<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/NCT04498052</url>
  </required_header>
  <id_info>
    <org_study_id>UUtah_00125797</org_study_id>
    <nct_id>NCT04498052</nct_id>
  </id_info>
  <brief_title>Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening</brief_title>
  <official_title>Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</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>
      The purpose of this project is to increase appropriate low-dose computed tomography (LDCT)&#xD;
      lung cancer screening through the development and wide dissemination of patient-centered&#xD;
      clinical decision support (CDS) tools that (1) are integrated with the electronic health&#xD;
      record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when&#xD;
      patients meet screening criteria, and (3) enable effective SDM using individually-tailored&#xD;
      information on the potential benefits and harms of screening. The study will promote standard&#xD;
      of care that is endorsed by the Centers for Medicare &amp; Medicaid Services (CMS) and the US&#xD;
      Preventive Services Task Force (USPSTF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this project is to increase appropriate low-dose computed tomography (LDCT)&#xD;
      lung cancer screening through the development and wide dissemination of patient-centered&#xD;
      clinical decision support (CDS) tools that (1) are integrated with the electronic health&#xD;
      record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when&#xD;
      patients meet screening criteria, and (3) enable effective SDM using individually-tailored&#xD;
      information on the potential benefits and harms of screening. The study will promote standard&#xD;
      of care that is endorsed by the Centers for Medicare &amp; Medicaid Services (CMS) and the US&#xD;
      Preventive Services Task Force (USPSTF). This project is supported both operationally and by&#xD;
      an Agency for Healthcare Research and Quality (AHRQ) R18 grant.&#xD;
&#xD;
      This project will leverage Decision Precision, a validated Web-based tool for LDCT SDM&#xD;
      developed at the Veterans Health Administration, as well as an initial version of Decision&#xD;
      Precision+, an EHR-integrated version of the tool which can be accessed directly in the EHR&#xD;
      and auto-populate relevant patient data in the tool instead of requiring manual data entry.&#xD;
&#xD;
      This study will be an 18-month interrupted time series study conducted at the University of&#xD;
      Utah Health primary care clinics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 23, 2020</start_date>
  <completion_date type="Anticipated">September 28, 2024</completion_date>
  <primary_completion_date type="Actual">September 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>interrupted time series</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking due to the nature of the intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in LDCT screening rate among eligible patients</measure>
    <time_frame>Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period</time_frame>
    <description>Change in proportion of patients eligible for LDCT screening per USPSTF guidelines receiving LDCT screening</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated number of lung cancer deaths prevented</measure>
    <time_frame>Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period</time_frame>
    <description>Estimated number of lung cancer deaths prevented given the risk profiles of individuals screened with LDCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated number of major complications</measure>
    <time_frame>Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period</time_frame>
    <description>Estimated number of major complications given the risk profiles of individuals screened with LDCT</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of use of the intervention</measure>
    <time_frame>Through study completion, an average of 18 months for the intervention period</time_frame>
    <description>The rate of usage of the intervention will be measured. The usage will be measured through system logs and data from the enterprise data warehouse. We will also seek to model patient, clinical user, and context predictors of tool usage.</description>
  </other_outcome>
  <other_outcome>
    <measure>Usability of the intervention as measured by System Usability Scale</measure>
    <time_frame>Through study completion, an average of 18 months for the intervention period</time_frame>
    <description>Usability of the intervention will be solicited during the study to support the implementation and make adjustments to the intervention as needed. Towards the end of the evaluation period, usability will be measured though the System Usability Scale survey.</description>
  </other_outcome>
  <other_outcome>
    <measure>Return on investment</measure>
    <time_frame>Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period</time_frame>
