<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/NCT04427527</url>
  </required_header>
  <id_info>
    <org_study_id>2018C0166</org_study_id>
    <secondary_id>UH3CA233282</secondary_id>
    <secondary_id>832127323</secondary_id>
    <nct_id>NCT04427527</nct_id>
  </id_info>
  <brief_title>Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia</brief_title>
  <acronym>ACCSIS</acronym>
  <official_title>Accelerating Colorectal Cancer Screening Through Implementation Science in Appalachia (ACCSIS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</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>
      This project aims to implement a multi-level group randomized trial, delayed intervention&#xD;
      that includes components targeting clinics, providers, patients, and the community to&#xD;
      increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients&#xD;
      age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned&#xD;
      to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening)&#xD;
      will be obtained from clinic-level electronic health record data and a county-level&#xD;
      behavioral assessment telephone survey. The hypothesis for the project is that the&#xD;
      multi-level intervention will increase the clinic and county level CRC screening rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Factorial Assignment</intervention_model>
    <intervention_model_description>Primary care clinics randomized to intervention or usual care</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Primary care clinics randomized to usual care do not receive intervention materials or attention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CRC screening - clinic level</measure>
    <time_frame>12 months</time_frame>
    <description>Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CRC screening - community level</measure>
    <time_frame>12 months</time_frame>
    <description>Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">6240</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Multi-level Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives the project intervention first</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Multi-level Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Offered the intervention later in the project</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multi-level intervention to increase CRC screening</intervention_name>
    <description>Intervention for the community, providers, patients, clinics and systems</description>
    <arm_group_label>Multi-level Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 50-74&#xD;
&#xD;
          -  all races, sexes and genders&#xD;
&#xD;
          -  resident of the study area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        .no exclusions based on gender, race or ethnicity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-report of gender</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark B Dignan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mark B Dignan, PhD</last_name>
    <phone>859-323-4708</phone>
    <email>mark.dignan@uky.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Cromo, BS</last_name>
    <phone>859-257-3833</phone>
    <email>mark.cromo@uky.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Dignan, Ph.D., MPH</last_name>
      <phone>859-323-4708</phone>
      <email>mbdign2@email.uky.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mark Cromo, BS</last_name>
      <phone>859-257-3833</phone>
      <email>mark.cromo@uky.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Electra Paskett, PhD</last_name>
      <phone>614-293-3917</phone>
      <email>electra.paskett@osumc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jill Oliveri, DrPH</last_name>
      <phone>614-293-8174</phone>
      <email>jill.oliveri@osumc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Mark Dignan, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Yes</sharing_ipd>
    <ipd_description>As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium.&#xD;
Dataset Items in the LDS are defined by the Common Data Elements.&#xD;
There also will be a &quot;public use data set&quot; that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers.&#xD;
In addition, all data that underlie results in publications will be available per Notice of Award.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Baseline data available beginning 10/2020, follow-up data available 12/2023</ipd_time_frame>
    <ipd_access_criteria>There are 2 classes of dataset requests: 1) public use and 2) special. Requestors submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use data set containing common data elements will be made available to external researchers by application. IMS responds to public use dataset application by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must first submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive review by NCI and Research Triangle Institute (RTI) before being forwarded to the SC for review and approval. Requestors report every 6 months on published articles or conference presentations to RTI. Requestors also are encouraged to make articles available through PubMed Central website.</ipd_access_criteria>
  </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/NCT04427527
org study id: 2018C0166
secondary id: UH3CA233282
secondary id: 832127323
nct id: NCT04427527
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to implement a multi-level group randomized trial, delayed intervention
      that includes components targeting clinics, providers, patients, and the community to
      increase colorectal cancer (CRC) screening, follow-up, and referral-to-care among patients
      age 50-74 in 12 counties in Appalachian Kentucky and Ohio. The 12 counties will be assigned
      to one of two study groups (early vs. delayed) and outcome measures (rate of CRC screening)
      will be obtained from clinic-level electronic health record data and a county-level
      behavioral assessment telephone survey. The hypothesis for the project is that the
      multi-level intervention will increase the clinic and county level CRC screening rates.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Primary care clinics randomized to intervention or usual care
primary purpose: Screening
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Primary care clinics randomized to usual care do not receive intervention materials or attention
measure: CRC screening - clinic level
time frame: 12 months
description: Change in clinic-level screening rate from baseline to the end of the 12-month active intervention period, assessed through clinic electronic health record data
measure: CRC screening - community level
time frame: 12 months
description: Self-reported participation in CRC screening from baseline to the end of the 12-month active intervention period, assessed through telephone surveys
arm group label: Multi-level Intervention
arm group type: Experimental
description: Receives the project intervention first
arm group label: Delayed Multi-level Intervention
arm group type: No Intervention
description: Offered the intervention later in the project
intervention type: Behavioral
intervention name: Multi-level intervention to increase CRC screening
description: Intervention for the community, providers, patients, clinics and systems
arm group label: Multi-level Intervention
criteria: 
gender: All
gender based: Yes
gender description: Self-report of gender
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark B Dignan, PhD
role: Principal Investigator
affiliation: University of Kentucky
last name: Mark B Dignan, PhD
phone: 859-323-4708
email: mark.dignan@uky.edu
last name: Mark Cromo, BS
phone: 859-257-3833
email: mark.cromo@uky.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kentucky
investigator full name: Mark Dignan, PhD
investigator title: Professor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: As outlined in the Notice of Award, each study site must make its Limited Data Set (LDS) accessible to other sites in the ACCSIS consortium. Information Management Services (IMS) will serve as the repository and have responsibility for creating a Limited Consolidated Data Set (LCDS) for analytic use of researchers both within and external to the ACCSIS consortium.
Dataset Items in the LDS are defined by the Common Data Elements.
There also will be a "public use data set" that consists of the Common Data Elements, available to external researchers. IMS will use a systematic process to remove identifiers.
In addition, all data that underlie results in publications will be available per Notice of Award.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Baseline data available beginning 10/2020, follow-up data available 12/2023
ipd access criteria: There are 2 classes of dataset requests: 1) public use and 2) special. Requestors submit necessary forms, including an agreement to acknowledge ACCSIS in publications and presentations. A public use data set containing common data elements will be made available to external researchers by application. IMS responds to public use dataset application by sending the requestor one-time access to a data download link. External researchers may also request a more customized data set. Requestors must first submit a brief concept form or ancillary studies form, for preliminary review by the ACCSIS Steering Committee (SC), before invitation to submit a full proposal. Full proposals receive review by NCI and Research Triangle Institute (RTI) before being forwarded to the SC for review and approval. Requestors report every 6 months on published articles or conference presentations to RTI. Requestors also are encouraged to make articles available through PubMed Central website.