Clinical trial NCT06605534: Leveraging the Emergency Department (LEAD) Study
Official title: LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: screening
lung cancer
Disparities
social determinants of health
emergency department
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Cancer Research
First posted: 2024-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Lung Cancer Screening Uptake
timeFrame: Assessed at 1 month and 6 months post intervention
measure: Stage of Adoption for Lung Cancer Screening
timeFrame: Assessed at 1 week and then at 1 month and 6 months post intervention
Secondary outcomes:
measure: Health Literacy Scale
timeFrame: At one week and one month post intervention
measure: Medical Mistrust Scale
timeFrame: At one week and one month post intervention
measure: Perceived Stigma Scale
timeFrame: At one week and one month post intervention
measure: Perceived Risk of Lung Cancer Scale
timeFrame: At one week and one month post intervention
measure: Perceived Benefits of Lung Cancer Screening Scale
timeFrame: At one week and one month post intervention
measure: Perceived Barriers to Lung Cancer Screening Scale
timeFrame: At one week and one month post intervention
measure: Self-Efficacy for Lung Cancer Screening Scale
timeFrame: At one week and one month post intervention
measure: Knowledge: Lung Cancer and Screening Scale
timeFrame: At one week and one month post intervention
measure: Lung Cancer Fatalism
timeFrame: At one week and one month post intervention
Other outcomes:
Locations:
city: Brick
country: United States
facility: Ocean Medical Center
state: New Jersey
city: Edison
country: United States
facility: John F. Kennedy Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Holmdel
country: United States
facility: Bayshore Medical Center
state: New Jersey
city: Manahawkin
country: United States
facility: Southern Ocean Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: North Bergen
country: United States
facility: Palisades Medical Center
state: New Jersey
city: Old Bridge
country: United States
facility: Old Bridge Medical Center
state: New Jersey
city: Perth Amboy
country: United States
facility: Raritan Bay Medical Center
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Lisa Carter-Bawa, PhD
role: PRINCIPAL_INVESTIGATOR
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