Inpatient Smokers and LDCT Screening Part 2



Status:Enrolling by invitation
Conditions:Lung Cancer, Smoking Cessation
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:55 - 80
Updated:3/21/2019
Start Date:February 12, 2019
End Date:June 2020

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Engaging Low SES Inpatient Smokers in LDCT Lung Cancer Screening: Enhanced Interventions That Include CHWs to Address SDH Barriers

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).

This study is a randomized controlled trial (RCT) among 128 hospitalized smokers at BMC (64
participants in each of two arms), to assess the effect of inpatient SDM + CHW Navigation
(AHRQ LDCT screening decision aid + CHW + SDM discussion + smoking cessation counseling)
compared to Enhanced Usual Care (smoking cessation counseling + decision aid) on LDCT
screening completion at 3 months, patient knowledge, and smoking cessation at 6 months.

The research will meet two specific aims (SA1 and SA2).

SA1: To address barriers to engaging smokers in prevention and early detection of lung
cancer, a pilot RCT (Pilot Study 2) will be conducted in which screen-eligible hospitalized
smokers will be randomized to receive inpatient sdm + CHW navigation (inpatient SDM during
smoking cessation counseling visits + CHW navigation to coordinate outpatient tobacco
treatment, referral to LCS, and resources to address negative social determinant of health
that present barriers to these preventive services) or Enhanced usual care (furnishing of
LDCT screening decision aid during inpatient smoking cessation counseling visits). Compared
to Enhanced Usual Care, it is hypothesized that inpatient sdm + CHW navigation will increase
the number of patients completing LCS (1° outcome) and LCS knowledge, and biochemically
validated smoking cessation at 6 months (2° outcome).

SA2: To collect stakeholder input to inform future implementation, Fifteen primary care
providers (PCPs) will be interviewed to assess their impressions of the intervention,
integration into workflow, and barriers to adoption. Fifteen smokers who received the
intervention will be interviewed to learn their impressions of its utility and suggestions
for improvement.

Inclusion Criteria:

1. Hospitalized smoker at BMC

2. Meeting LDCT screening eligibility criteria: (age 55-80 years; ≥30-pack years smoking)

3. Current smoker (> 1 cigarette per day)

4. Able to speak, read, and understand English

5. Able and willing to comply with all study protocols and procedures

6. Having a PCP in the BMC network or one of the affiliated health centers

Exclusion Criteria:

1. Inability to tolerate surgical resection of a lung cancer, as defined by home oxygen
therapy (an indicator of severe lung cancer or heart disease)

2. Active cancer (receiving treatment/new diagnosis) in prior 3 months or advanced stage
cancer

3. Signs and symptoms of lung cancer or prior diagnosis of lung cancer

4. Already had chest CT (LDCT screening or other chest CT) in the past year

5. Pregnant
We found this trial at
1
site
Boston, Massachusetts 02118
Phone: 617-638-4906
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from
Boston, MA
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