<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/NCT03275987</url>
  </required_header>
  <id_info>
    <org_study_id>Innovations2017</org_study_id>
    <nct_id>NCT03275987</nct_id>
  </id_info>
  <brief_title>Promoting Cancer Screening Among Medicaid Recipients in Minnesota</brief_title>
  <official_title>A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minnesota Department of Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minnesota Department of Health</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 study evaluates the effectiveness of persuasive direct mail materials coupled with an&#xD;
      incentive for increasing breast and colorectal cancer screening among people enrolled in&#xD;
      Medicaid. Half of age- and gender-appropriate enrollees received this intervention; the other&#xD;
      half received the same intervention 15 months later&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial was conducted between April 2014 and July 2015 and implemented through Sage, the&#xD;
      National Breast and Cervical Cancer Early Detection Program (NBCCEDP) in Minnesota and housed&#xD;
      within the Minnesota Department of Health (MDH). The target population was all Minnesota&#xD;
      Medicaid recipients ages 50-74 overdue for breast cancer and colorectal cancer screening.&#xD;
      Claims data, obtained from MDHS, were used to determine patient characteristics and outcomes.&#xD;
      Individuals who were not enrolled in Medicaid, who were not overdue for BC or CRC screening,&#xD;
      or who were not in the 50-74 age range were excluded prior to analysis.&#xD;
&#xD;
      To determine the efficacy of the interventions we used a two group posttest-only randomized&#xD;
      design with all eligible MA beneficiaries randomly assigned to one of two groups: Direct Mail&#xD;
      plus Incentive (with patient navigation) versus usual care.&#xD;
&#xD;
      The primary outcomes were completion of mammography or colonoscopy within 12 weeks after&#xD;
      implementation of the intervention. Current Procedural Technology (CPT) codes from Medicaid&#xD;
      claims data were used to determine if an individual had received either mammography or&#xD;
      colonoscopy. Specific CPT codes used for mammography were conventional mammography&#xD;
      (77055-77057), digital mammography (G0202, G0204, G0206), and computer-aided detection&#xD;
      mammography (77051, 77052). CPT codes used for colonoscopy were G0105, G0121, 45378, and&#xD;
      45380-45385. Mammography and colonoscopy outcomes were measured dichotomously. Outcomes were&#xD;
      based on the presence of screening mammography and colonoscopy claims occurring for 10 weeks&#xD;
      after the first mailings.&#xD;
&#xD;
      The mammography and colonoscopy interventions were examined separately. Across treatment and&#xD;
      control, study sample characteristics were compared and absolute differences were assessed&#xD;
      using t-test and χ2 statistics. Main outcome analyses consisted of logistic regression to&#xD;
      compute odds ratios for receiving mammography or colonoscopy and for covariate adjustment.&#xD;
      Two separate logistic regression models were examined for both mammography and colonoscopy&#xD;
      interventions: (1) a bivariate model that examined treatment versus control, and 2) a&#xD;
      multivariate model that adjusted for covariates. All analyses were conducted using Stata,&#xD;
      version 13.&#xD;
&#xD;
      Some individuals lost Medicaid coverage on a monthly basis during the study period, and&#xD;
      others had inaccurate mailing addresses (&lt; 2% of each study sample). Therefore not everyone&#xD;
      received the treatment as intended, and individuals that received the intervention may not&#xD;
      have had Medicaid claims available post-intervention. Our outcome analyses were&#xD;
      intent-to-treat analyses that included all individuals randomized to treatment or control&#xD;
      groups at initiation of intervention regardless of whether they lost coverage&#xD;
      post-randomization or if they had an inaccurate mailing address.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2014</start_date>
  <completion_date type="Actual">May 10, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>screening mammography or colonoscopy</measure>
    <time_frame>Within 12 weeks of first mailing</time_frame>
    <description>Evidence of a mammogram received after implementation of the intervention, based on presence of CPT codes in Medicaid claims data set.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">138554</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Mammography treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mammography direct mail coupled with a financial incentive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mammography control/delayed intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colonoscopy treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Colonoscopy direct mail coupled with a financial incentive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colonoscopy control/delayed intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mammography direct mail coupled with a financial incentive</intervention_name>
    <description>The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.</description>
    <arm_group_label>Mammography control/delayed intervention</arm_group_label>
    <arm_group_label>Mammography treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Group received usual care, and direct mail 15 months after treatment group received intervention.</description>
    <arm_group_label>Colonoscopy control/delayed intervention</arm_group_label>
    <arm_group_label>Mammography control/delayed intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Colonoscopy direct mail coupled with a financial incentive</intervention_name>
    <description>The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.</description>
    <arm_group_label>Colonoscopy control/delayed intervention</arm_group_label>
    <arm_group_label>Colonoscopy treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Minnesota Medicaid for at least the prior year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 50 or older than 74&#xD;
&#xD;
          -  Women having mammogram in 15 months before trial (mammography intervention)&#xD;
&#xD;
          -  Evidence of a colonoscopy in the past 10 years, flexible sigmoidoscopy in the past&#xD;
             five years, or fecal immunochemical or fecal occult blood test in the past year&#xD;
             (colonoscopy intervention)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Mammography arm was limited to women. Colonoscopy arm included both genders.</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan S Slater, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minnesota Department of Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christina L Nelson, MS</last_name>
    <role>Study Director</role>
    <affiliation>Minnesota Department of Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minnesota Department of Health</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55164</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minnesota Department of Health</investigator_affiliation>
    <investigator_full_name>Jonathan Slater</investigator_full_name>
    <investigator_title>Chief of Cancer Control Section</investigator_title>
  </responsible_party>
  <keyword>cancer screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03275987
org study id: Innovations2017
nct id: NCT03275987
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness of persuasive direct mail materials coupled with an
      incentive for increasing breast and colorectal cancer screening among people enrolled in
      Medicaid. Half of age- and gender-appropriate enrollees received this intervention; the other
      half received the same intervention 15 months later
This trial was conducted between April 2014 and July 2015 and implemented through Sage, the
      National Breast and Cervical Cancer Early Detection Program (NBCCEDP) in Minnesota and housed
      within the Minnesota Department of Health (MDH). The target population was all Minnesota
      Medicaid recipients ages 50-74 overdue for breast cancer and colorectal cancer screening.
      Claims data, obtained from MDHS, were used to determine patient characteristics and outcomes.
      Individuals who were not enrolled in Medicaid, who were not overdue for BC or CRC screening,
      or who were not in the 50-74 age range were excluded prior to analysis.

