Improving Utilization of Lung Cancer Screening in Underserved PA Populations

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Other: Educational Materials and Decision Counseling

• Registration Number: NCT04806399
• Lead Sponsor: American College of Radiology

Brief Summary

This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

Detailed Description

The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Study Start: 2023-03-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Have an upcoming office visit with a primary care physician in one of the study practices
• Between the ages of 50 and 77 (inclusive)
• History of smoking (current or former) in the electronic medical record (EMR)

Exclusion Criteria

• Chest CT performed in the last 10 months before study initiation according to EMR
• Diagnosis of lung cancer indicated in the problem list in the EMR
• Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outreach Contact with Decision Counseling Group	Educational Materials and Decision Counseling	-

Primary Outcome Measures

Name	Time	Method
Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.	24 months	Implement a centralized outreach intervention that includes shared decision-making (SDM) about lung cancer screening (LCS) (screening eligibility assessment, education, and decision support) in LCS-eligible primary care patients. The study's ultimate goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

Trial Locations

Locations (2)

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Jefferson Health System; 🇺🇸 Philadelphia, Pennsylvania, United States