Inpatient Smokers and LDCT Screening RCT

NCT ID: NCT03276806

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-07
• Study Completion Date: 2019-07-01

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.

Conditions

Lung Cancer; Shared Decision Making

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SDM + decision aid + tobacco counseling

Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.

Group Type: EXPERIMENTAL

tobacco dependence/smoking cessation counseling

Intervention Type: BEHAVIORAL

Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.

SDM

Intervention Type: BEHAVIORAL

SDM is three-fold to: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with CMS requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context.

Decision Aid

Intervention Type: OTHER

The decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about trade-offs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW).

LDCT brochure + tobacco counseling

Participants will receive tobacco dependence/smoking cessation counseling by a nurse and a LDCT informational brochure.

Group Type: ACTIVE_COMPARATOR

tobacco dependence/smoking cessation counseling

Intervention Type: BEHAVIORAL

Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.

LDCT brochure

Intervention Type: OTHER

A informational brochure developed by the BMC screening program about low dose CT screening for lung cancer.

Interventions

tobacco dependence/smoking cessation counseling

Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.

Intervention Type: BEHAVIORAL

SDM

SDM is three-fold to: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with CMS requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context.

Intervention Type: BEHAVIORAL

Decision Aid

The decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about trade-offs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW).

Intervention Type: OTHER

LDCT brochure

A informational brochure developed by the BMC screening program about low dose CT screening for lung cancer.

Intervention Type: OTHER

Other Intervention Names

Shared decision making

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Lung Association

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hasmeena Kathuria, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35997854 (View on PubMed)

Other Identifiers

LCD-507875

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-36854

Identifier Type: -

Identifier Source: org_study_id