A Community Health Worker Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers

BEHAVIORAL

Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation

The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatmnet counseling, and 4) navigation of logistical barriers

BEHAVIORAL

Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation

The lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers

OTHER

Enhanced Usual Care

Participants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider.

Feasibility: Number of participants at each stage of the recruitment and retention cascade

Time frame: once a month until study trial ends, an average one year

Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.

Feasibility: Percentage of participants at each stage of the recruitment and retention cascade

Time frame: once a month until study trial ends, an average one year

Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.

Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter

Time frame: once a month until study trial ends, an average of 1 year

Time in minutes spent on SDM, recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.

Fidelity: Duration in minutes of smoking cessation counseling per encounter

Time frame: once a month until study trial ends, an average of 1 year

Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.

Fidelity - SDM quality using OPTION Scale Observer OPTION Scale

Time frame: once a month until study trial ends, an average of 1 year

Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.

Fidelity - Completion of SDM required elements

Time frame: once a month until study trial ends, an average of 1 year

Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.

Fidelity: Percentage of participants with documented use of the SDM decision aid

Time frame: Monthly through study completion, an average of 1 year

Proportion of participants for whom the SDM decision aid was used, documented in the CHW and lay navigator encounter log.

Fidelity: Percentage of participants referred to tobacco treatment services, by type

Time frame: Monthly through study completion, an average of 1 year

Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW and lay navigator encounter log.

Acceptability of the CHW and lay navigator intervention to participants

Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)

Qualitative themes regarding overall experience with the CHW and lay navigator intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), \~40-45 minutes, conducted in private at 3-month follow-up;

Acceptability of the intervention to CHWs and Lay navigators

Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)

Qualitative themes regarding overall experience with the Naviagtor intervention and barriers to lung cancer screening, identified through thematic analysis of Navigator encounter logs and semi-structured interviews using a study-specific interview guide. Navigators (N=3), one 45-minute interview each after final intervention delivery.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.