<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/NCT03023813</url>
  </required_header>
  <id_info>
    <org_study_id>16-854</org_study_id>
    <nct_id>NCT03023813</nct_id>
  </id_info>
  <brief_title>Individualizing Disease Prevention for Middle-Aged Adults</brief_title>
  <official_title>Individualizing Disease Prevention for Middle-Aged Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glen Taksler</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to help patients compare the benefits of various&#xD;
      preventive care services, based on their individual risk factors (such as smoking status,&#xD;
      obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be&#xD;
      provided to each participant during primary care appointments to facilitate discussion&#xD;
      between the participant and his/her provider regarding prioritizing preventive service&#xD;
      recommendations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated on 2/17/2021 due to on-going and uncertain nature of COVID-19 pandemic;&#xD;
    this was not a suspension of IRB approval.&#xD;
  </why_stopped>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">March 12, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2020</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>
    <intervention_model_description>Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Only the 2 arm round(s) will be randomized.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Interest in Individualized Preventive Care Recommendations.</measure>
    <time_frame>Within 3 days of index primary care appointment.</time_frame>
    <description>Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.&#xD;
Survey question: &quot;Overall, how helpful did you find the written materials (handouts)?&quot; Ten point scale (minimum 1, maximum 10, higher score is better outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interest in Individualized Preventive Care Recommendations.</measure>
    <time_frame>Within 3 days of index primary care appointment.</time_frame>
    <description>Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.&#xD;
Survey question: &quot;In the future, would you like to see updated written materials (handouts)?&quot; Ten point scale (minimum 1, maximum 10, higher score is better outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of Shared Decision Making.</measure>
    <time_frame>Within 3 days of index primary care appointment.</time_frame>
    <description>Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Readiness to Change Health Behaviors.</measure>
    <time_frame>Within 3 days of index primary care appointment.</time_frame>
    <description>Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Readiness to Change Health Behaviors</measure>
    <time_frame>Within 3 days of index primary care appointment</time_frame>
    <description>Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Readiness to Change Health Behaviors.</measure>
    <time_frame>Within 3 days of index primary care appointment</time_frame>
    <description>Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Readiness to Change Health Behaviors</measure>
    <time_frame>Within 3 days of index primary care appointment</time_frame>
    <description>Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Comfort.</measure>
    <time_frame>Within 3 days of index primary care appointment.</time_frame>
    <description>Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preventive Care Outcomes for Patients.</measure>
    <time_frame>Within 1 year of index primary care appointment.</time_frame>
    <description>Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Primary Health Care</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualized preventive care recommendations will be distributed to subjects.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Development Phase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-randomized receipt of individualized preventive care recommendations</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>Written material provided.</description>
    <arm_group_label>Development Phase</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for an appointment with primary care provider during study period&#xD;
&#xD;
          -  Two or more of the following risk factors:&#xD;
&#xD;
          -  Tobacco use&#xD;
&#xD;
          -  Overweight/obese&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Hyperlipidemia&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Alcohol Misuse&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  History of Sexually Transmitted Infection&#xD;
&#xD;
          -  Being overdue for the following screenings: Colorectal, cervical, breast, lung&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive&#xD;
        pulmonary disease, end stage renal disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glen Taksler, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Krist AH, Glenn BA, Glasgow RE, Balasubramanian BA, Chambers DA, Fernandez ME, Heurtin-Roberts S, Kessler R, Ory MG, Phillips SM, Ritzwoller DP, Roby DH, Rodriguez HP, Sabo RT, Sheinfeld Gorin SN, Stange KC; MOHR Study Group. Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project. Implement Sci. 2013 Jun 25;8:73. doi: 10.1186/1748-5908-8-73.</citation>
    <PMID>23799943</PMID>
  </reference>
  <reference>
    <citation>Glasgow RE, Kessler RS, Ory MG, Roby D, Gorin SS, Krist A. Conducting rapid, relevant research: lessons learned from the My Own Health Report project. Am J Prev Med. 2014 Aug;47(2):212-9. doi: 10.1016/j.amepre.2014.03.007. Epub 2014 Jun 18.</citation>
    <PMID>24953520</PMID>
  </reference>
  <reference>
    <citation>Edwards A, Elwyn G. Inside the black box of shared decision making: distinguishing between the process of involvement and who makes the decision. Health Expect. 2006 Dec;9(4):307-20. doi: 10.1111/j.1369-7625.2006.00401.x.</citation>
    <PMID>17083558</PMID>
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    <citation>Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003 Apr;12(2):93-9. doi: 10.1136/qhc.12.2.93.</citation>
    <PMID>12679504</PMID>
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    <citation>Nagykaldi Z, Aspy CB, Chou A, Mold JW. Impact of a Wellness Portal on the delivery of patient-centered preventive care. J Am Board Fam Med. 2012 Mar-Apr;25(2):158-67. doi: 10.3122/jabfm.2012.02.110130.</citation>
