Kentucky - Quality Improvement Implementation Lung Cancer Screening (QUILS™) Health Services Research Intervention

June 26, 2026 updated by: Timothy Mullett

Statewide Optimization of Lung Cancer Screening Utilizing the QUILS™ System (Kentucky QUILS™ Implementation): HSR Intervention

This clinical trial studies statewide optimization of lung cancer screening (LCS) in Kentucky using the Quality Implementation of Lung Screening (QUILS™) System. Data from the Kentucky Cancer Registry shows that LCS implementation has contributed to a rapid decline in late-stage lung cancer diagnosis at twice the national average. Further, the declines are more than three times the national average decline in Kentucky's Central Appalachian region. Kentucky-based multilevel initiatives are needed to expand and accelerate this leading role and extend the LCS opportunity to more Kentuckians who are at increased risk of lung cancer. This trial may be able to accelerate optimal high-quality implementation of LCS utilizing the QUILS™ System and reduce the burden of lung cancer by assisting lung cancer screening programs located throughout Kentucky in implementing best practices in lung cancer screening by integrating the QUILS™ System domains and elements into their screening programs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Recruiting
        • King's Daughter's Medical Center
        • Contact:
      • Campbellsville, Kentucky, United States, 42718
        • Recruiting
        • Taylor Regional Hospital
        • Contact:
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • St. Elizabeth Healthcare
        • Contact:
      • Georgetown, Kentucky, United States, 40324
        • Recruiting
        • Georgetown Cancer Treatment Cancer
        • Contact:
      • Glasgow, Kentucky, United States, 42141
        • Recruiting
        • TJ Samson Community Hospital
        • Contact:
      • Hazard, Kentucky, United States, 41701
        • Recruiting
        • Hazard Appalachian Regional Healthcare Medical Center
        • Contact:
      • Lexington, Kentucky, United States, 40502
        • Recruiting
        • Lexington VA Health Care System
        • Contact:
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • St. Joseph Health (Catholic Health Initiatives)
        • Contact:
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Markey Cancer Center
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
      • Maysville, Kentucky, United States, 41056
        • Recruiting
        • Meadowview Regional Medical Center
        • Contact:
      • Morehead, Kentucky, United States, 40351
        • Recruiting
        • Saint Claire Regional Medical Center
        • Contact:
      • Mount Vernon, Kentucky, United States, 40456
        • Recruiting
        • Rockcastle Regional Hospital
        • Contact:
      • Owensboro, Kentucky, United States, 42303
        • Recruiting
        • Owensboro Health Mitchell Memorial Cancer Center
        • Contact:
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • Mercy Health - Paducah Cancer Center
        • Contact:
      • Somerset, Kentucky, United States, 42501
        • Recruiting
        • Lake Cumberland Regional Hospital
        • Contact:
      • Winchester, Kentucky, United States, 40391
        • Recruiting
        • Clark Regional Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Member of a participating Lung Cancer Screening Program (LCSP) team or administrator
  • Willing to participate in the QUILS Index Assessment Survey process
  • Willing to participate in the QUILS Audit Feedback presentations
  • Willing to participate in formative evaluation interviews

Exclusion Criteria:

  • Unwilling to participate in the QUILS Index Assessment Survey process
  • Unwilling to participate in the QUILS Audit Feedback presentations
  • Unwilling to participate in formative evaluation interviews

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QUILS System Implementation
Participants who are members of the lung cancer screening program (LCSP) team will receive the QUILS System intervention, including completion of the QUILS Index Assessment, participation in QUILS Audit and Feedback presentations, access tot the QUILS Resource Portal and site specific action plans, and formative evaluation interviews.
Behavioral: Quality Implementation of Lung Cancer Screening (QUILS) System
The QUILS System is a health services research intervention designed to improve the quality of lung cancer screening programs. The intervention includes QUILS Index Assessment, QUILS Audit and Feedback Report and Presentation, QUILS Resource Portal, site-specific action plans, and formative evaluation activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality Improvement Lung Cancer Screening (QUILS) Index Assessment Score
Time Frame: Baseline and Month 9
The QUILS Index Assessment is a program-level measure of lung cancer screening implementation quality. Scores range from 0 to 95, with a higher score indicating higher quality implementation of lung cancer screening practices. The outcome measure is the change in total QUILS Index score from Baseline to 12 months.
Baseline and Month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy Mullett

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-25-KQUILS-PT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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