<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/NCT03802825</url>
  </required_header>
  <id_info>
    <org_study_id>1R34DK119853-01</org_study_id>
    <nct_id>NCT03802825</nct_id>
  </id_info>
  <brief_title>Addressing Social Determinants of Health &amp; Diabetes Self-Management in Vulnerable Populations</brief_title>
  <official_title>Addressing Social Determinants of Health &amp; Diabetes Self-Management in Vulnerable Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</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>
      In this pilot and feasibility study, the investigator will randomize 100 African-American,&#xD;
      Hispanic, and/or Medicaid (all race/ethnicities) patients from KPNW with A1C ≥ 8 to one of&#xD;
      two 6-month interventions: 1) patient navigation only; or 2) patient navigation + diabetes&#xD;
      self-management training. Feasibility of a large-scale, pragmatic, randomized trial will be&#xD;
      determined and preliminary effectiveness of treatment arms on A1C reduction among&#xD;
      racial/ethnic minority and low-income patients with poorly managed diabetes will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this feasibility study is to inform the design of a future large-scale,&#xD;
      randomized trial that will test if there is added benefit to addressing both social and&#xD;
      economic needs and diabetes self-management to improve diabetes management long-term among&#xD;
      vulnerable populations. In this pilot, the investigator will randomize 100 African-American,&#xD;
      Hispanic, and/or Medicaid (all race/ethnicities) patients from Kaiser Permanente Northwest&#xD;
      (KPNW) with A1C ≥ 8 and poor follow-up in primary care to one of two 6-month interventions:&#xD;
      1) patient navigation only; or 2) patient navigation + diabetes self-management training. In&#xD;
      both study arms, KPNW practice-embedded patient navigators will screen for medical, social&#xD;
      and economic needs and connect participants to internal and external resources. In the second&#xD;
      study arm, navigators will also refer participants to community health workers (CHWs)&#xD;
      embedded in local community-based organizations, who will deliver diabetes self-management&#xD;
      training. Feasibility of the full-scale trial will be based on several measures including&#xD;
      recruitment, retention, success rate of referrals to navigators and CHWs, and whether&#xD;
      medical, social, and/or economic needs are met. Qualitative interviews will be conducted with&#xD;
      various stakeholders to assess intervention acceptability and determinants of implementation.&#xD;
      Preliminary effects of A1C, diabetes-related care gaps, health care utilization, and&#xD;
      medication adherence will also be examined. This pragmatic study design involves a&#xD;
      collaborative effort among researchers, health system staff, health system senior leadership,&#xD;
      and local community-based organizations. Findings from the full-scale trial will contribute&#xD;
      critical knowledge on the most effective, sustainable model of care for integrating lay&#xD;
      health workers in the efforts to improve diabetes management among high risk patient&#xD;
      populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Eligibility criteria for all study participants is a diagnosis of diabetes with A1C ≥ 8.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of Participants With A1C &lt; 8%</measure>
    <time_frame>6 months</time_frame>
    <description>Using ITT analysis, percent of participants in each arm with A1C &lt; 8% at 6-month follow-up was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency Department (ED) Visits</measure>
    <time_frame>6 months</time_frame>
    <description>Mean number of visits to the emergency department over the 6-month duration of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary Care Visit No-show Rate</measure>
    <time_frame>6 months</time_frame>
    <description>Mean number of missed primary care visits over duration of the intervention (6 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Refills</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants with 1 or more gaps in refilling oral diabetes medications during the study period. A gap is defined as not refilling prescription for 7 or more days after prescription has ran out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean A1C Change</measure>
    <time_frame>6 months</time_frame>
    <description>Change in A1C from baseline to 6-month follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Patient Navigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Navigation+Diabetes Self-Management Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to receiving patient navigation as described, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.&#xD;
The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes Self-Management Training</intervention_name>
    <description>The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contact with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
    <arm_group_label>Patient Navigation+Diabetes Self-Management Support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Patient Navigation</intervention_name>
    <description>Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
    <arm_group_label>Patient Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes diagnosis&#xD;
&#xD;
          -  Current Kaiser Permanente Northwest member&#xD;
&#xD;
          -  African-American, Hispanic/Latino (English, Spanish-speaking, or bilingual), and/or a&#xD;
             Medicaid recipient (from any racial or ethnic background)&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Most recent hemoglobin A1C test of ≥ 8&#xD;
&#xD;
          -  Endorses 1 or more social and/or economic need on the Your Current Life Situation&#xD;
             assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unable to provide informed consent due to cognitive or psychiatric&#xD;
             impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie L Fitzpatrick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Northwest</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Papajorgji-Taylor D, Francisco M, Schneider JL, Vaughn K, Lindberg N, Smith N, Fitzpatrick SL. Bridge to Health/ Puente a la Salud: Rationale and design of a pilot feasibility randomized trial to address diabetes self-management and unmet basic needs among racial/ethnic minority and low-income patients. Contemp Clin Trials Commun. 2021 Apr 30;22:100779. doi: 10.1016/j.conctc.2021.100779. eCollection 2021 Jun.</citation>
    <PMID>34013093</PMID>
  </reference>
  <results_reference>
    <citation>Fitzpatrick SL, Papajorgji-Taylor D, Schneider JL, Lindberg N, Francisco M, Smith N, Vaughn K, Vrany EA, Hill-Briggs F. Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients. Transl Behav Med. 2022 Jul 18;12(7):783-792. doi: 10.1093/tbm/ibac016.</citation>
    <PMID>35849138</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <results_first_submitted>August 3, 2022</results_first_submitted>
  <results_first_submitted_qc>November 4, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2022</results_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03802825/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03802825/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>We used a targeted recruitment approach by first identifying potentially eligible patients in the electronic health record (EHR) and then emailing or mailing recruitment letters. Letters were followed by a phone call from study staff who described the study and further assessed eligibility by confirming race/ethnicity and health coverage and administering a social risks screener.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Patient Navigation</title>
          <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
        </group>
        <group group_id="P2">
          <title>Patient Navigation+Diabetes Self-Management Support</title>
          <description>In addition to receiving navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.&#xD;
The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to follow-up for intervention</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received only 1 component of intervention</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patient Navigation</title>
          <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
        </group>
        <group group_id="B2">
          <title>Patient Navigation+Diabetes Self-Management Support</title>
          <description>In addition to receiving navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.&#xD;
The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</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="54"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="110"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.9" spread="12.1"/>
                    <measurement group_id="B2" value="53.7" spread="12.1"/>
                    <measurement group_id="B3" value="53.3" spread="12"/>
                  </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="38"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple Races</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="38"/>
                  </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="54"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Language</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>English</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spanish</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>A1C</title>
          <units>% of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.9" spread="1.7"/>
                    <measurement group_id="B2" value="9.8" spread="1.6"/>
                    <measurement group_id="B3" value="9.9" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Types of Social Needs Reported</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Insufficient Housing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Financial Hardship</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Food Insecurity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of Transportation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent of Participants With A1C &lt; 8%</title>
        <description>Using ITT analysis, percent of participants in each arm with A1C &lt; 8% at 6-month follow-up was calculated.</description>
        <time_frame>6 months</time_frame>
        <population>ITT was used for primary outcome analysis so all participants included.</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
          </group>
          <group group_id="O2">
            <title>Patient Navigation+Diabetes Self-Management Support</title>
            <description>In addition to receiving patient navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.&#xD;
The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With A1C &lt; 8%</title>
          <description>Using ITT analysis, percent of participants in each arm with A1C &lt; 8% at 6-month follow-up was calculated.</description>
          <population>ITT was used for primary outcome analysis so all participants included.</population>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Emergency Department (ED) Visits</title>
        <description>Mean number of visits to the emergency department over the 6-month duration of the intervention.</description>
        <time_frame>6 months</time_frame>
        <population>Analysis for this secondary outcome includes all participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
          </group>
          <group group_id="O2">
            <title>Patient Navigation+Diabetes Self-Management Support</title>
            <description>In addition to receiving patient navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
          </group>
        </group_list>
        <measure>
          <title>Emergency Department (ED) Visits</title>
          <description>Mean number of visits to the emergency department over the 6-month duration of the intervention.</description>