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    <citation>Sepucha KR, Fagerlin A, Couper MP, Levin CA, Singer E, Zikmund-Fisher BJ. How does feeling informed relate to being informed? The DECISIONS survey. Med Decis Making. 2010 Sep-Oct;30(5 Suppl):77S-84S. doi: 10.1177/0272989X10379647.</citation>
    <PMID>20881156</PMID>
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    <citation>Dillard AJ, Ferrer RA, Ubel PA, Fagerlin A. Risk perception measures' associations with behavior intentions, affect, and cognition following colon cancer screening messages. Health Psychol. 2012 Jan;31(1):106-13. doi: 10.1037/a0024787. Epub 2011 Aug 1.</citation>
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    <citation>Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.</citation>
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    <citation>Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.</citation>
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    <citation>Phillips SM, Glasgow RE, Bello G, Ory MG, Glenn BA, Sheinfeld-Gorin SN, Sabo RT, Heurtin-Roberts S, Johnson SB, Krist AH; MOHR Study Group. Frequency and prioritization of patient health risks from a structured health risk assessment. Ann Fam Med. 2014 Nov-Dec;12(6):505-13. doi: 10.1370/afm.1717.</citation>
    <PMID>25384812</PMID>
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    <citation>Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.</citation>
    <PMID>19879711</PMID>
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    <citation>Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: development of the Subjective Numeracy Scale. Med Decis Making. 2007 Sep-Oct;27(5):672-80. doi: 10.1177/0272989X07304449. Epub 2007 Jul 19.</citation>
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    <citation>Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of the Subjective Numeracy Scale: effects of low numeracy on comprehension of risk communications and utility elicitations. Med Decis Making. 2007 Sep-Oct;27(5):663-71. doi: 10.1177/0272989X07303824. Epub 2007 Jul 24.</citation>
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    <citation>Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, Fagerlin A. Presenting research risks and benefits to parents: does format matter? Anesth Analg. 2010 Sep;111(3):718-23. doi: 10.1213/ANE.0b013e3181e8570a. Epub 2010 Aug 4.</citation>
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    <citation>Tait AR, Zikmund-Fisher BJ, Fagerlin A, Voepel-Lewis T. Effect of various risk/benefit trade-offs on parents' understanding of a pediatric research study. Pediatrics. 2010 Jun;125(6):e1475-82. doi: 10.1542/peds.2009-1796. Epub 2010 May 10.</citation>
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    <citation>Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, Fagerlin A. The effect of format on parents' understanding of the risks and benefits of clinical research: a comparison between text, tables, and graphics. J Health Commun. 2010 Jul;15(5):487-501. doi: 10.1080/10810730.2010.492560.</citation>
    <PMID>20677054</PMID>
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    <citation>Lloyd A, Joseph-Williams N, Edwards A, Rix A, Elwyn G. Patchy 'coherence': using normalization process theory to evaluate a multi-faceted shared decision making implementation program (MAGIC). Implement Sci. 2013 Sep 5;8:102. doi: 10.1186/1748-5908-8-102.</citation>
    <PMID>24006959</PMID>
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    <PMID>22618581</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>March 29, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2021</results_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Glen Taksler</investigator_full_name>
    <investigator_title>Staff</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03023813/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03023813/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Usual care</description>
        </group>
        <group group_id="P3">
          <title>Development Phase</title>
          <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </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="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </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>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Usual care</description>
        </group>
        <group group_id="B3">
          <title>Development Phase</title>
          <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
        </group>
        <group group_id="B4">
          <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="38"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.9" lower_limit="53" upper_limit="59"/>
                    <measurement group_id="B2" value="56.6" lower_limit="53" upper_limit="61"/>
                    <measurement group_id="B3" value="56.9" lower_limit="53" upper_limit="61"/>
                    <measurement group_id="B4" value="56.5" lower_limit="53" upper_limit="61"/>
                  </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="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Practice site</title>
          <description>Study was conducted at 3 physical locations (primary care ambulatory clinics), denoted as Site 1, Site 2 or Site 3.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Site 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Less than high school</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school (diploma or GED)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Masters degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctoral or professional degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Married or civil/domestic partner</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Divorced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Separated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Interest in Individualized Preventive Care Recommendations.</title>
        <description>Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.&#xD;
Survey question: &quot;Overall, how helpful did you find the written materials (handouts)?&quot; Ten point scale (minimum 1, maximum 10, higher score is better outcome)</description>
        <time_frame>Within 3 days of index primary care appointment.</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Interest in Individualized Preventive Care Recommendations.</title>
          <description>Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.&#xD;
Survey question: &quot;Overall, how helpful did you find the written materials (handouts)?&quot; Ten point scale (minimum 1, maximum 10, higher score is better outcome)</description>