      To determine the efficacy of the interventions we used a two group posttest-only randomized
      design with all eligible MA beneficiaries randomly assigned to one of two groups: Direct Mail
      plus Incentive (with patient navigation) versus usual care.

      The primary outcomes were completion of mammography or colonoscopy within 12 weeks after
      implementation of the intervention. Current Procedural Technology (CPT) codes from Medicaid
      claims data were used to determine if an individual had received either mammography or
      colonoscopy. Specific CPT codes used for mammography were conventional mammography
      (77055-77057), digital mammography (G0202, G0204, G0206), and computer-aided detection
      mammography (77051, 77052). CPT codes used for colonoscopy were G0105, G0121, 45378, and
      45380-45385. Mammography and colonoscopy outcomes were measured dichotomously. Outcomes were
      based on the presence of screening mammography and colonoscopy claims occurring for 10 weeks
      after the first mailings.

      The mammography and colonoscopy interventions were examined separately. Across treatment and
      control, study sample characteristics were compared and absolute differences were assessed
      using t-test and χ2 statistics. Main outcome analyses consisted of logistic regression to
      compute odds ratios for receiving mammography or colonoscopy and for covariate adjustment.
      Two separate logistic regression models were examined for both mammography and colonoscopy
      interventions: (1) a bivariate model that examined treatment versus control, and 2) a
      multivariate model that adjusted for covariates. All analyses were conducted using Stata,
      version 13.

      Some individuals lost Medicaid coverage on a monthly basis during the study period, and
      others had inaccurate mailing addresses (< 2% of each study sample). Therefore not everyone
      received the treatment as intended, and individuals that received the intervention may not
      have had Medicaid claims available post-intervention. Our outcome analyses were
      intent-to-treat analyses that included all individuals randomized to treatment or control
      groups at initiation of intervention regardless of whether they lost coverage
      post-randomization or if they had an inaccurate mailing address.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
measure: screening mammography or colonoscopy
time frame: Within 12 weeks of first mailing
description: Evidence of a mammogram received after implementation of the intervention, based on presence of CPT codes in Medicaid claims data set.
arm group label: Mammography treatment
arm group type: Experimental
description: Mammography direct mail coupled with a financial incentive
arm group label: Mammography control/delayed intervention
arm group type: Active Comparator
description: Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)
arm group label: Colonoscopy treatment
arm group type: Experimental
description: Colonoscopy direct mail coupled with a financial incentive
arm group label: Colonoscopy control/delayed intervention
arm group type: Active Comparator
description: Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)
intervention type: Behavioral
intervention name: Mammography direct mail coupled with a financial incentive
description: The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
arm group label: Mammography control/delayed intervention
arm group label: Mammography treatment
intervention type: Behavioral
intervention name: Usual care
description: Group received usual care, and direct mail 15 months after treatment group received intervention.
arm group label: Colonoscopy control/delayed intervention
arm group label: Mammography control/delayed intervention
intervention type: Behavioral
intervention name: Colonoscopy direct mail coupled with a financial incentive
description: The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
arm group label: Colonoscopy control/delayed intervention
arm group label: Colonoscopy treatment
criteria: 
gender: All
gender based: Yes
gender description: Mammography arm was limited to women. Colonoscopy arm included both genders.
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: No
last name: Jonathan S Slater, PhD
role: Principal Investigator
affiliation: Minnesota Department of Health
last name: Christina L Nelson, MS
role: Study Director
affiliation: Minnesota Department of Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Minnesota Department of Health
investigator full name: Jonathan Slater
investigator title: Chief of Cancer Control Section
mesh term: Colorectal Neoplasms
sharing ipd: No