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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
100
Tailored lung screening intervention
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.
Ocean Medical Center
Brick, New Jersey, United States
RECRUITINGJohn F. Kennedy Medical Center
Edison, New Jersey, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
RECRUITINGBayshore Medical Center
Holmdel, New Jersey, United States
RECRUITINGSouthern Ocean Medical Center
Manahawkin, New Jersey, United States
RECRUITINGJersey Shore University Medical Center
Neptune City, New Jersey, United States
RECRUITINGPalisades Medical Center
North Bergen, New Jersey, United States
RECRUITINGOld Bridge Medical Center
Old Bridge, New Jersey, United States
RECRUITINGRaritan Bay Medical Center
Perth Amboy, New Jersey, United States
RECRUITINGRiverview Medical Center
Red Bank, New Jersey, United States
RECRUITINGLung Cancer Screening Uptake
Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR))
Time frame: Assessed at 1 month and 6 months post intervention
Stage of Adoption for Lung Cancer Screening
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.
Time frame: Assessed at 1 week and then at 1 month and 6 months post intervention
Health Literacy Scale
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.
Time frame: At one week and one month post intervention
Medical Mistrust Scale
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.
Time frame: At one week and one month post intervention
Perceived Stigma Scale
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.
Time frame: At one week and one month post intervention
Perceived Risk of Lung Cancer Scale
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.
Time frame: At one week and one month post intervention
Perceived Benefits of Lung Cancer Screening Scale
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
Time frame: At one week and one month post intervention
Perceived Barriers to Lung Cancer Screening Scale
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
Time frame: At one week and one month post intervention
Self-Efficacy for Lung Cancer Screening Scale
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.
Time frame: At one week and one month post intervention
Knowledge: Lung Cancer and Screening Scale
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.
Time frame: At one week and one month post intervention
Lung Cancer Fatalism
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.
Time frame: At one week and one month post intervention
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