Clinical Trial

Leveraging the Emergency Department (LEAD) Study

Recruiting
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Summary
This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-09-18; most recent amendment 2026-02-06.
Status change: Not Yet Recruiting → Recruiting 2024-11-12
Trial Details
NCT Number NCT06605534
Lead Sponsor Hackensack Meridian Health
Collaborators: New Jersey Commission on Cancer Research
Conditions Lung Cancer
Enrollment 100 participants
Start Date 2024-10-29
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-10