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RecruitingInterventional

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

NCT ID: NCT06605534Sponsor: Hackensack Meridian HealthLast updated: 2026-02-10

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.

Arms & 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.

Outcome measures

Primary

  • Lung Cancer Screening Uptake

    Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR))

    Time frame: Assessed at 1 month and 6 months post intervention

  • Stage of Adoption for Lung Cancer Screening

    Screening Intention will be assessed with the Stage of Adoption for Decision- Making About Lung Screening using an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow investigators to assess intent.

    Time frame: Assessed at 1 week and then at 1 month and 6 months post intervention

Secondary

  • Health Literacy Scale

    Time frame: At one week and one month post intervention

  • Medical Mistrust Scale

    Time frame: At one week and one month post intervention

  • Perceived Stigma Scale

    Time frame: At one week and one month post intervention

  • Perceived Risk of Lung Cancer Scale

    Time frame: At one week and one month post intervention

  • Perceived Benefits of Lung Cancer Screening Scale

    Time frame: At one week and one month post intervention

  • Perceived Barriers to Lung Cancer Screening Scale

    Time frame: At one week and one month post intervention

  • Self-Efficacy for Lung Cancer Screening Scale

    Time frame: At one week and one month post intervention

  • Knowledge: Lung Cancer and Screening Scale

    Time frame: At one week and one month post intervention

  • Lung Cancer Fatalism

    Time frame: At one week and one month post intervention

Eligibility criteria

Sex: AllAge: 50 Years to 80 YearsHealthy volunteers: No
Inclusion Criteria: * Aged 50 years to 80 years * Currently smoke cigarettes or quit smoking cigarettes within the past 15 years * 20 pack-year smoking history * Has never had lung cancer screening * Able to provide informed consent * Able to speak and understand English Exclusion Criteria: * Diagnosed with lung cancer * Has a history of having a lung cancer screening scan * Unable to speak and understand English

Study locations (10)

Ocean Medical Center

Brick, New Jersey, 08724

Recruiting

John F. Kennedy Medical Center

Edison, New Jersey, 08820

Recruiting

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Bayshore Medical Center

Holmdel, New Jersey, 07733

Recruiting

Southern Ocean Medical Center

Manahawkin, New Jersey, 08050

Recruiting

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753

Recruiting

Palisades Medical Center

North Bergen, New Jersey, 07047

Recruiting

Old Bridge Medical Center

Old Bridge, New Jersey, 08857

Recruiting

Raritan Bay Medical Center

Perth Amboy, New Jersey, 08861

Recruiting

Riverview Medical Center

Red Bank, New Jersey, 07701

Recruiting

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