Leveraging the Emergency Department (LEAD) Study

NCT06605534 | Recruiting

• 1 other identifier: Pro2024-0236
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Lung Cancer

Keywords

screening; lung cancer; Disparities; social determinants of health; emergency department

Outcome Measures

Primary Outcomes (2)

• Lung Cancer Screening Uptake

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

  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.

  Assessed at 1 week and then at 1 month and 6 months post intervention

Secondary Outcomes (9)

• Health Literacy Scale

  At one week and one month post intervention

• Medical Mistrust Scale

  At one week and one month post intervention

• Perceived Stigma Scale

  At one week and one month post intervention

• Perceived Risk of Lung Cancer Scale

  At one week and one month post intervention

• Perceived Benefits of Lung Cancer Screening Scale

  At one week and one month post intervention

Study Arms (2)

LungTalk Group

EXPERIMENTAL

LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled Lung Cancer Screening (LCS) knowledge and health beliefs (p \< 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03.

Behavioral: LungTalk

Non-tailored Lung Screening Pamphlet Group

ACTIVE COMPARATOR

Non-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings.

Other: Non-tailored lung screening

Interventions

LungTalk BEHAVIORAL

Tailored lung screening intervention

LungTalk Group

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.

Non-tailored Lung Screening Pamphlet Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 years to 80 years
• Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
• pack-year smoking history
• Has never had lung cancer screening
• Able to provide informed consent
• Able to speak and understand English

You may not qualify if:

• Diagnosed with lung cancer
• Has a history of having a lung cancer screening scan
• Unable to speak and understand English

Sponsors & Collaborators

• New Jersey Commission on Cancer Research: collaborator
• Hackensack Meridian Health: lead

Study Sites (10)

Ocean Medical Center

Brick, New Jersey, 08724, United States

RECRUITING

John F. Kennedy Medical Center

Edison, New Jersey, 08820, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Bayshore Medical Center

Holmdel, New Jersey, 07733, United States

RECRUITING

Southern Ocean Medical Center

Manahawkin, New Jersey, 08050, United States

RECRUITING

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

RECRUITING

Palisades Medical Center

North Bergen, New Jersey, 07047, United States

RECRUITING

Old Bridge Medical Center

Old Bridge, New Jersey, 08857, United States

RECRUITING

Raritan Bay Medical Center

Perth Amboy, New Jersey, 08861, United States

RECRUITING

Riverview Medical Center

Red Bank, New Jersey, 07701, United States

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Emergencies

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Carter-Bawa, PhD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Guadalupe Vielma, PhD

CONTACT

2018803400; ana.vielma@hmh-cdi.org

Francis Valenzona

CONTACT

2018803400; francis.valenzona@hmh-cdi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 20, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)