NCT04498052

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

Completed NA Results posted Last updated 24 March 2025

What this trial tests

NA trial testing EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening in Early Detection of Cancer in 1,855 participants. Completed in 4 December 2024.

Timeline

23 August 2020

Primary endpoint
27 April 2022

4 December 2024

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	1,855
Start date	23 August 2020
Primary completion	27 April 2022
Estimated completion	4 December 2024
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Early Detection of Cancer — all drugs for Early Detection of Cancer →
• Lung Neoplasms — all drugs for Lung Neoplasms →

Sponsor

University of Utah

Who can join

Adults 55 to 80, any sex, with Early Detection of Cancer or Lung Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed Primary · 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 d

Group	Value	95% CI
Patients Eligible for LDCT Lung Cancer Screening	588

Number of Participants Who Used the Intervention Secondary · 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.

Group	Value	95% CI
Patients Eligible for LDCT Lung Cancer Screening	168

Sponsor's own 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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implementation of Lung Cancer Screening in Primary Care and Pulmonary Clinics: Pragmatic Clinical Trial of Electronic Health Record-Integrated Everyday Shared Decision-Making Tool and Clinician-Facing Prompts.
   Kukhareva PV, Li H, Caverly TJ, Del Fiol G, et al · · 2023 · cited 24× · PMID 37142092 · DOI 10.1016/j.chest.2023.04.040
2. Lung Cancer Screening Before and After a Multifaceted Electronic Health Record Intervention: A Nonrandomized Controlled Trial.
   Kukhareva PV, Li H, Caverly TJ, Fagerlin A, et al · · 2024 · cited 17× · PMID 38848065 · DOI 10.1001/jamanetworkopen.2024.15383