xml: <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/NCT05979987</url>
    </required_header>
    <id_info>
      <org_study_id>MAPreminder3</org_study_id>
      <nct_id>NCT05979987</nct_id>
    </id_info>
    <brief_title>UCLA Health Patient Health Maintenance Text Reminder July 2023</brief_title>
    <official_title>UCLA Health Patient Health Maintenance Text Reminder July 2023</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>UCLA Health Department of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, Los Angeles</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach&#xD;
        text message reminders impact patient engagement with primary care. This prospective&#xD;
        randomized control trial is being implemented in conjunction with UCLA Health's larger&#xD;
        quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order&#xD;
        to improve primary care preventive measure completion rates.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        UCLA Health will launch an initiative called My Action Plan which is an outreach effort&#xD;
        targeting the primary care patients at UCLA who have an outstanding, clinically indicated&#xD;
        primary care preventative care gap (e.g., overdue colorectal cancer screening, outstanding&#xD;
        diabetes tests) and aims at encouraging patients to complete their overdue health maintenance&#xD;
        measures.&#xD;
  &#xD;
        At the beginning of each month, identified UCLA Health primary care patients will be enrolled&#xD;
        in a trial the investigators have pre-registered under the title &quot;UCLA Health Patient Health&#xD;
        Maintenance Outreach Text Message&quot; and randomized to receive one of four text messages&#xD;
        informing them that they have overdue health maintenance measures and urging them to take&#xD;
        action to complete these measures. These text messages will contain a link to their MyChart&#xD;
        patient portal account, specifically linking them to a My Action Plan electronic letter that&#xD;
        will contain a personalized list of outstanding preventive care items and actionable steps to&#xD;
        complete the items.&#xD;
  &#xD;
        In July 2023, if participants do not open their My Action Plan electronic letter within 7&#xD;
        days after the initial outreach, they will be enrolled in the trial described in the current&#xD;
        pre-registration. Patients will be randomly assigned in a 1:1:1:1 ratio to receive one of&#xD;
        four text reminders 2 weeks after the initial outreach message. Additionally, within each&#xD;
        text-reminder arm, patients will be randomized to one of three time slots for getting the&#xD;
        reminder. The investigators will examine patients' interaction with these reminders and how&#xD;
        that ultimately translates to them completing their indicated health maintenance measures.&#xD;
  &#xD;
        The UCLA Department of Medicine (DOM) intends to roll out this QI initiative at the beginning&#xD;
        of the 2023 calendar year and continue it for a span of at least 12 months. Each month, the&#xD;
        initiative targets patients whose birthday falls into that month. This proposed trial will&#xD;
        run for one month (July 2023).&#xD;
  &#xD;
        Analysis Plan:&#xD;
  &#xD;
        The investigators will utilize patient-level ordinary least squares (OLS) estimation, with&#xD;
        statistical inferences based on model-robust standard errors. The primary model term will be&#xD;
        indicator variables for arm assignment.&#xD;
  &#xD;
        The analysis will adjust for sex, age, race/ethnicity, indicators for screenings/tests that&#xD;
        patients are due for, and whether patients have upcoming primary care appointments. Missing&#xD;
        covariate values will be handled by including 'unknown' indicators, along with mean&#xD;
        imputation for quantitative covariates.&#xD;
  &#xD;
        The investigators will first compare Arm 2 with Arm 1 to test the effect of encouraging&#xD;
        patients to read the story about a patient whose life was saved by preventive screening.. If&#xD;
        the difference is significant in an outcome measure, the investigators will then compare Arms&#xD;
        3 and 4 with Arms 1 and 2 to shed light on why Arm 2 differs from Arm 1.&#xD;
  &#xD;
        Exploratory analyses will investigate heterogeneous treatment effects of Arm 2 (vs. Arm 1) by&#xD;
        patients' gender, age, race/ethnicity, history of cancer and other pre-existing conditions,&#xD;
        family cancer history, past adherence to screenings/tests that are included in the My Action&#xD;
        Plan Initiative, past receipt of influenza vaccination, frequency of doctor visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>Parallel-arm randomized control trial</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Opening link within SMS Text message</measure>
      <time_frame>1 week after getting the reminder</time_frame>
      <description>Percentage of participants across the different reminder arms who click on the link in the reminder message</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>MyChart letter opened</measure>
      <time_frame>1 week after getting the reminder</time_frame>
      <description>Percentage of participants across the different arms who open their personalized My Action Plan letter on MyChart</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Direct scheduling appointment rate</measure>
      <time_frame>2 weeks after getting the reminder</time_frame>
      <description>Rate of which eligible participants directly schedule an appointment for diabetic retinal exams, diabetes education, or breast cancer screening in order to complete these overdue screening/test(s). These screenings/tests have dedicated appointment resources that people can directly schedule for.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of taking action for one overdue screening/test</measure>
      <time_frame>2 weeks after getting the reminder</time_frame>
      <description>Rate of which participants schedule an appointment to complete their overdue screening/test or start the online tool for colorectal screening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completion rate of one screening/test</measure>
