Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Neoplasms; Early Detection of Cancer
• Intervention / Treatment: Other: EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 12000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• receives care at University of Utah primary care clinics;
• does not already have lung cancer;
• meets USPSTF criteria for LDCT screening (currently, age >= 55 years and <= 80 years old at the time of the visit; 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.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients eligible for LDCT lung cancer screening; 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.

Other: EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDCT screening rate among eligible patients	Change in proportion of patients eligible for LDCT screening per USPSTF guidelines receiving LDCT screening	Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated number of lung cancer deaths prevented	Estimated number of lung cancer deaths prevented given the risk profiles of individuals screened with LDCT	Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
Estimated number of major complications	Estimated number of major complications given the risk profiles of individuals screened with LDCT	Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of use of the intervention	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.	Through study completion, an average of 18 months for the intervention period
Usability of the intervention as measured by System Usability Scale	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.	Through study completion, an average of 18 months for the intervention period
Return on investment	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.	Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Kensaku Kawamoto, MD, PhD, MHS, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2020
• Primary Completion (Actual): September 28, 2022
• Study Completion (Estimated): September 28, 2024

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Shared Decision Making; Lung Cancer Screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: UUtah_00125797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No