Inpatient Smokers and LDCT Screening RCT

NCT03276806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-07-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

tobacco dependence/smoking cessation counseling

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

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.

OTHER

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).

OTHER

LDCT brochure

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

Sponsors & Collaborators

  • American Lung Association

    collaborator OTHER
  • Boston University

    lead OTHER

Principal Investigators

  • Hasmeena Kathuria, MD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2019-04-01
Completion
2019-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03276806 on ClinicalTrials.gov