      <time_frame>6 months after getting the initial outreach text message</time_frame>
      <description>Rate of completion of at least one screening/test within the observation window.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Health Maintenance</condition>
    <condition>Diabetes</condition>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Control Reminder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eligible, randomized participants will receive a generic text message reminding them to close their outstanding health gap.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Anecdote-based Reminder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eligible, randomized participants will receive a text message reminding them to close their outstanding health gap. This message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message prompts patients to click on a link to read the story about the patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Anecdote-based Reminder without link</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eligible, randomized participants will receive a text message reminding them to close their outstanding health gap. This message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message won't contain a link to the story, but it will briefly describe the story.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Research-based Reminder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eligible, randomized participants will receive a text message reminding them to close their outstanding health gap. This message will mention that research has shown promptly closing health gaps saves lives. The message will contain a link to an official website that supports the statement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Reminder of preventive care measures</intervention_name>
      <description>The investigators will send randomized participants an SMS reminder encouraging them to click the provided link and close their outstanding, overdue preventive care measures.&#xD;
  The provided link will take them to their MyChart login page; after logging in, they would see their personalized My Action Plan Letter detailing their personalized, overdue preventive care measures.</description>
      <arm_group_label>Anecdote-based Reminder</arm_group_label>
      <arm_group_label>Anecdote-based Reminder without link</arm_group_label>
      <arm_group_label>Control Reminder</arm_group_label>
      <arm_group_label>Research-based Reminder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Persuasion via anecdote</intervention_name>
      <description>The message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message prompts patients to click on a link to read the story about the patient.</description>
      <arm_group_label>Anecdote-based Reminder</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Persuasion via anecdote without link</intervention_name>
      <description>The message will contain a link to an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message won't contain a link to the story, but it will briefly describe the story.</description>
      <arm_group_label>Anecdote-based Reminder without link</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Persuasion via research</intervention_name>
      <description>This message will mention that research has shown promptly closing health gaps saves lives.The message will contain a link to an official website that supports the statement.</description>
      <arm_group_label>Research-based Reminder</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Empaneled to UCLA Health DOM Primary Care&#xD;
  &#xD;
            2. Has at least one overdue health maintenance measure that the My Action Plan initiative&#xD;
               focuses on&#xD;
  &#xD;
            3. Has an active MyChart status&#xD;
  &#xD;
            4. Can accept SMS messages from UCLA Health&#xD;
  &#xD;
            5. Has not opened the My Action Plan electronic letter within 7 days of initial outreach&#xD;
  &#xD;
            6. Has a July Birthday&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Under the age of 18&#xD;
  &#xD;
            2. Deceased patients&#xD;
  &#xD;
            3. Hospice patients&#xD;
  &#xD;
            4. Has opted out electronic communication (bulk messages, email, and/or text)&#xD;
  &#xD;
            5. For the final analysis, the investigators will further exclude patients who have&#xD;
               scheduled appointments for all screenings/tests or completed all screenings/tests&#xD;
               prior to the date when they are supposed to receive the reminder from this trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>UCLA Health Department of Medicine, Quality Office</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Richard K. Leuchter, MD</investigator_full_name>
      <investigator_title>Clinical Instructor of Medicine</investigator_title>
    </responsible_party>
    <keyword>primary care</keyword>
    <keyword>digital outreach</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We do not plan to make any individual participant data available.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979987
  org study id: MAPreminder3
  nct id: NCT05979987
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective randomized clinical trial evaluating how behaviorally-informed outreach
        text message reminders impact patient engagement with primary care. This prospective
        randomized control trial is being implemented in conjunction with UCLA Health's larger
        quality improvement initiative (the My Action Plan Quality Improvement Initiative) in order
        to improve primary care preventive measure completion rates.
  UCLA Health will launch an initiative called My Action Plan which is an outreach effort
        targeting the primary care patients at UCLA who have an outstanding, clinically indicated
        primary care preventative care gap (e.g., overdue colorectal cancer screening, outstanding
        diabetes tests) and aims at encouraging patients to complete their overdue health maintenance
        measures.
  