          <population>Patients who completed surveys</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Collected from intervention subjects only</measurement>
                    <measurement group_id="O3" value="9.0" lower_limit="8" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Interest in Individualized Preventive Care Recommendations.</title>
        <description>Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.&#xD;
Survey question: &quot;In the future, would you like to see updated written materials (handouts)?&quot; Ten point scale (minimum 1, maximum 10, higher score is better outcome)</description>
        <time_frame>Within 3 days of index primary care appointment.</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Interest in Individualized Preventive Care Recommendations.</title>
          <description>Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.&#xD;
Survey question: &quot;In the future, would you like to see updated written materials (handouts)?&quot; Ten point scale (minimum 1, maximum 10, higher score is better outcome)</description>
          <population>Patients who completed surveys</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="9" upper_limit="10"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Collected from intervention subjects only</measurement>
                    <measurement group_id="O3" value="9.0" lower_limit="9" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Shared Decision Making.</title>
        <description>Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)</description>
        <time_frame>Within 3 days of index primary care appointment.</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Shared Decision Making.</title>
          <description>Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)</description>
          <population>Patients who completed surveys</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.0" spread="4.6"/>
                    <measurement group_id="O2" value="74.3" spread="5.1"/>
                    <measurement group_id="O3" value="86.4" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.50</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Readiness to Change Health Behaviors.</title>
        <description>Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
        <time_frame>Within 3 days of index primary care appointment.</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Readiness to Change Health Behaviors.</title>
          <description>Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
          <population>Patients who completed surveys</population>
          <units>percentage of survey responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6" spread="7.2"/>
                    <measurement group_id="O2" value="70.8" spread="9.5"/>
                    <measurement group_id="O3" value="83.3" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.25</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Readiness to Change Health Behaviors</title>
        <description>Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
        <time_frame>Within 3 days of index primary care appointment</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Readiness to Change Health Behaviors</title>
          <description>Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
          <population>Patients who completed surveys</population>
          <units>percentage of survey responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" spread="7.8"/>
                    <measurement group_id="O2" value="72.7" spread="9.7"/>
                    <measurement group_id="O3" value="86.7" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>.39</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Readiness to Change Health Behaviors.</title>
        <description>Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
        <time_frame>Within 3 days of index primary care appointment</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Readiness to Change Health Behaviors.</title>
          <description>Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
          <population>Patients who completed surveys</population>
          <units>percentage of survey responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" spread="9.0"/>
                    <measurement group_id="O2" value="77.8" spread="10.1"/>
                    <measurement group_id="O3" value="78.6" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.59</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Readiness to Change Health Behaviors</title>
        <description>Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
        <time_frame>Within 3 days of index primary care appointment</time_frame>
        <population>Patients who completed surveys</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Readiness to Change Health Behaviors</title>
          <description>Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score &gt;=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower</description>
          <population>Patients who completed surveys</population>
          <units>percentage of survey responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.0" spread="10.7"/>
                    <measurement group_id="O2" value="69.2" spread="13.3"/>
                    <measurement group_id="O3" value="82.1" spread="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.53</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decisional Comfort.</title>
        <description>Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)</description>
        <time_frame>Within 3 days of index primary care appointment.</time_frame>
        <population>Patients who completed surveys (Data not collected for Development Phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</description>
          </group>
        </group_list>
        <measure>
          <title>Decisional Comfort.</title>
          <description>Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)</description>
          <population>Patients who completed surveys (Data not collected for Development Phase)</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" spread="5.3"/>
                    <measurement group_id="O2" value="72.3" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.91</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preventive Care Outcomes for Patients.</title>
        <description>Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.</description>