    <description>We will report whether investment in a program to promote appropriate screening for lung cancer can lead to a positive financial return on investment. If so, the number of years before such an investment can break even will be reported.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Early Detection of Cancer</condition>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients eligible for LDCT lung cancer screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to USPSTF guidelines, who are seen by a pilot user of the intervention. The inclusion criteria are (i) &gt;= 55 years and &lt;= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken.&#xD;
USPSTF guidelines may change during the study. In particular, it is anticipated that the guidelines may update during the study whereby the minimum age is reduced to 50 (from 55) and the minimum smoking history is reduced to 20 years (from 30). In the event that the USPSTF guidelines change, the intervention will be updated to match the change to the guidelines. We may also update the study evaluation to match the updated USPSTF guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening</intervention_name>
    <description>The intervention will consist of the following core items:&#xD;
An EHR-integrated shared decision making (SDM) tool for providing information on the risks and benefits of lung cancer screening through low-dose computed tomography (LDCT) testing. This intervention is referred to as Decision Precision+.&#xD;
Suggestions in the EHR to offer SDM for LDCT for patients eligible for lung cancer screening according to USPSTF guidelines. These suggestions include those provided by the EHR's &quot;Health Maintenance&quot; module as well as an EHR-integrated &quot;Disease Manager&quot; system for disease management and health maintenance.&#xD;
Improvements may also be introduced based on user feedback. All major enhancements will be introduced with the support and approval of the appropriate governance group.&#xD;
Following roll-out, clinic leaders may also receive periodic feedback on use of the intervention and LDCT screening rates, as well as advice on how to improve intervention adoption.</description>
    <arm_group_label>Patients eligible for LDCT lung cancer screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  receives care at University of Utah primary care clinics;&#xD;
&#xD;
          -  does not already have lung cancer;&#xD;
&#xD;
          -  meets USPSTF criteria for LDCT screening (currently, age &gt;= 55 years and &lt;= 80 years&#xD;
             old at the time of the visit; 30+ pack-year smoking history and current smoker or quit&#xD;
             in the past 15 years) or may meet the criteria if a complete smoking history were&#xD;
             taken.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kensaku Kawamoto, MD, PhD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah Health</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Tammemagi MC, Katki HA, Hocking WG, Church TR, Caporaso N, Kvale PA, Chaturvedi AK, Silvestri GA, Riley TL, Commins J, Berg CD. Selection criteria for lung-cancer screening. N Engl J Med. 2013 Feb 21;368(8):728-36. doi: 10.1056/NEJMoa1211776. Erratum In: N Engl J Med. 2013 Jul 25;369(4):394.</citation>
    <PMID>23425165</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Kensaku Kawamoto, MD, PhD, MHS</investigator_full_name>
    <investigator_title>Associate Chief Medical Information Officer</investigator_title>
  </responsible_party>
  <keyword>Lung Cancer Screening</keyword>
  <keyword>Clinical Decision Support</keyword>
  <keyword>Shared Decision Making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We are not planning to make individual participant data (IPD) available to other researchers.</ipd_description>
  </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/NCT04498052
org study id: UUtah_00125797
nct id: NCT04498052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to increase appropriate low-dose computed tomography (LDCT)
      lung cancer screening through the development and wide dissemination of patient-centered
      clinical decision support (CDS) tools that (1) are integrated with the electronic health
      record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when
      patients meet screening criteria, and (3) enable effective SDM using individually-tailored
      information on the potential benefits and harms of screening. The study will promote standard
      of care that is endorsed by the Centers for Medicare & Medicaid Services (CMS) and the US
      Preventive Services Task Force (USPSTF).
The purpose of this project is to increase appropriate low-dose computed tomography (LDCT)
      lung cancer screening through the development and wide dissemination of patient-centered
      clinical decision support (CDS) tools that (1) are integrated with the electronic health
      record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when
      patients meet screening criteria, and (3) enable effective SDM using individually-tailored
      information on the potential benefits and harms of screening. The study will promote standard
      of care that is endorsed by the Centers for Medicare & Medicaid Services (CMS) and the US
      Preventive Services Task Force (USPSTF). This project is supported both operationally and by
      an Agency for Healthcare Research and Quality (AHRQ) R18 grant.

