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

Study Overview
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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.

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

Conditions
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Early Detection of Cancer, Lung Neoplasms

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


Participation Criteria
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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) or may meet the criteria if a complete smoking history were taken. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: interrupted time series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients eligible for LDCT lung cancer screening<br>This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to USPSTF guidelines, who are seen by a pilot user of the intervention. 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. USPSTF guidelines may change during the study. In particular, it is anticipated that the guidelines may update during the study whereby the minimum age is reduced to 50 (from 55) and the minimum smoking history is reduced to 20 years (from 30). In the event that the USPSTF guidelines change, the intervention will be updated to match the change to the guidelines. We may also update the study evaluation to match the updated USPSTF guidelines. | Other: EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening<br>* The intervention will consist of the following core items: 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. Improvements may also be introduced based on user feedback. All major enhancements will be introduced with the support and approval of the appropriate governance group. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDCT screening rate among eligible patients | Change in proportion of patients eligible for LDCT screening per USPSTF guidelines receiving LDCT screening | Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated number of lung cancer deaths prevented | Estimated number of lung cancer deaths prevented given the risk profiles of individuals screened with LDCT | Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period | 
| Estimated number of major complications | Estimated number of major complications given the risk profiles of individuals screened with LDCT | Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer Screening, Clinical Decision Support, Shared Decision Making