Clinical trial NCT03276806: Inpatient Smokers and LDCT Screening RCT
Official title: Capitalizing on Hospitalization to Engage Low SES Smokers in LDCT Screening: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Shared Decision Making
Keywords: CT low dose
nurse led intervention
safety net hospital
lung cancer screening with CTLD
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2017-09-08
Enrollment: 102
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully quit smoking derive the greatest reduction in lung cancer mortality. Unfortunately, those at highest risk of lung cancer death- those with low socioeconomic status, blacks, and current smokers- are the same individuals that typically have reduced access to preventive healthcare such as smoking cessation services and screening tests. Furthermore, patients from underserved communities often have lower health literacy, less awareness of lung cancer screening, and a poor understanding of the trade-offs of LDCT screening. In 2015 the Center for Medicare and Medicaid Services began requiring (1) a shared decision-making (SDM) discussion including use of a patient decision aid and (2) smoking cessation counseling in order to receive reimbursement for LDCT screening. There is little guidance, however, to help healthcare systems implement this requirement. Furthermore, primary care physicians (PCPs) report time constraints, competing demands, and knowledge deficiencies as barriers to optimizing utilization of LDCT screening.

Detailed description: The goal of this study is to create and evaluate an intervention that capitalizes on hospitalization at an urban safety net hospital as an opportunity to connect high risk smokers to lung cancer screening and smoking cessation services. Building on the well-established inpatient tobacco dependence consult service at Boston Medical Center, the investigators will study the effect of adding a nurse-driven LDCT screening SDM intervention to inpatient smoking cessation counseling among screen-eligible hospitalized smokers. Hospitalization may be an ideal time-point for this intervention as it offers 1) a "teachable moment" for patients, when they may be particularly receptive to interventions to reduce smoking-related disease, and 2) an opportunity to offload busy PCPs of the obligation to conduct SDM for LDCT screening.

In Aim 1, screen-eligible patients who are smokers will be randomized into one of the study arms (n=284, 142 per arm) to receive either inpatient 1) SDM (SDM by a thoracic oncology nurse using a decision aid) or 2) usual care and a LDCT informational brochure during inpatient smoking cessation consultation visits. In both arms the thoracic oncology nurse will counsel patients on smoking cessation. The investigators hypothesize that for screen-eligible smokers, inpatient SDM will increase (1) LDCT screening rates, (2) patient knowledge of LDCT screening, and (3) 1 month smoking quit rates compared to usual care.

In Aim 2, the potential for future implementation of the intervention will be evaluated by incorporating stakeholder impressions of the intervention through qualitative interviews. By study end, an inpatient intervention will be created to promote both LDCT screening and smoking cessation among low income and minority smokers. This hybrid study will allow te investigators to establish not only the effectiveness of the intervention, but also help inform future implementation.

Eligibility criteria: Inclusion Criteria:

* hospitalized smokers at BMC meeting LDCT screening eligible criteria
* males and females 55-80 years of age
* ≥30-pack years smoking
* current smoker
* able to speak, read, and understand English
* able and willing to participate and provide informed consent

Exclusion Criteria:

* severe co-morbidities expected to limit life expectancy or ability to tolerate surgical resection of a lung cancer, including patients requiring home oxygen therapy (an indicator of severe lung or heart disease), and patients with active cancer
* patients who have already had LDCT screening in the past year

Primary outcomes:
measure: Completion of LDCT screening
timeFrame: 3 months
Secondary outcomes:
measure: Knowledge of LDCT screening (experimental group)
timeFrame: Baseline, immediately post SDM, 1 month
measure: Knowledge of LDCT screening (active comparator group)
timeFrame: Baseline, 1 month
measure: smoking cessation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Assistant Professor
name: Hasmeena Kathuria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kathuria H, Gunawan A, Spring M, Aijaz S, Cobb V, Fitzgerald C, Wakeman C, Howard J, Clancy M, Foreman AG, Truong V, Wong C, Steiling K, Lasser KE, Bulekova K, Wiener RS. Hospitalization as an opportunity to engage underserved individuals in shared decision-making for lung cancer screening: results from two randomized pilot trials. Cancer Causes Control. 2022 Nov;33(11):1373-1380. doi: 10.1007/s10552-022-01620-8. Epub 2022 Aug 23.