search
Back to results

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

Primary Purpose

Early Detection of Cancer, Lung Neoplasms

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Early Detection of Cancer focused on measuring Lung Cancer Screening, Clinical Decision Support, Shared Decision Making

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients eligible for LDCT lung cancer screening

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in LDCT screening rate among eligible patients
Change in proportion of patients eligible for LDCT screening per USPSTF guidelines receiving LDCT screening

Secondary Outcome Measures

Estimated number of lung cancer deaths prevented
Estimated number of lung cancer deaths prevented given the risk profiles of individuals screened with LDCT
Estimated number of major complications
Estimated number of major complications given the risk profiles of individuals screened with LDCT

Full Information

First Posted
July 17, 2020
Last Updated
July 25, 2023
Sponsor
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT04498052
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2020 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Detection of Cancer, Lung Neoplasms
Keywords
Lung Cancer Screening, Clinical Decision Support, Shared Decision Making

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
interrupted time series
Masking
None (Open Label)
Masking Description
no masking due to the nature of the intervention
Allocation
N/A
Enrollment
12000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients eligible for LDCT lung cancer screening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in LDCT screening rate among eligible patients
Description
Change in proportion of patients eligible for LDCT screening per USPSTF guidelines receiving LDCT screening
Time Frame
Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
Secondary Outcome Measure Information:
Title
Estimated number of lung cancer deaths prevented
Description
Estimated number of lung cancer deaths prevented given the risk profiles of individuals screened with LDCT
Time Frame
Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
Title
Estimated number of major complications
Description
Estimated number of major complications given the risk profiles of individuals screened with LDCT
Time Frame
Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
Other Pre-specified Outcome Measures:
Title
Rate of use of the intervention
Description
The rate of usage of the intervention will be measured. The usage will be measured through system logs and data from the enterprise data warehouse. We will also seek to model patient, clinical user, and context predictors of tool usage.
Time Frame
Through study completion, an average of 18 months for the intervention period
Title
Usability of the intervention as measured by System Usability Scale
Description
Usability of the intervention will be solicited during the study to support the implementation and make adjustments to the intervention as needed. Towards the end of the evaluation period, usability will be measured though the System Usability Scale survey.
Time Frame
Through study completion, an average of 18 months for the intervention period
Title
Return on investment
Description
We will report whether investment in a program to promote appropriate screening for lung cancer can lead to a positive financial return on investment. If so, the number of years before such an investment can break even will be reported.
Time Frame
Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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) or may meet the criteria if a complete smoking history were taken. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kensaku Kawamoto, MD, PhD, MHS
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning to make individual participant data (IPD) available to other researchers.
Citations:
PubMed Identifier
23425165
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. Erratum In: N Engl J Med. 2013 Jul 25;369(4):394.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs