Leveraging the Emergency Department (LEAD) Study

February 6, 2026 updated by: Hackensack Meridian Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Recruiting
        • Ocean Medical Center
        • Contact:
      • Edison, New Jersey, United States, 08820
        • Recruiting
        • John F. Kennedy Medical Center
        • Contact:
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
      • Holmdel, New Jersey, United States, 07733
        • Recruiting
        • Bayshore Medical Center
        • Contact:
      • Manahawkin, New Jersey, United States, 08050
        • Recruiting
        • Southern Ocean Medical Center
        • Contact:
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore University Medical Center
        • Contact:
      • North Bergen, New Jersey, United States, 07047
        • Recruiting
        • Palisades Medical Center
        • Contact:
      • Old Bridge, New Jersey, United States, 08857
        • Recruiting
        • Old Bridge Medical Center
        • Contact:
      • Perth Amboy, New Jersey, United States, 08861
        • Recruiting
        • Raritan Bay Medical Center
        • Contact:
      • Red Bank, New Jersey, United States, 07701
        • Recruiting
        • Riverview Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: LungTalk
Tailored lung screening intervention
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.
Other: Non-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Cancer Screening Uptake
Time Frame: Assessed at 1 month and 6 months post intervention
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
Time Frame: Assessed at 1 week and then at 1 month and 6 months post intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Literacy Scale
Time Frame: At one week and one month post intervention
Change in Health Literacy Scale between baseline and 1 week and 1-month post-intervention. The Health Literacy Scale will be measured using the 3-item psychometrically validated Health Literacy Scale by Chew and colleagues. This scale has been supported as valid for detecting inadequate health literacy using Likert scale response options ranging from 0=strongly disagree to 4 =strongly agree with lower scores representative of higher levels of health literacy.
At one week and one month post intervention
Medical Mistrust Scale
Time Frame: At one week and one month post intervention
Change in Medical Mistrust Scale between baseline and 1 week and 1-month post-intervention. Medical Mistrust will be measured using the psychometrically validated 5-item Medical Mistrust Scale. This measure assesses constructs related to mistrust of the medical system, including suspicion, discrimination, and lack of support. Likert scale response options range from 1 to 4 with 1=Stongly Disagree to Agree 5=Strongly. Responses are summed (range 5-25), with higher scores indicating more trust. *Negatively worded item is reverse coded. Reliability and validity have been well established with Cronbach's alpha of 0.87-0.88.
At one week and one month post intervention
Perceived Stigma Scale
Time Frame: At one week and one month post intervention
Change in Perceived Stigma Scale between baseline and 1 week and 1-month post-intervention. Perceived Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale. The response scale is 1=strongly disagree to 4=strongly agree; range is 5 to 25 (higher stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.
At one week and one month post intervention
Perceived Risk of Lung Cancer Scale
Time Frame: At one week and one month post intervention
Change in Perceived Risk of Lung Cancer Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Risk of Lung Cancer on a 3-item scale with Likert-type responses from 1=Strongly Disagree to 4=Strongly Agree. The range of scores is 3 to 12 (higher perceived risk of lung cancer). Cronbach's alpha was 0.88 in our preliminary study.
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
Change in Perceived Benefits of Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Benefits of Lung Cancer Screening on a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits), with a Cronbach's alpha of 0.76 in our preliminary study
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
Change in Perceived Barriers of Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers) with a Cronbach's a of 0.87 in our preliminary psychometric study
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
Change in Self-Efficacy for Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Self-Efficacy for Lung Cancer Screening. This scale has nine items with a four-point Likert response option (1=Not at all Confident and 4 =Very Confident) to assess individual beliefs about ability to arrange and complete an LDCT to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy) with a Cronbach's alpha of 0.92 in our preliminary psychometric study.
At one week and one month post intervention
Knowledge: Lung Cancer and Screening Scale
Time Frame: At one week and one month post intervention
Change in Knowledge: Lung Cancer and Lung Screening between baseline and 1 week and 1-month post-intervention. Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. The range of scores is 0 to 7, with 0 being No Knowledge, and 9 being Complete Knowledge.
At one week and one month post intervention
Lung Cancer Fatalism
Time Frame: At one week and one month post intervention
Change in Lung Cancer Fatalism between baseline and 1 week and 1-month post-intervention. Lung Cancer Fatalism will be measured with the 11-item dichotomous (0=yes and 1=no) Lung Cancer Fatalism Scale adapted from the Revised Powe Fatalism Inventory that has been psychometrically validated.
At one week and one month post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

New Jersey Commission on Cancer Research

Investigators

  • Principal Investigator: Lisa Carter-Bawa, PhD, Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2024-0236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on LungTalk

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe