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Inpatient Smokers and LDCT Screening RCT

Primary Purpose

Lung Cancer, Shared Decision Making

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tobacco dependence/smoking cessation counseling
SDM
Decision Aid
LDCT brochure
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring CT low dose, nurse led intervention, safety net hospital, lung cancer screening with CTLD

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SDM + decision aid + tobacco counseling

LDCT brochure + tobacco counseling

Arm Description

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

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

Outcomes

Primary Outcome Measures

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..

Secondary Outcome Measures

Knowledge of LDCT screening (experimental group)
A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening. The mean percentage of correct responses will be measured so higher scores are better suggesting more knowledge about LDCT screening.
Knowledge of LDCT screening (active comparator group)
A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening.
smoking cessation
Dichotomous outcome by self-report of prolonged abstinence at 4 weeks and 7-day point prevalence at 4 weeks, as recommended by the Society for Research on Nicotine and Tobacco and the Russell Standard.

Full Information

First Posted
September 5, 2017
Last Updated
July 2, 2019
Sponsor
Boston University
Collaborators
American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT03276806
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
American Lung Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Shared Decision Making
Keywords
CT low dose, nurse led intervention, safety net hospital, lung cancer screening with CTLD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SDM + decision aid + tobacco counseling
Arm Type
Experimental
Arm Description
Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.
Arm Title
LDCT brochure + tobacco counseling
Arm Type
Active Comparator
Arm Description
Participants will receive tobacco dependence/smoking cessation counseling by a nurse and a LDCT informational brochure.
Intervention Type
Behavioral
Intervention Name(s)
tobacco dependence/smoking cessation counseling
Intervention Description
Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.
Intervention Type
Behavioral
Intervention Name(s)
SDM
Other Intervention Name(s)
Shared decision making
Intervention Description
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
Other
Intervention Name(s)
Decision Aid
Intervention Description
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
Intervention Name(s)
LDCT brochure
Intervention Description
A informational brochure developed by the BMC screening program about low dose CT screening for lung cancer.
Primary Outcome Measure Information:
Title
Completion of LDCT screening
Description
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..
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Knowledge of LDCT screening (experimental group)
Description
A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening. The mean percentage of correct responses will be measured so higher scores are better suggesting more knowledge about LDCT screening.
Time Frame
Baseline, immediately post SDM, 1 month
Title
Knowledge of LDCT screening (active comparator group)
Description
A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening.
Time Frame
Baseline, 1 month
Title
smoking cessation
Description
Dichotomous outcome by self-report of prolonged abstinence at 4 weeks and 7-day point prevalence at 4 weeks, as recommended by the Society for Research on Nicotine and Tobacco and the Russell Standard.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasmeena Kathuria, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35997854
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.
Results Reference
derived

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Inpatient Smokers and LDCT Screening RCT

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