Skip to main content
OpenTrials
Completed

NCT Number: NCT04498052

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Early Detection of Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Health

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Exclusion criteria

  • None

Treatment and study plan

EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening

Other

The intervention will consist of the following core items:

In period 1:

  • 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.

In period 2:

  • Same as period 1 + simple patient reminders in the patient portal.

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.

Primary outcomes

  1. Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed

    Time frame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

    The LCS care gap was considered closed if one or more of the following events occurred: (1) LDCT completion in the past year, (2) completion of another chest CT in the past year, or (3) SDM documentation in the past 3 years for eligible patients. To assess population care-gap closure levels at the end of each study period, we estimated the care-gap closure status for all patients who had primary care visits in the 12 months preceding the last day of the period. Using structured EHR data, SDM was considered documented if a clinician noted the need for LCS discussion was addressed, the patient declined screening, or LCS was not appropriate.

Other outcomes

  1. Number of Participants Who Used the Intervention

    Time frame: Through study completion, an average of 18 months for the intervention period

    The number of participants who used the intervention was measured. The usage was measured through system logs and data from the enterprise data warehouse.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Aug 4, 2020
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.