8 weeks</time_frame>
    <description>Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed:&#xD;
Did the tool make it easier to talk about treatment with your patients?&#xD;
Did the tool increase the amount of time you spent discussing therapy with your patients?&#xD;
Did the tool decrease the amount of time you spent discussing therapy with your patients?&#xD;
Did the tool improve the quality of informed consent for patients initiating biologics?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To Test Adherence to the Intervention</measure>
    <time_frame>8 weeks</time_frame>
    <description>The session management system will record the time spent on each module visited within the tool to assess adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Knowledge</measure>
    <time_frame>8 weeks</time_frame>
    <description>Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Willingness</measure>
    <time_frame>8 weeks</time_frame>
    <description>Willingness: Patients' propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by &quot;Not willing at all&quot; and &quot;Extremely willing&quot; with &quot;Unsure&quot; at the midpoint (65). Higher scores reflect greater willingness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Perceived Knowledge</measure>
    <time_frame>8 weeks</time_frame>
    <description>Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Decision Support Tool</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This study will examine the efficacy of a web-based educational decision support tool.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual Care Group will receive their biologic drug teaching from their rheumatologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Support Tool</intervention_name>
    <description>Educational decision support tool for patients with rheumatoid arthritis</description>
    <arm_group_label>Decision Support Tool</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be at least 18 years of age&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Meet the revised American College of Rheumatology criteria for the diagnosis of RA&#xD;
&#xD;
          -  Have active disease warranting initiation of a new biologic (or small molecule if and&#xD;
             when FDA-approved) therapy as determined by their rheumatologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fail to meet the inclusion criteria&#xD;
&#xD;
          -  Have a current infection&#xD;
&#xD;
          -  Have cancer of any type diagnosed within the past five years (except non-melanoma skin&#xD;
             cancer)&#xD;
&#xD;
          -  Have a history of lymphoma, leukemia, or melanoma&#xD;
&#xD;
          -  Have a chronic inflammatory disease (in addition to rheumatoid arthritis) requiring&#xD;
             treatment with immunosuppressive medications&#xD;
&#xD;
          -  Have chronic liver disease due to hepatitis C or B&#xD;
&#xD;
          -  Are HIV positive&#xD;
&#xD;
          -  Have a positive screening test for tuberculosis (tuberculin skin test or&#xD;
             interferon-gamma release assay) or radiographic lesions suggestive of inactive&#xD;
             tuberculosis and have not completed an adequate course of chemoprophylactic therapy&#xD;
&#xD;
          -  Are hearing or visually impaired&#xD;
&#xD;
          -  Are scheduled for surgery&#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>Liana Fraenkel, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.geisinger.org</url>
    <description>Geisinger Health System</description>
  </link>
  <reference>
    <citation>Fraenkel L, Matzko CK, Webb DE, Oppermann B, Charpentier P, Peters E, Reyna V, Newman ED. Use of Decision Support for Improved Knowledge, Values Clarification, and Informed Choice in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov;67(11):1496-502. doi: 10.1002/acr.22659.</citation>
    <PMID>26195173</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>February 15, 2016</results_first_submitted>
  <results_first_submitted_qc>February 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 19, 2018</results_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>web based interactive learning tool</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were RA patients currently being treated by one of six rheumatologists practicing in the Geisinger Rheumatology Department in Danville, Pennsylvania who were at least 18 years of age, able to speak and read English &amp; had active disease warranting initiation, or change, of a biologic therapy as determined by their treating rheumatologist.</recruitment_details>
      <pre_assignment_details>Subjects excluded if hearing or visually impaired; scheduled for surgery;current infection; cancer past five years (except non-melanoma),lymphoma, leukemia,melanoma;chronic inflammatory disease (+ RA) immunosuppressive RX; chronic liver disease, hepatitis C or B;HIV +; TB+x-ray lesions of inactive TB &amp; no chemoprophylactic therapy..</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Decision Support Tool</title>
          <description>This study will examine the efficacy of a web-based educational decision support tool.&#xD;
Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual Care Group will receive their biologic drug teaching from their rheumatologist.&#xD;
Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine 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="62"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 2 Week Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </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="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>152 subjects approached. out of this number 125 patients agreed to participate and were randomized.&#xD;
125 subjects completed baseline survey. 63 were randomized to control group and 62 to intervention. 61 completed two week follow-up survey in control group and 60 in intervention group.&#xD;
58 completed 8 week survey and 59 in intervention group.</population>
      <group_list>
        <group group_id="B1">
          <title>Decision Support Tool</title>
          <description>This study will examine the efficacy of a web-based educational decision support tool.&#xD;
Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual Care Group will receive their biologic drug teaching from their rheumatologist.&#xD;
Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine 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="62"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="125"/>
          </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="62"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_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="54.3" spread="13.3"/>
                    <measurement group_id="B2" value="56.2" spread="11.4"/>
                    <measurement group_id="B3" value="55.3" spread="12.4"/>
                  </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="41"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one of the above races</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks</title>
        <description>We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Randomized to view the decision support tool.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual Care</description>
          </group>
        </group_list>
        <measure>
          <title>The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks</title>
          <description>We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.</description>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-physician Communication</title>
        <description>Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>1 Intervention</title>
          </group>
          <group group_id="O2">
            <title>Control</title>
