Inpatient Smokers and LDCT Screening RCT

NCT03276806 | Completed

• 2 other identifiers: H-36854LCD-507875
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Shared Decision Making

Keywords

CT low dose; nurse led intervention; safety net hospital; lung cancer screening with CTLD

Outcome Measures

Primary Outcomes (1)

• Completion of LDCT screening

  The electronic records review and from the Lung Cancer Screening clinical database created by the Department of Pulmonary Disease and Critical Care at BMC will be reviewed to determine which participants have completed LDCT screening designated as yes or no and if yes the date of the LDCT screening will be recorded..

  3 months

Secondary Outcomes (3)

• Knowledge of LDCT screening (experimental group)

  Baseline, immediately post SDM, 1 month

• Knowledge of LDCT screening (active comparator group)

  Baseline, 1 month

• smoking cessation

  4 weeks

Study Arms (2)

SDM + decision aid + tobacco counseling

EXPERIMENTAL

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

Behavioral: tobacco dependence/smoking cessation counseling; Behavioral: SDM; Other: Decision Aid

LDCT brochure + tobacco counseling

ACTIVE COMPARATOR

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

Behavioral: tobacco dependence/smoking cessation counseling; Other: LDCT brochure

Interventions

tobacco dependence/smoking cessation counseling BEHAVIORAL

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

LDCT brochure + tobacco counseling; SDM + decision aid + tobacco counseling

SDM 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.

Also known as: Shared decision making

SDM + decision aid + tobacco counseling

Decision Aid 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).

SDM + decision aid + tobacco counseling

LDCT brochure OTHER

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

LDCT brochure + tobacco counseling

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• American Lung Association: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 35997854 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

SDM; Decision Support Techniques

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hasmeena Kathuria, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: November 7, 2017
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)