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

NCT ID: NCT04498052

Last Updated: 2025-03-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1855 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-23

Study Completion Date

2024-12-04

Brief Summary

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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

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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.

Conditions

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Early Detection of Cancer Lung Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

interrupted time series
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

no masking due to the nature of the intervention

Study Groups

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Patients eligible for LDCT lung cancer screening

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Kensaku Kawamoto, MD, PhD, MHS

Associate Chief Medical Information Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kensaku Kawamoto, MD, PhD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah Health

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23425165 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38848065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37142092 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UUtah_00125797

Identifier Type: -

Identifier Source: org_study_id

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