          </group>
        </group_list>
        <measure>
          <title>Patient-physician Communication</title>
          <description>Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.</description>
          <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="59"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8" spread="12.2"/>
                    <measurement group_id="O2" value="35.6" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Biologics</title>
        <description>Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>1 Intervention</title>
          </group>
          <group group_id="O2">
            <title>Control</title>
          </group>
        </group_list>
        <measure>
          <title>Use of Biologics</title>
          <description>Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.</description>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Test Screening and Recruitment Procedures</title>
        <description>To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.</description>
        <time_frame>8 weeks</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Randomized to view the decision support tool.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual Care</description>
          </group>
        </group_list>
        <measure>
          <title>To Test Screening and Recruitment Procedures</title>
          <description>To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Test Uptake</title>
        <description>To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.</description>
        <time_frame>8 weeks</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Randomized to view the decision support tool.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual Care</description>
          </group>
        </group_list>
        <measure>
          <title>To Test Uptake</title>
          <description>To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability to Physicians</title>
        <description>Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed:&#xD;
Did the tool make it easier to talk about treatment with your patients?&#xD;
Did the tool increase the amount of time you spent discussing therapy with your patients?&#xD;
Did the tool decrease the amount of time you spent discussing therapy with your patients?&#xD;
Did the tool improve the quality of informed consent for patients initiating biologics?</description>
        <time_frame>8 weeks</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
          </group>
        </group_list>
        <measure>
          <title>Acceptability to Physicians</title>
          <description>Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed:&#xD;
Did the tool make it easier to talk about treatment with your patients?&#xD;
Did the tool increase the amount of time you spent discussing therapy with your patients?&#xD;
Did the tool decrease the amount of time you spent discussing therapy with your patients?&#xD;
Did the tool improve the quality of informed consent for patients initiating biologics?</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Test Adherence to the Intervention</title>
        <description>The session management system will record the time spent on each module visited within the tool to assess adherence.</description>
        <time_frame>8 weeks</time_frame>
        <population>These data were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care Group will receive their biologic drug teaching from their rheumatologist.&#xD;
Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.</description>
          </group>
          <group group_id="O2">
            <title>Decision Support Tool</title>
            <description>This study will examine the efficacy of a web-based educational decision support tool.&#xD;
Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis</description>
          </group>
        </group_list>
        <measure>
          <title>To Test Adherence to the Intervention</title>
          <description>The session management system will record the time spent on each module visited within the tool to assess adherence.</description>
          <population>These data were not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Knowledge</title>
        <description>Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>1 Intervention</title>
          </group>
          <group group_id="O2">
            <title>Control</title>
          </group>
        </group_list>
        <measure>
          <title>Changes in Knowledge</title>
          <description>Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="-1" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="-2" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Willingness</title>
        <description>Willingness: Patients' propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by &quot;Not willing at all&quot; and &quot;Extremely willing&quot; with &quot;Unsure&quot; at the midpoint (65). Higher scores reflect greater willingness.</description>
        <time_frame>8 weeks</time_frame>
        <population>Follow-up data not collected because of ceiling effect.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Randomized to view the decision support tool.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual Care</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Willingness</title>
          <description>Willingness: Patients' propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by &quot;Not willing at all&quot; and &quot;Extremely willing&quot; with &quot;Unsure&quot; at the midpoint (65). Higher scores reflect greater willingness.</description>
          <population>Follow-up data not collected because of ceiling effect.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Perceived Knowledge</title>
        <description>Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
          </group>
          <group group_id="O2">
            <title>Control</title>
          </group>
        </group_list>
        <measure>
          <title>Changes in Perceived Knowledge</title>
          <description>Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.7" lower_limit="-33" upper_limit="0"/>
                    <measurement group_id="O2" value="-8.3" lower_limit="-25" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Usual Care Group will receive their biologic drug teaching from their rheumatologist.&#xD;
Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.</description>
        </group>
        <group group_id="E2">
          <title>Decision Support Tool</title>
          <description>This study will examine the efficacy of a web-based educational decision support tool.&#xD;
Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis</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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </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="61"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </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>Liana Fraenkel, MD, MPH, Department of Medicine</name_or_title>
      <organization>Yale University</organization>
      <email>liana.fraenkel@yale.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/NCT01721200
org study id: 2012-0294
secondary id: 12-003011
nct id: NCT01721200
lead sponsor: 
collaborator: 
has dmc: No
This study is a randomized controlled trial designed to examine the efficacy of an
      educational decision support tool for patients with rheumatoid arthritis who continue to have
      active disease despite use of traditional disease modifying drugs. The study will take place
      at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the
      treating physician and those providing consent will be randomized to usual care versus use of
      the decision support tool.