          <population>Analysis for this secondary outcome includes all participants.</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="1.70"/>
                    <measurement group_id="O2" value="1.07" spread="2.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Primary Care Visit No-show Rate</title>
        <description>Mean number of missed primary care visits over duration of the intervention (6 months)</description>
        <time_frame>6 months</time_frame>
        <population>All participants were included in the analysis for this secondary outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
          </group>
          <group group_id="O2">
            <title>Patient Navigation+Diabetes Self-Management Support</title>
            <description>In addition to receiving patient navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Care Visit No-show Rate</title>
          <description>Mean number of missed primary care visits over duration of the intervention (6 months)</description>
          <population>All participants were included in the analysis for this secondary outcome.</population>
          <units>missed visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="1.29"/>
                    <measurement group_id="O2" value="0.88" spread="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Refills</title>
        <description>Number of participants with 1 or more gaps in refilling oral diabetes medications during the study period. A gap is defined as not refilling prescription for 7 or more days after prescription has ran out.</description>
        <time_frame>6 months</time_frame>
        <population>Participants who were prescribed an oral diabetes medication during the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
          </group>
          <group group_id="O2">
            <title>Patient Navigation+Diabetes Self-Management Support</title>
            <description>In addition to receiving patient navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Refills</title>
          <description>Number of participants with 1 or more gaps in refilling oral diabetes medications during the study period. A gap is defined as not refilling prescription for 7 or more days after prescription has ran out.</description>
          <population>Participants who were prescribed an oral diabetes medication during the study.</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="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean A1C Change</title>
        <description>Change in A1C from baseline to 6-month follow-up</description>
        <time_frame>6 months</time_frame>
        <population>ITT analysis was used for this outcome, so all participants were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Navigation</title>
            <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
          </group>
          <group group_id="O2">
            <title>Patient Navigation+Diabetes Self-Management Support</title>
            <description>In addition to receiving patient navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean A1C Change</title>
          <description>Change in A1C from baseline to 6-month follow-up</description>
          <population>ITT analysis was used for this outcome, so all participants were included in the analysis.</population>
          <units>percentage of glycosylated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="1.76"/>
                    <measurement group_id="O2" value="0.72" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over 6 months for each participant; 2 years total for the overall study period.</time_frame>
      <desc>Adverse events were tracked using data from the electronic health record and based on the following events: hospitalizations, death, and hypoglycemia.</desc>
      <group_list>
        <group group_id="E1">
          <title>Patient Navigation</title>
          <description>Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.&#xD;
Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.</description>
        </group>
        <group group_id="E2">
          <title>Patient Navigation+Diabetes Self-Management Support</title>
          <description>In addition to receiving patient navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity. The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.&#xD;
Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalizations</sub_title>
                <description>If participants were hospitalized for any reasons related to having diabetes, then this was tracked as a serious adverse event.</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <description>If a participant had a diagnosis of hypoglycemia (low blood sugar) for any medical encounter that occurred during the study period was considered a serious adverse event.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="54"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
              </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="54"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
              </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>Dr. Stephanie L. Fitzpatrick, Senior Investigator</name_or_title>
      <organization>Kaiser Permanente Center for Health Research</organization>
      <phone>502-345-1476</phone>
      <email>Stephanie.L.Fitzpatrick@kpchr.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/NCT03802825
org study id: 1R34DK119853-01
nct id: NCT03802825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this pilot and feasibility study, the investigator will randomize 100 African-American,
      Hispanic, and/or Medicaid (all race/ethnicities) patients from KPNW with A1C ≥ 8 to one of
      two 6-month interventions: 1) patient navigation only; or 2) patient navigation + diabetes
      self-management training. Feasibility of a large-scale, pragmatic, randomized trial will be
      determined and preliminary effectiveness of treatment arms on A1C reduction among
      racial/ethnic minority and low-income patients with poorly managed diabetes will be examined.
