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Trial Title:
Leveraging the Emergency Department (LEAD) Study
NCT ID:
NCT06605534
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Emergencies
Conditions: Keywords:
screening
lung cancer
Disparities
social determinants of health
emergency department
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
LungTalk
Description:
Tailored lung screening intervention
Arm group label:
LungTalk Group
Intervention type:
Other
Intervention name:
Non-tailored lung screening
Description:
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.
Arm group label:
Non-tailored Lung Screening Pamphlet Group
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.
Criteria for 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
Gender:
All
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Hackensack Meridian Health
Agency class:
Other
Collaborator:
Agency:
New Jersey Commission on Cancer Research
Agency class:
Other
Source:
Hackensack Meridian Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06605534
