CClinicalTrials.gg
RecruitingNCT07682610Updated Jul 6, 2026

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

An interventional study of Quality Implementation of Lung Cancer Screening (QUILS) System in Lung Cancer Screening, sponsored by Timothy Mullett. Recruiting at 17 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Timothy Mullett · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2025, registered Jun 2026).
  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
35,500
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lung Cancer Screening
03

In context

Lead sponsor

Timothy Mullett is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35,500 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralQuality 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.

06

What researchers measure

Primary outcomes

  1. Change in Quality Improvement Lung Cancer Screening (QUILS) Index Assessment Score

    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.

    Time frame: Baseline and Month 9

07

Study locations

17 of 17 sites recruiting
  • King's Daughter's Medical Center
    Ashland, Kentucky 41101, United States
    Recruiting
  • Taylor Regional Hospital
    Campbellsville, Kentucky 42718, United States
    Recruiting
  • St. Elizabeth Healthcare
    Edgewood, Kentucky 41017, United States
    Recruiting
  • Georgetown Cancer Treatment Cancer
    Georgetown, Kentucky 40324, United States
    Recruiting
  • TJ Samson Community Hospital
    Glasgow, Kentucky 42141, United States
    Recruiting
  • Hazard Appalachian Regional Healthcare Medical Center
    Hazard, Kentucky 41701, United States
    Recruiting
  • Lexington VA Health Care System
    Lexington, Kentucky 40502, United States
    Recruiting
  • St. Joseph Health (Catholic Health Initiatives)
    Lexington, Kentucky 40504, United States
    Recruiting
  • University of Kentucky Markey Cancer Center
    Lexington, Kentucky 40506, United States
    Recruiting
  • The James Graham Brown Cancer Center at University of Louisville
    Louisville, Kentucky 40202, United States
    Recruiting
  • Meadowview Regional Medical Center
    Maysville, Kentucky 41056, United States
    Recruiting
  • Saint Claire Regional Medical Center
    Morehead, Kentucky 40351, United States
    Recruiting
  • Rockcastle Regional Hospital
    Mount Vernon, Kentucky 40456, United States
    Recruiting
  • Owensboro Health Mitchell Memorial Cancer Center
    Owensboro, Kentucky 42303, United States
    Recruiting
  • Mercy Health - Paducah Cancer Center
    Paducah, Kentucky 42003, United States
    Recruiting
  • Lake Cumberland Regional Hospital
    Somerset, Kentucky 42501, United States
    Recruiting
  • Clark Regional Medical Center
    Winchester, Kentucky 40391, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07682610
Lead sponsor
Timothy Mullett
Responsible party
Timothy Mullett (Professor, University of Kentucky) — Sponsor-investigator
First posted
Jul 6, 2026
Start date
Apr 1, 2025
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Jul 6, 2026

Study contacts

Joseph Alexander, MD
Contact
joseph.alexander@uky.edu
8593230892

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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