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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04498052
• Other study ID #: UUtah_00125797
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2020
• Est. completion date: September 28, 2024

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12000
• Est. completion date: September 28, 2024
• Est. primary completion date: September 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Detection of Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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