The purpose of this feasibility study is to inform the design of a future large-scale,
      randomized trial that will test if there is added benefit to addressing both social and
      economic needs and diabetes self-management to improve diabetes management long-term among
      vulnerable populations. In this pilot, the investigator will randomize 100 African-American,
      Hispanic, and/or Medicaid (all race/ethnicities) patients from Kaiser Permanente Northwest
      (KPNW) with A1C ≥ 8 and poor follow-up in primary care to one of two 6-month interventions:
      1) patient navigation only; or 2) patient navigation + diabetes self-management training. In
      both study arms, KPNW practice-embedded patient navigators will screen for medical, social
      and economic needs and connect participants to internal and external resources. In the second
      study arm, navigators will also refer participants to community health workers (CHWs)
      embedded in local community-based organizations, who will deliver diabetes self-management
      training. Feasibility of the full-scale trial will be based on several measures including
      recruitment, retention, success rate of referrals to navigators and CHWs, and whether
      medical, social, and/or economic needs are met. Qualitative interviews will be conducted with
      various stakeholders to assess intervention acceptability and determinants of implementation.
      Preliminary effects of A1C, diabetes-related care gaps, health care utilization, and
      medication adherence will also be examined. This pragmatic study design involves a
      collaborative effort among researchers, health system staff, health system senior leadership,
      and local community-based organizations. Findings from the full-scale trial will contribute
      critical knowledge on the most effective, sustainable model of care for integrating lay
      health workers in the efforts to improve diabetes management among high risk patient
      populations.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligibility criteria for all study participants is a diagnosis of diabetes with A1C ≥ 8.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percent of Participants With A1C < 8%
time frame: 6 months
description: Using ITT analysis, percent of participants in each arm with A1C < 8% at 6-month follow-up was calculated.
measure: Emergency Department (ED) Visits
time frame: 6 months
description: Mean number of visits to the emergency department over the 6-month duration of the intervention.
measure: Primary Care Visit No-show Rate
time frame: 6 months
description: Mean number of missed primary care visits over duration of the intervention (6 months)
measure: Medication Refills
time frame: 6 months
description: Number of participants with 1 or more gaps in refilling oral diabetes medications during the study period. A gap is defined as not refilling prescription for 7 or more days after prescription has ran out.
measure: Mean A1C Change
time frame: 6 months
description: Change in A1C from baseline to 6-month follow-up
arm group label: Patient Navigation
arm group type: Active Comparator
description: Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials.
arm group label: Patient Navigation+Diabetes Self-Management Support
arm group type: Experimental
description: In addition to receiving patient navigation as described, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity.
The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant.
intervention type: Behavioral
intervention name: Diabetes Self-Management Training
description: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contact with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.
arm group label: Patient Navigation+Diabetes Self-Management Support
intervention type: Other
intervention name: Standard Patient Navigation
description: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.
arm group label: Patient Navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephanie L Fitzpatrick, PhD
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
country: United States
citation: Papajorgji-Taylor D, Francisco M, Schneider JL, Vaughn K, Lindberg N, Smith N, Fitzpatrick SL. Bridge to Health/ Puente a la Salud: Rationale and design of a pilot feasibility randomized trial to address diabetes self-management and unmet basic needs among racial/ethnic minority and low-income patients. Contemp Clin Trials Commun. 2021 Apr 30;22:100779. doi: 10.1016/j.conctc.2021.100779. eCollection 2021 Jun.
PMID: 34013093
citation: Fitzpatrick SL, Papajorgji-Taylor D, Schneider JL, Lindberg N, Francisco M, Smith N, Vaughn K, Vrany EA, Hill-Briggs F. Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients. Transl Behav Med. 2022 Jul 18;12(7):783-792. doi: 10.1093/tbm/ibac016.
PMID: 35849138
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No
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