Data suggest that undertreatment of rheumatoid arthritis (RA) patients may be in part due to
      inadequate decision support when they face whether or not to start biologic therapy. No
      proven way exists to inform or support RA patients who are candidates for biologic therapy.
      Communicating information about biologic medication is particularly challenging because of
      the sheer number of risks to disclose, the difficulty explaining the risks of extremely rare
      adverse events (AEs), and the tendency for people to discount (or underweight) future
      benefits.

      Dr Liana Fraenkel at Yale University is the Primary Investigator and developer of this
      theory-based high quality decision support tool to effectively inform RA patients who are
      candidates for biologics. Dr. Eric Newman will be Principal Investigator for the project
      which will be conducted at Geisinger Medical Center. All subjects enrolled will complete a
      baseline survey and then will be randomized to use of the decision support tool or to usual
      care. Those randomized to usual care will be offered the opportunity to access the tool once
      enrollment is closed and all follow-up visits have been completed.

      Outcomes will be assessed at two and six weeks after the baseline visit by the Geisinger
      Telephone Survey and Interviewing Facility. This facility is equipped with 12 computers and
      runs two shifts a day. The Survey Unit uses a state-of-the-art Windows based Computer
      Assisted Telephone Interview (CATI) system to administer surveys and collect research data.
      The group holds 12 interviewer licenses for the CATI system. Trained and experienced
      interviewers are available to make the calls from 9 am to 9 pm Monday through Friday and from
      10 am to 2 pm on Saturdays.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks
time frame: 2 weeks
description: We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.
measure: Patient-physician Communication
time frame: 8 weeks
description: Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.
measure: Use of Biologics
time frame: 8 weeks
description: Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.
measure: To Test Screening and Recruitment Procedures
time frame: 8 weeks
description: To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.
measure: To Test Uptake
time frame: 8 weeks
description: To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.
measure: Acceptability to Physicians
time frame: 8 weeks
description: Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed:
Did the tool make it easier to talk about treatment with your patients?
Did the tool increase the amount of time you spent discussing therapy with your patients?
Did the tool decrease the amount of time you spent discussing therapy with your patients?
Did the tool improve the quality of informed consent for patients initiating biologics?
measure: To Test Adherence to the Intervention
time frame: 8 weeks
description: The session management system will record the time spent on each module visited within the tool to assess adherence.
measure: Changes in Knowledge
time frame: 8 weeks
description: Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.
measure: Changes in Willingness
time frame: 8 weeks
description: Willingness: Patients' propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by "Not willing at all" and "Extremely willing" with "Unsure" at the midpoint (65). Higher scores reflect greater willingness.
measure: Changes in Perceived Knowledge
time frame: 8 weeks
description: Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).
arm group label: Decision Support Tool
arm group type: Other
description: This study will examine the efficacy of a web-based educational decision support tool.
arm group label: Usual Care
arm group type: Other
description: Usual Care Group will receive their biologic drug teaching from their rheumatologist.
intervention type: Other
intervention name: Decision Support Tool
description: Educational decision support tool for patients with rheumatoid arthritis
arm group label: Decision Support Tool
intervention type: Other
intervention name: Usual Care
description: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Liana Fraenkel, MD, MPH
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
url: http://www.geisinger.org
description: Geisinger Health System
citation: Fraenkel L, Matzko CK, Webb DE, Oppermann B, Charpentier P, Peters E, Reyna V, Newman ED. Use of Decision Support for Improved Knowledge, Values Clarification, and Informed Choice in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov;67(11):1496-502. doi: 10.1002/acr.22659.
PMID: 26195173
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 