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

NCT04498052 | Completed Results

• 1 other identifier: UUtah_00125797
• Study Type: interventional
• Target: 1,855
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Early Detection of Cancer; Lung Neoplasms

Keywords

Lung Cancer Screening; Clinical Decision Support; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Other Outcomes (1)

• Number of Participants Who Used the Intervention

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

Study Arms (1)

Patients eligible for LDCT lung cancer screening

EXPERIMENTAL

This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to 2013 USPSTF guidelines. 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.

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

Interventions

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.

Patients eligible for LDCT lung cancer screening

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

• 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.

  PMID: 23425165 BACKGROUND

• Kukhareva PV, Li H, Caverly TJ, Fagerlin A, Del Fiol G, Hess R, Zhang Y, Butler JM, Schlechter C, Flynn MC, Reddy C, Choi J, Balbin C, Warner IA, Warner PB, Nanjo C, Kawamoto K. Lung Cancer Screening Before and After a Multifaceted Electronic Health Record Intervention: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415383. doi: 10.1001/jamanetworkopen.2024.15383.

  PMID: 38848065 DERIVED

• Kukhareva PV, Li H, Caverly TJ, Del Fiol G, Fagerlin A, Butler JM, Hess R, Zhang Y, Taft T, Flynn MC, Reddy C, Martin DK, Warner IA, Rodriguez-Loya S, Warner PB, Kawamoto K. 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. Chest. 2023 Nov;164(5):1325-1338. doi: 10.1016/j.chest.2023.04.040. Epub 2023 May 3.

  PMID: 37142092 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Kensaku Kawamoto, MD, PhD, MHS / Associate Chief Medical Information Officer
• Organization: University of Utah

kensaku.kawamoto@utah.edu

801-581-4080

Study Officials

• Kensaku Kawamoto, MD, PhD, MHS

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking due to the nature of the intervention
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Medical Information Officer

Model Details: interrupted time series

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 4, 2020
• Study Start: August 23, 2020
• Primary Completion: April 27, 2022
• Study Completion: December 4, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)