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Inpatient Smokers and LDCT Screening Part 2

Primary Purpose

Lung Cancer Screening, Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Cessation Counseling
Decision Aid
Shared decision making (SDM)
CHW Navigation
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer Screening focused on measuring Community health worker (CHW), Shared decision making (SDM), Low-dose computed tomography (LDCT)

Eligibility Criteria

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

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced usual care

Inpatient SDM + CHW Navigation

Arm Description

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.

In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Knowledge of LDCT screening
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.
Self-report smoking cessation
Participants will be asked during telephone interview if they are smoking.
Biochemical validated smoking cessation
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.

Full Information

First Posted
January 3, 2019
Last Updated
July 6, 2020
Sponsor
Boston University
Collaborators
American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT03793894
Brief Title
Inpatient Smokers and LDCT Screening Part 2
Official Title
Engaging Low SES Inpatient Smokers in LDCT Lung Cancer Screening: Enhanced Interventions That Include CHWs to Address SDH Barriers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
January 28, 2020 (Actual)
Study Completion Date
June 4, 2020 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Screening, Smoking Cessation
Keywords
Community health worker (CHW), Shared decision making (SDM), Low-dose computed tomography (LDCT)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inpatient SDM + CHW Navigation
Arm Type
Experimental
Arm Description
In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation Counseling
Intervention Description
All participants will receive inpatient smoking cessation counseling by the tobacco-trained NP. Inpatient smoking cessation counseling is the standard of care at BMC.
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Shared decision making (SDM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CHW Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
LDCT screening within 3 months post randomization
Description
Data will be collected from the electronic health record (EHR) and the BMC lung cancer screening (LDCT) database.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Knowledge of LDCT screening
Description
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.
Time Frame
baseline, 24 hours post enrollment
Title
Self-report smoking cessation
Description
Participants will be asked during telephone interview if they are smoking.
Time Frame
6 months
Title
Biochemical validated smoking cessation
Description
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.
Time Frame
6 months

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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasmeena Kathuria, MD
Organizational Affiliation
Boston Medical Center
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

Learn more about this trial

Inpatient Smokers and LDCT Screening Part 2

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