<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/NCT02986230</url>
  </required_header>
  <id_info>
    <org_study_id>15-010</org_study_id>
    <nct_id>NCT02986230</nct_id>
  </id_info>
  <brief_title>Cancer Prevention Clinical Decision Support</brief_title>
  <acronym>CPW</acronym>
  <official_title>Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this project is to implement and evaluate the effectiveness of a&#xD;
      sophisticated Web-based, electronic health record (EHR)-linked clinical decision support&#xD;
      (CDS) system designed to improve primary and secondary cancer preventive care.&#xD;
&#xD;
      This project will engage a rural population with substantial healthcare disparities and gaps&#xD;
      in the receipt of primary and secondary cancer prevention. Results will advance dissemination&#xD;
      and implementation research methods that can reduce health disparities and improve healthcare&#xD;
      for millions in medically under-served areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this project is to implement and evaluate the effectiveness of a&#xD;
      sophisticated Web-based, electronic health record (EHR)-linked clinical decision support&#xD;
      (CDS) system designed to improve primary and secondary cancer preventive care. To achieve&#xD;
      this objective, a link from EHR data to evidence-based cancer prevention algorithms in a&#xD;
      secure Web site is created to: (a) identify at the point of care all eligible patients not up&#xD;
      to date on their cancer prevention interventions; and (b) present to both patient and primary&#xD;
      care provider (PCP) and/or a key member of the primary care team, certified medical assistant&#xD;
      (CMA), appropriate evidence-based primary cancer prevention interventions and cancer&#xD;
      screening options at the point of care. The Cancer Prevention-CDS will focus on breast cancer&#xD;
      screening in women aged 50-74, colorectal cancer screening for both sexes aged 50-75,&#xD;
      cervical cancer screening for women aged 21-65, human papilloma virus (HPV) vaccination for&#xD;
      both sexes aged 11-26, and referrals for weight management and smoking cessation in all&#xD;
      adults aged 18 and older. Effectiveness is assessed by cluster-randomizing 30 primary care&#xD;
      clinics with roughly 285 PCPs and 153,000 study-eligible patients into one of three&#xD;
      experimental conditions: Group 1: PCP-focused CDS intervention in which the PCP triggers use&#xD;
      of the CDS system and engages patients in appropriate cancer prevention strategies. Group 2:&#xD;
      SDMT-focused CDS intervention in which the CMA triggers use of the CDS system along with&#xD;
      additional shared decision making tools and interacts with the patient to engage them in&#xD;
      appropriate cancer prevention strategies before seeing their PCP, who will approve or discuss&#xD;
      the plan with their patient. Group 3: clinics provide usual care with no intervention-related&#xD;
      activity related to cancer prevention. With 10 clinics, 95 PCPs, and 51,000 potentially&#xD;
      eligible patients per study arm, this study will formally test the hypothesis that Groups 1&#xD;
      and 2 are superior to Group 3 over an 18-month follow-up period with respect to: (a)&#xD;
      significantly higher rates of appropriate screening for breast, cervix, and colorectal&#xD;
      cancer, as defined by the United States Preventive Services Task Force; and (b) significantly&#xD;
      higher rates of human papillomavirus (HPV) vaccination in males and females aged 11-26 years.&#xD;
      The investigators further posit that Groups 1 and 2 will have higher short-term health care&#xD;
      costs but better long-term cost-effectiveness than Group 3. The Consolidated Framework for&#xD;
      Implementation Research (CFIR) and RE-AIM conceptual frameworks will be used to guide&#xD;
      implementation planning, organization, conduct, and impact evaluation of the intervention in&#xD;
      a large rural healthcare system.&#xD;
&#xD;
      This project will engage a rural population with substantial healthcare disparities and gaps&#xD;
      in the receipt of primary and secondary cancer prevention. Results will advance dissemination&#xD;
      and implementation research methods that can reduce health disparities and improve healthcare&#xD;
      for millions in medically under-served areas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer screening tests</measure>
    <time_frame>within 18 months of index date</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30252</enrollment>
  <condition>Cancer Prevention</condition>
  <arm_group>
    <arm_group_label>PCP-focused group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SDMT-focused group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cancer prevention wizard (CPW)</intervention_name>
    <description>The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.</description>
    <arm_group_label>PCP-focused group</arm_group_label>
    <arm_group_label>SDMT-focused group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meet above age criteria&#xD;
&#xD;
          -  pcp practice at randomized clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current or past cancer diagnosis (excludes nonmelanoma skin cancer)&#xD;
&#xD;
          -  hospice care or cancer chemotherapy&#xD;
&#xD;
          -  Alzheimer's disease codes&#xD;
&#xD;
          -  major cardiovascular event in 12 months prior to index date&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas E Elliott, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HealthPartners Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heidi Ekstrom</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>April 9, 2021</last_update_submitted>
  <last_update_submitted_qc>April 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer prevention</keyword>
  <keyword>Clinical Decision Support</keyword>
  <keyword>Rural Health</keyword>
  <keyword>Shared Decision Making</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 9, 2022</submitted>
    <returned>April 14, 2022</returned>
    <submitted>May 5, 2022</submitted>
    <submission_canceled>May 17, 2022</submission_canceled>
    <submitted>June 6, 2022</submitted>
    <returned>March 15, 2023</returned>
    <submitted>April 7, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02986230
org study id: 15-010
nct id: NCT02986230
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this project is to implement and evaluate the effectiveness of a
      sophisticated Web-based, electronic health record (EHR)-linked clinical decision support
      (CDS) system designed to improve primary and secondary cancer preventive care.