        At the beginning of each month, identified UCLA Health primary care patients will be enrolled
        in a trial the investigators have pre-registered under the title "UCLA Health Patient Health
        Maintenance Outreach Text Message" and randomized to receive one of four text messages
        informing them that they have overdue health maintenance measures and urging them to take
        action to complete these measures. These text messages will contain a link to their MyChart
        patient portal account, specifically linking them to a My Action Plan electronic letter that
        will contain a personalized list of outstanding preventive care items and actionable steps to
        complete the items.
  
        In July 2023, if participants do not open their My Action Plan electronic letter within 7
        days after the initial outreach, they will be enrolled in the trial described in the current
        pre-registration. Patients will be randomly assigned in a 1:1:1:1 ratio to receive one of
        four text reminders 2 weeks after the initial outreach message. Additionally, within each
        text-reminder arm, patients will be randomized to one of three time slots for getting the
        reminder. The investigators will examine patients' interaction with these reminders and how
        that ultimately translates to them completing their indicated health maintenance measures.
  
        The UCLA Department of Medicine (DOM) intends to roll out this QI initiative at the beginning
        of the 2023 calendar year and continue it for a span of at least 12 months. Each month, the
        initiative targets patients whose birthday falls into that month. This proposed trial will
        run for one month (July 2023).
  
        Analysis Plan:
  
        The investigators will utilize patient-level ordinary least squares (OLS) estimation, with
        statistical inferences based on model-robust standard errors. The primary model term will be
        indicator variables for arm assignment.
  
        The analysis will adjust for sex, age, race/ethnicity, indicators for screenings/tests that
        patients are due for, and whether patients have upcoming primary care appointments. Missing
        covariate values will be handled by including 'unknown' indicators, along with mean
        imputation for quantitative covariates.
  
        The investigators will first compare Arm 2 with Arm 1 to test the effect of encouraging
        patients to read the story about a patient whose life was saved by preventive screening.. If
        the difference is significant in an outcome measure, the investigators will then compare Arms
        3 and 4 with Arms 1 and 2 to shed light on why Arm 2 differs from Arm 1.
  
        Exploratory analyses will investigate heterogeneous treatment effects of Arm 2 (vs. Arm 1) by
        patients' gender, age, race/ethnicity, history of cancer and other pre-existing conditions,
        family cancer history, past adherence to screenings/tests that are included in the My Action
        Plan Initiative, past receipt of influenza vaccination, frequency of doctor visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel-arm randomized control trial
  primary purpose: Health Services Research
  masking: Double (Participant, Care Provider)
  measure: Opening link within SMS Text message
  time frame: 1 week after getting the reminder
  description: Percentage of participants across the different reminder arms who click on the link in the reminder message
  measure: MyChart letter opened
  time frame: 1 week after getting the reminder
  description: Percentage of participants across the different arms who open their personalized My Action Plan letter on MyChart
  measure: Direct scheduling appointment rate
  time frame: 2 weeks after getting the reminder
  description: Rate of which eligible participants directly schedule an appointment for diabetic retinal exams, diabetes education, or breast cancer screening in order to complete these overdue screening/test(s). These screenings/tests have dedicated appointment resources that people can directly schedule for.
  measure: Rate of taking action for one overdue screening/test
  time frame: 2 weeks after getting the reminder
  description: Rate of which participants schedule an appointment to complete their overdue screening/test or start the online tool for colorectal screening
  measure: Completion rate of one screening/test
  time frame: 6 months after getting the initial outreach text message
  description: Rate of completion of at least one screening/test within the observation window.
  arm group label: Control Reminder
  arm group type: Experimental
  description: Eligible, randomized participants will receive a generic text message reminding them to close their outstanding health gap.
  arm group label: Anecdote-based Reminder
  arm group type: Experimental
  description: Eligible, randomized participants will receive a text message reminding them to close their outstanding health gap. This message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message prompts patients to click on a link to read the story about the patient.
  arm group label: Anecdote-based Reminder without link
  arm group type: Experimental
  description: Eligible, randomized participants will receive a text message reminding them to close their outstanding health gap. This message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message won't contain a link to the story, but it will briefly describe the story.
  arm group label: Research-based Reminder
  arm group type: Experimental
  description: Eligible, randomized participants will receive a text message reminding them to close their outstanding health gap. This message will mention that research has shown promptly closing health gaps saves lives. The message will contain a link to an official website that supports the statement.
  intervention type: Behavioral
  intervention name: Reminder of preventive care measures
  description: The investigators will send randomized participants an SMS reminder encouraging them to click the provided link and close their outstanding, overdue preventive care measures.
  The provided link will take them to their MyChart login page; after logging in, they would see their personalized My Action Plan Letter detailing their personalized, overdue preventive care measures.
  arm group label: Anecdote-based Reminder
  arm group label: Anecdote-based Reminder without link
  arm group label: Control Reminder
  arm group label: Research-based Reminder
  intervention type: Behavioral
  intervention name: Persuasion via anecdote
  description: The message will contain an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message prompts patients to click on a link to read the story about the patient.
  arm group label: Anecdote-based Reminder
  intervention type: Behavioral
  intervention name: Persuasion via anecdote without link
  description: The message will contain a link to an anecdote of a patient whose cancer was caught early through similar, recommended preventive screenings. The message won't contain a link to the story, but it will briefly describe the story.
  arm group label: Anecdote-based Reminder without link
  intervention type: Behavioral
  intervention name: Persuasion via research
  description: This message will mention that research has shown promptly closing health gaps saves lives.The message will contain a link to an official website that supports the statement.
  arm group label: Research-based Reminder
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Richard K. Leuchter, MD
  investigator title: Clinical Instructor of Medicine
  sharing ipd: No
  ipd description: We do not plan to make any individual participant data available.