Leveraging the Emergency Department (LEAD) Study

Hackensack Meridian Health

Status: Enrolling

Conditions: Lung Cancer

Treatments: Behavioral: LungTalk; Other: Non-tailored lung screening

Study type: Interventional

Funder types: Other

Identifiers

NCT06605534

Pro2024-0236

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

LungTalk Group

Experimental group

Description:

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.

Treatment:

Behavioral: LungTalk

Non-tailored Lung Screening Pamphlet Group

Active Comparator group

Description:

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.

Treatment:

Other: Non-tailored lung screening