        <time_frame>Within 1 year of index primary care appointment.</time_frame>
        <population>Outcome tables are not included for specific preventive services because outcomes were not assessed by arm (instead, a statistical regression strategy was used).&#xD;
This outcome was not collected for participants in the Development arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Usual care</description>
          </group>
          <group group_id="O3">
            <title>Development Phase</title>
            <description>Non-randomized receipt of individualized preventive care recommendations</description>
          </group>
        </group_list>
        <measure>
          <title>Preventive Care Outcomes for Patients.</title>
          <description>Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.</description>
          <population>Outcome tables are not included for specific preventive services because outcomes were not assessed by arm (instead, a statistical regression strategy was used).&#xD;
This outcome was not collected for participants in the Development arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included weight loss</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Percent change in weight (lbs.) since the baseline encounter</non_inferiority_desc>
            <p_value>0.27</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-2.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.18</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
            <estimate_desc>Result for intervention arm minus control arm</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included blood pressure control</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Change in systolic blood pressure since the baseline encounter (mmHg)</non_inferiority_desc>
            <p_value>0.19</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-6.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.12</ci_lower_limit>
            <ci_upper_limit>3.27</ci_upper_limit>
            <estimate_desc>Result for intervention arm minus control arm</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included glycemic control</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Percentage point change in HbA1c (%) since the baseline encounter</non_inferiority_desc>
            <p_value>0.24</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.82</ci_lower_limit>
            <ci_upper_limit>0.45</ci_upper_limit>
            <estimate_desc>Result for intervention arm minus control arm</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included lipids control</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter</non_inferiority_desc>
            <p_value>0.34</p_value>
            <method>Generalized linear mixed regression</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.65</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
            <estimate_desc>Result for intervention arm minus control arm</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included lipids control</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter</non_inferiority_desc>
            <p_value>0.36</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-8.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.63</ci_lower_limit>
            <ci_upper_limit>9.70</ci_upper_limit>
            <estimate_desc>Result for intervention arm minus control arm</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included tobacco cessation</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter.</non_inferiority_desc>
            <p_value>0.92</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Generalized linear mixed regression with logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>45.56</ci_upper_limit>
            <estimate_desc>Result for intervention arm relative to control arm. OR &lt;1 indicates reduction in smoking intensity; OR &gt;1 indicates increase in smoking intensity.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Among participants whose individualized preventive care recommendations included colorectal cancer screening</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Receipt of colorectal cancer screening since the baseline encounter</non_inferiority_desc>
            <p_value>0.99</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Generalized linear mixed regression with logit link</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.001</ci_lower_limit>
            <ci_upper_limit>1000</ci_upper_limit>
            <estimate_desc>Result for intervention arm relative to control arm. Lower limit estimate was &lt;0.001 and upper limit estimate was &gt;1000 (ClinicalTrials.gov does not allow &lt; or &gt; to be entered into the confidence interval lower limit or upper limit fields).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 1 year following enrollment of each patient participant.</time_frame>
      <desc>As an Institutional Review Board (IRB)-determined minimal risk study, adverse events were not tracked by the study team. Instead, participants were asked to report any adverse events to the study team or the IRB. No events were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Individualized preventive care recommendations will be distributed to subjects.&#xD;
Intervention: Written material provided.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Usual care</description>
        </group>
        <group group_id="E3">
          <title>Development Phase</title>
          <description>Non-randomized receipt of individualized preventive care recommendations&#xD;
Intervention: Written material provided.</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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
              </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>Glen Taksler PhD</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-445-7499</phone>
      <email>taksleg@ccf.org</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/NCT03023813
org study id: 16-854
nct id: NCT03023813
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to help patients compare the benefits of various
      preventive care services, based on their individual risk factors (such as smoking status,
      obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be
      provided to each participant during primary care appointments to facilitate discussion
      between the participant and his/her provider regarding prioritizing preventive service
      recommendations.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.
