- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06474611
Evaluation of a Patient 'nudge' on Engagement in Lung Cancer Screening
February 21, 2025 updated by: Debra Ritzwoller, Kaiser Permanente
The purpose of this quality improvement project is to conduct and evaluate the effect of sending an electronic reminder message to patients who qualify for lung cancer screening, haven't had a screening previously, and who have an upcoming scheduled appointment with their doctor.
Study Overview
Detailed Description
United States Preventive Services Task Force (USPSTF) lung cancer screening (LCS) guidelines recommend LCS for those aged 50-80 with at least 20 pack-years smoking history, who currently smoke or quit within the last 15 years.
In 2023, our study team found that there are approximately 6,000 - 8,000 Kaiser Permanente Colorado (KPCO) members who are unscreened and eligible for lung cancer screening (LCS).
In support of KP's Population Health priority initiative to expand lung cancer screening participation for those who are eligible, our study team was selected to move this work forward in 2024 with feasible implementation opportunities for the KPCO LCS Operational/Institute for Health Research partnership at its core.
The primary objective of this project is to conduct and evaluate a randomized quality improvement pragmatic intervention of a 2-arm electronic message outreach to unscreened LCS members who are eligible for LCS and who have an upcoming scheduled Primary Care Provider (PCP) visit.
Study Type
Interventional
Enrollment (Actual)
894
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 Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80011
- Kaiser Permanente
-
-
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
No
Description
Inclusion Criteria: Qualifies for Lung Cancer Screening based on USPSTF criteria (aged 50-80, at least 20 pack years smoking history, currently smoke or quit in the last 15 years); have an upcoming, scheduled Primary Care visit in a KP clinic in the coming 7-14 days, have not completed a low-dose CT scan.
Exclusion Criteria:
- None
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Birth year = odd
No intervention, care as usual
|
|
|
Experimental: Birth year = even AND active on KP.org
Has an upcoming primary care visit, qualifies for lung cancer screening based on USPSTF criteria, receives an electronic letter via KP.org informing that they qualify for LCS and reminding to talk to PCP about LCS at next visit.
|
Patient receives an electronic or paper letter 'nudge' to talk to dr about LCS.
|
|
Experimental: Birth year = even AND not active on KP.org
Has an upcoming primary care visit, qualifies for LCS based on USPSTF criteria, receives a mailed letter informing that they qualify for LCS and reminding to talk to provider about LCS at next visit.
|
Patient receives an electronic or paper letter 'nudge' to talk to dr about LCS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion completed a visit with a Primary Care provider by receipt of an electronic letter or paper letter
Time Frame: 12 months
|
The proportion completed a visit with a Primary Care provider by receipt of an electronic letter or paper letter
|
12 months
|
|
The proportion receiving an order to get a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter
Time Frame: 12 months
|
The proportion receiving an order to get a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter
|
12 months
|
|
The proportion completing a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter
Time Frame: 12 months
|
The proportion completing a low-dose computed tomography (LDCT) lung cancer screen (LCS) scan by receipt of an electronic letter or paper letter
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Debra Ritzwoller, PhD, Kaiser Permanente
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)
March 26, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
June 20, 2024
First Submitted That Met QC Criteria
June 20, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 21, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMP_LungCancerScreen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Quality Improvement study.
No individual participant data will be available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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