Clinical trial NCT04498052: Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening
Official title: Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Detection of Cancer
Lung Neoplasms
Keywords: Lung Cancer Screening
Clinical Decision Support
Shared Decision Making
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 1855
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interrupted time series
Primary purpose: SCREENING

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed
timeFrame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
Secondary outcomes:
Other outcomes:
measure: Number of Participants Who Used the Intervention
timeFrame: Through study completion, an average of 18 months for the intervention period
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Kensaku Kawamoto, MD, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.