Inpatient Smokers and LDCT Screening Part 2

Not Applicable

Completed

• Conditions: Smoking Cessation; Lung Cancer Screening
• Interventions: Behavioral: Smoking Cessation Counseling; Behavioral: Decision Aid; Behavioral: Shared decision making (SDM); Behavioral: CHW Navigation

• Registration Number: NCT03793894
• Lead Sponsor: Boston University

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Study Start: 2019-02-12
• Primary Completion: 2020-01-28
• Study Completion: 2020-06-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatient SDM + CHW Navigation	Shared decision making (SDM)	In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.
Inpatient SDM + CHW Navigation	Decision Aid	In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.
Inpatient SDM + CHW Navigation	CHW Navigation	In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.
Enhanced usual care	Smoking Cessation Counseling	All 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.
Enhanced usual care	Decision Aid	All 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	Smoking Cessation Counseling	In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.

Primary Outcome Measures

Name	Time	Method
LDCT screening within 3 months post randomization	3 months	Data will be collected from the electronic health record (EHR) and the BMC lung cancer screening (LDCT) database.

Secondary Outcome Measures

Name	Time	Method
Knowledge of LDCT screening	baseline, 24 hours post enrollment	Knowledge about LDCT screening will be measured with a 23-item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening.
Biochemical validated smoking cessation	6 months	Participants who self-report quitting will be invited to complete the CO test for biochemical verification. This dichotomous outcome will be defined by biochemically verified 7-day point prevalence abstinence at 6 months. At study end, participants will be identified as smokers who 1) self-report abstinence, but are identified as smokers via biochemical validation (CO level \>10 ppm), or 2) self-report abstinence, but refuse biochemical verification.
Self-report smoking cessation	6 months	Participants will be asked during telephone interview if they are smoking.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States