RecruitingNot ApplicableNCT06605534

Leveraging the Emergency Department (LEAD) Study

LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities

Sponsor

Hackensack Meridian Health

Enrollment

100 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the emergency department (ED) can be used as a place to identify and encourage high-risk individuals to get screened for lung cancer. Eligible patients who have never been screened before will be offered information and support to access a low-dose CT scan, which can detect lung cancer early. **You may be eligible if...** - You are between 50 and 80 years old - You currently smoke cigarettes, or you quit within the past 15 years - You have a smoking history of at least 20 pack-years (e.g., 1 pack/day for 20 years) - You have never had a lung cancer screening scan before - You can speak and understand English - You can give informed consent **You may NOT be eligible if...** - You have already been diagnosed with lung cancer - You have already had a lung cancer screening scan in the past - You cannot speak or understand English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLungTalk

Tailored lung screening intervention

OTHERNon-tailored lung screening

Non-tailored lung screening. It involves the addition of education to Social Determinants of Health (SDOH) screening and referral with patient navigation. Patients will be identified, and screened for SDOH needs using the UniteUs SDOH screener that is embedded in the Electronic Health Record (EHR), and connected to geographically-tailored resources (as described above under Arm 1). Participants will then be sent a non-tailored lung screening educational brochure via email to review that details lung cancer risk, lung screening facts, benefits, and potential harms. Within 48 hours, the Community Outreach and Engagement (COE) Patient Navigator will contact the patient to answer questions and provide navigation services as described above in Arm 1.