Inpatient Smokers and LDCT Screening Part 2
Engaging Low SES Inpatient Smokers in LDCT Lung Cancer Screening: Enhanced Interventions That Include CHWs to Address SDH Barriers
2 other identifiers
interventional
21
1 country
1
Brief Summary
Lung cancer suffers from large racial and socioeconomic disparities. Yet those at the highest risk of lung cancer death - current smokers, blacks, and individuals with low socioeconomic status (SES) and negative social determinants of health (SDH) - are less likely to receive preventive health services, including the two most effective interventions to reduce lung cancer mortality: tobacco dependence treatment and lung cancer screening (LCS) with low-dose computed tomography (LDCT). At Boston Medical Center (BMC) these preventive services are grossly underutilized, in part due to barriers our patients face in accessing these outpatient programs. Innovative approaches are needed to guide high-risk smokers to post-discharge early lung cancer detection services. The overarching goal of this study is to reduce disparities in lung cancer morbidity and mortality by using hospitalization at an urban safety net hospital as an opportunity to connect high-risk smokers to both LDCT lung cancer screening and tobacco dependence treatment. In addition to inpatient shared decision making \[SDM\] by an NP using a decision aid, screen-eligible smokers will also be connected with a community health worker (CHW) to facilitate access to outpatient smoking cessation counseling and LCS (CHW navigation).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 4, 2019
CompletedStudy Start
First participant enrolled
February 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2020
CompletedJuly 7, 2020
July 1, 2020
12 months
January 3, 2019
July 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDCT screening within 3 months post randomization
Data will be collected from the electronic health record (EHR) and the BMC lung cancer screening (LDCT) database.
3 months
Secondary Outcomes (3)
Knowledge of LDCT screening
baseline, 24 hours post enrollment
Self-report smoking cessation
6 months
Biochemical validated smoking cessation
6 months
Study Arms (2)
Enhanced usual care
ACTIVE COMPARATORAll trial participants will receive smoking cessation counseling (standard of care) and will be given the AHRQ "Is Lung Cancer Screening Right for me?" patient decision aid to review independently while in the hospital.
Inpatient SDM + CHW Navigation
EXPERIMENTALIn addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.
Interventions
All participants will receive inpatient smoking cessation counseling by the tobacco-trained NP. Inpatient smoking cessation counseling is the standard of care at BMC.
The AHRQ "Is Lung Cancer Screening Right for me?" patient 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 tradeoffs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW)
During the smoking cessation consultation, the nurse practitioner (NP) will conduct SDM, using the 4-page AHRQ "Is Lung Cancer Screening Right for me?" decision aid as a guide. The purpose of SDM is three-fold: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with Centers for Medicare \& Medicaid Services (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.
The CHW will meet with the participant after the SDM to initiate the coordination of outpatient tobacco treatment, referral to LCS, and resources to address the barriers to preventive services. The CHW will follow patients subjects in the intervention arm for 3 months to help navigate and address negative social determinants of health that are barriers to LCS and tobacco treatment. For patients who agree to screening, the CHW will schedule the appointment, arrange the transportation to appointment, and meet participant at the appointment to facilitate the screening.
Eligibility Criteria
You may qualify if:
- Hospitalized smoker at BMC
- Meeting LDCT screening eligibility criteria: (age 55-80 years; ≥30-pack years smoking)
- Current smoker (\> 1 cigarette per day)
- Able to speak, read, and understand English
- Able and willing to comply with all study protocols and procedures
- Having a PCP in the BMC network or one of the affiliated health centers
You may not qualify if:
- Inability to tolerate surgical resection of a lung cancer, as defined by home oxygen therapy (an indicator of severe lung cancer or heart disease)
- Active cancer (receiving treatment/new diagnosis) in prior 3 months or advanced stage cancer
- Signs and symptoms of lung cancer or prior diagnosis of lung cancer
- Already had chest CT (LDCT screening or other chest CT) in the past year
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- American Lung Associationcollaborator
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
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: 35997854DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hasmeena Kathuria, MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2019
First Posted
January 4, 2019
Study Start
February 12, 2019
Primary Completion
January 28, 2020
Study Completion
June 4, 2020
Last Updated
July 7, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share