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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Ocean Medical Center
RECRUITING
Brick
John F. Kennedy Medical Center
RECRUITING
Edison
Hackensack University Medical Center
RECRUITING
Hackensack
Bayshore Medical Center
RECRUITING
Holmdel
Southern Ocean Medical Center
RECRUITING
Manahawkin
Jersey Shore University Medical Center
RECRUITING
Neptune City
Palisades Medical Center
RECRUITING
North Bergen
Old Bridge Medical Center
RECRUITING
Old Bridge
Raritan Bay Medical Center
RECRUITING
Perth Amboy
Riverview Medical Center
RECRUITING
Red Bank
Contact Information
Primary
Ana Guadalupe Vielma, PhD
ana.vielma@hmh-cdi.org
2018803400
Backup
Francis Valenzona
francis.valenzona@hmh-cdi.org
2018803400
Time Frame
Start Date: 2024-10-29
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 100
Treatments
Experimental: LungTalk Group
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.
Active_comparator: Non-tailored Lung Screening Pamphlet Group
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.
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health
Collaborators: New Jersey Commission on Cancer Research

This content was sourced from clinicaltrials.gov