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RECRUITING Not applicable ClinicalTrials.gov

Leveraging the Emergency Department (LEAD) Study

Sponsor: Hackensack Meridian Health • ClinicalTrials.gov ID: NCT06605534

Registry updated: 2026-09-08
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Description

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.

Interventions

  • LungTalk (Behavioral)
    Tailored lung screening intervention
  • Non-tailored lung screening (Other)
    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.

Eligibility criteria

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

Conditions

Lung Cancer

Locations

  • Ocean Medical Center — Brick, New Jersey, United States
  • John F. Kennedy Medical Center — Edison, New Jersey, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Bayshore Medical Center — Holmdel, New Jersey, United States
  • Southern Ocean Medical Center — Manahawkin, New Jersey, United States
  • Jersey Shore University Medical Center — Neptune City, New Jersey, United States
  • Palisades Medical Center — North Bergen, New Jersey, United States
  • Old Bridge Medical Center — Old Bridge, New Jersey, United States
  • Raritan Bay Medical Center — Perth Amboy, New Jersey, United States
  • Riverview Medical Center — Red Bank, New Jersey, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record