      This project will engage a rural population with substantial healthcare disparities and gaps
      in the receipt of primary and secondary cancer prevention. Results will advance dissemination
      and implementation research methods that can reduce health disparities and improve healthcare
      for millions in medically under-served areas.
The objective of this project is to implement and evaluate the effectiveness of a
      sophisticated Web-based, electronic health record (EHR)-linked clinical decision support
      (CDS) system designed to improve primary and secondary cancer preventive care. To achieve
      this objective, a link from EHR data to evidence-based cancer prevention algorithms in a
      secure Web site is created to: (a) identify at the point of care all eligible patients not up
      to date on their cancer prevention interventions; and (b) present to both patient and primary
      care provider (PCP) and/or a key member of the primary care team, certified medical assistant
      (CMA), appropriate evidence-based primary cancer prevention interventions and cancer
      screening options at the point of care. The Cancer Prevention-CDS will focus on breast cancer
      screening in women aged 50-74, colorectal cancer screening for both sexes aged 50-75,
      cervical cancer screening for women aged 21-65, human papilloma virus (HPV) vaccination for
      both sexes aged 11-26, and referrals for weight management and smoking cessation in all
      adults aged 18 and older. Effectiveness is assessed by cluster-randomizing 30 primary care
      clinics with roughly 285 PCPs and 153,000 study-eligible patients into one of three
      experimental conditions: Group 1: PCP-focused CDS intervention in which the PCP triggers use
      of the CDS system and engages patients in appropriate cancer prevention strategies. Group 2:
      SDMT-focused CDS intervention in which the CMA triggers use of the CDS system along with
      additional shared decision making tools and interacts with the patient to engage them in
      appropriate cancer prevention strategies before seeing their PCP, who will approve or discuss
      the plan with their patient. Group 3: clinics provide usual care with no intervention-related
      activity related to cancer prevention. With 10 clinics, 95 PCPs, and 51,000 potentially
      eligible patients per study arm, this study will formally test the hypothesis that Groups 1
      and 2 are superior to Group 3 over an 18-month follow-up period with respect to: (a)
      significantly higher rates of appropriate screening for breast, cervix, and colorectal
      cancer, as defined by the United States Preventive Services Task Force; and (b) significantly
      higher rates of human papillomavirus (HPV) vaccination in males and females aged 11-26 years.
      The investigators further posit that Groups 1 and 2 will have higher short-term health care
      costs but better long-term cost-effectiveness than Group 3. The Consolidated Framework for
      Implementation Research (CFIR) and RE-AIM conceptual frameworks will be used to guide
      implementation planning, organization, conduct, and impact evaluation of the intervention in
      a large rural healthcare system.

      This project will engage a rural population with substantial healthcare disparities and gaps
      in the receipt of primary and secondary cancer prevention. Results will advance dissemination
      and implementation research methods that can reduce health disparities and improve healthcare
      for millions in medically under-served areas.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Cancer screening tests
time frame: within 18 months of index date
arm group label: PCP-focused group
arm group type: Experimental
description: The PCP-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
arm group label: SDMT-focused group
arm group type: Experimental
description: The SDMT-focused group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The SDMT-focused arm also provides shared decision making tools to patient and provider at the time of the visit.
intervention type: Other
intervention name: Cancer prevention wizard (CPW)
description: The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
arm group label: PCP-focused group
arm group label: SDMT-focused group
criteria: 
gender: All
minimum age: 11 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas E Elliott, MD
role: Principal Investigator
affiliation: HealthPartners Institute
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
submitted: February 9, 2022
returned: April 14, 2022
submitted: May 5, 2022
submission canceled: May 17, 2022
submitted: June 6, 2022
returned: March 15, 2023
submitted: April 7, 2023