      This project will leverage Decision Precision, a validated Web-based tool for LDCT SDM
      developed at the Veterans Health Administration, as well as an initial version of Decision
      Precision+, an EHR-integrated version of the tool which can be accessed directly in the EHR
      and auto-populate relevant patient data in the tool instead of requiring manual data entry.

      This study will be an 18-month interrupted time series study conducted at the University of
      Utah Health primary care clinics.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: interrupted time series
primary purpose: Screening
masking: None (Open Label)
masking description: no masking due to the nature of the intervention
measure: Change in LDCT screening rate among eligible patients
time frame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
description: Change in proportion of patients eligible for LDCT screening per USPSTF guidelines receiving LDCT screening
measure: Estimated number of lung cancer deaths prevented
time frame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
description: Estimated number of lung cancer deaths prevented given the risk profiles of individuals screened with LDCT
measure: Estimated number of major complications
time frame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
description: Estimated number of major complications given the risk profiles of individuals screened with LDCT
measure: Rate of use of the intervention
time frame: Through study completion, an average of 18 months for the intervention period
description: The rate of usage of the intervention will be measured. The usage will be measured through system logs and data from the enterprise data warehouse. We will also seek to model patient, clinical user, and context predictors of tool usage.
measure: Usability of the intervention as measured by System Usability Scale
time frame: Through study completion, an average of 18 months for the intervention period
description: Usability of the intervention will be solicited during the study to support the implementation and make adjustments to the intervention as needed. Towards the end of the evaluation period, usability will be measured though the System Usability Scale survey.
measure: Return on investment
time frame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
description: We will report whether investment in a program to promote appropriate screening for lung cancer can lead to a positive financial return on investment. If so, the number of years before such an investment can break even will be reported.
arm group label: Patients eligible for LDCT lung cancer screening
arm group type: Experimental
description: This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to USPSTF guidelines, who are seen by a pilot user of the intervention. The inclusion criteria are (i) >= 55 years and <= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken.
USPSTF guidelines may change during the study. In particular, it is anticipated that the guidelines may update during the study whereby the minimum age is reduced to 50 (from 55) and the minimum smoking history is reduced to 20 years (from 30). In the event that the USPSTF guidelines change, the intervention will be updated to match the change to the guidelines. We may also update the study evaluation to match the updated USPSTF guidelines.
intervention type: Other
intervention name: EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening
description: The intervention will consist of the following core items:
An EHR-integrated shared decision making (SDM) tool for providing information on the risks and benefits of lung cancer screening through low-dose computed tomography (LDCT) testing. This intervention is referred to as Decision Precision+.
Suggestions in the EHR to offer SDM for LDCT for patients eligible for lung cancer screening according to USPSTF guidelines. These suggestions include those provided by the EHR's "Health Maintenance" module as well as an EHR-integrated "Disease Manager" system for disease management and health maintenance.
Improvements may also be introduced based on user feedback. All major enhancements will be introduced with the support and approval of the appropriate governance group.
Following roll-out, clinic leaders may also receive periodic feedback on use of the intervention and LDCT screening rates, as well as advice on how to improve intervention adoption.
arm group label: Patients eligible for LDCT lung cancer screening
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kensaku Kawamoto, MD, PhD, MHS
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
citation: Tammemagi MC, Katki HA, Hocking WG, Church TR, Caporaso N, Kvale PA, Chaturvedi AK, Silvestri GA, Riley TL, Commins J, Berg CD. Selection criteria for lung-cancer screening. N Engl J Med. 2013 Feb 21;368(8):728-36. doi: 10.1056/NEJMoa1211776. Erratum In: N Engl J Med. 2013 Jul 25;369(4):394.
PMID: 23425165
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Kensaku Kawamoto, MD, PhD, MHS
investigator title: Associate Chief Medical Information Officer
mesh term: Lung Neoplasms
sharing ipd: No
ipd description: We are not planning to make individual participant data (IPD) available to other researchers.