primary purpose: Prevention
masking: None (Open Label)
masking description: Only the 2 arm round(s) will be randomized.
measure: Interest in Individualized Preventive Care Recommendations.
time frame: Within 3 days of index primary care appointment.
description: Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.
Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)
measure: Interest in Individualized Preventive Care Recommendations.
time frame: Within 3 days of index primary care appointment.
description: Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.
Survey question: "In the future, would you like to see updated written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)
measure: Use of Shared Decision Making.
time frame: Within 3 days of index primary care appointment.
description: Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)
measure: Patient Readiness to Change Health Behaviors.
time frame: Within 3 days of index primary care appointment.
description: Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
measure: Patient Readiness to Change Health Behaviors
time frame: Within 3 days of index primary care appointment
description: Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
measure: Patient Readiness to Change Health Behaviors.
time frame: Within 3 days of index primary care appointment
description: Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
measure: Patient Readiness to Change Health Behaviors
time frame: Within 3 days of index primary care appointment
description: Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower
measure: Decisional Comfort.
time frame: Within 3 days of index primary care appointment.
description: Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)
measure: Preventive Care Outcomes for Patients.
time frame: Within 1 year of index primary care appointment.
description: Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.
arm group label: Intervention
arm group type: Experimental
description: Individualized preventive care recommendations will be distributed to subjects.
arm group label: Control
arm group type: No Intervention
description: Usual care
arm group label: Development Phase
arm group type: Experimental
description: Non-randomized receipt of individualized preventive care recommendations
intervention type: Other
intervention name: Intervention
description: Written material provided.
arm group label: Development Phase
arm group label: Intervention
criteria: 
gender: All
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Glen Taksler, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
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PMID: 23799943
citation: Glasgow RE, Kessler RS, Ory MG, Roby D, Gorin SS, Krist A. Conducting rapid, relevant research: lessons learned from the My Own Health Report project. Am J Prev Med. 2014 Aug;47(2):212-9. doi: 10.1016/j.amepre.2014.03.007. Epub 2014 Jun 18.
PMID: 24953520
citation: Edwards A, Elwyn G. Inside the black box of shared decision making: distinguishing between the process of involvement and who makes the decision. Health Expect. 2006 Dec;9(4):307-20. doi: 10.1111/j.1369-7625.2006.00401.x.
PMID: 17083558
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citation: Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns. 2008 Dec;73(3):448-55. doi: 10.1016/j.pec.2008.07.023. Epub 2008 Aug 27.
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citation: Lloyd A, Joseph-Williams N, Edwards A, Rix A, Elwyn G. Patchy 'coherence': using normalization process theory to evaluate a multi-faceted shared decision making implementation program (MAGIC). Implement Sci. 2013 Sep 5;8:102. doi: 10.1186/1748-5908-8-102.
PMID: 24006959
citation: Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.
PMID: 22618581
responsible party type: Sponsor-Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Glen Taksler
investigator title: Staff
sharing ipd: No
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