Inpatient Capture: a Mixed Methods Study to Develop an Inpatient Lung Cancer Screening Program in a Safety Net Hospital.

Lung cancer continues to be the leading cause of cancer death in the United States. There are several important disparities in lung cancer mortality: racial and ethnic minorities, those with serious mental illness and those with lower socioeconomic status experience higher lung cancer mortality compared to the general population. Lung cancer screening (LCS) with annual low dose chest CT can reduce lung cancer mortality by 20% for high-risk patients, but has been generally underutilized with uptake of 5-15% by eligible patients across the United States. Half of all patients eligible for LCS remain current smokers, and the additional benefits of tobacco cessation services can increase the benefits of LCS clinical encounters in these patients. Despite the proven benefit of LCS and tobacco cessation, it remains out of reach for many with barriers across the patient, provider, and health-care system levels with resultant disparities in uptake of LCS and effective tobacco cessation that may exaggerate disparities in clinical lung cancer early detection and mortality. The majority of LCS care occurs across several visits in an outpatient clinical setting, which may make it inaccessible to the most vulnerable patients.

Our central objective is to extend the reach of lung cancer and tobacco screening through the implementation and evaluation of a program extending these services inpatient in a public hospital that serves a known high-risk and diverse population in East Harlem. Preliminary data obtained from a retrospective quality improvement project examined data from patients admitted over a 3 month period in early 2022. Of 1374 unique patients were admitted to our hospital, 112 patients met LCS eligibility criteria and over 80% had no evidence of having been screened. Forty-seven percent identified as Black and 33.9% as Hispanic, groups known to have worse lung cancer outcomes. While smoking data was incomplete on a majority of patients, 75% of all inpatient admissions were noted to be currently smoking. This, our preliminary data suggest that an inpatient program to provide smoking cessation and LCS in a safety-net hospital may be an effective tool to increase the reach of LCS in a known high-risk demographic and address disparities in LCS and tobacco cessation services.

This proposal represents a prospective pilot study to develop, implement and evaluate an inpatient LCS and tobacco cessation program.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Screening Program
• Intervention / Treatment: Other: Shared decision making for LDCT (3 potential outcomes LDCT on discharge, scheduled date of LDCT, or Lung Cancer Screening referral); Behavioral: Inpatient Tobacco Cessation Counseling (Handouts, NYC Quits number, Medication Recommendations to primary team, Smoking cessation referral)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natoushka Trenard, MD, MPH; Phone Number: 9548025735; Email: trenardn@nychhc.org
• Study Contact Backup: Name: Hyewon Shin, NP; Phone Number: 7186147558; Email: Hyewon.Shin@nychhc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 11362
      • Recruiting
      • Metropolitan Hospital/ NYCHHC
      • Contact: Natoushka Trenard, MD, MPH; Phone Number: 9548025735; Email: trenardn@nychhc.org
      • Contact: Hyewon Shin, NP; Email: Hyewon.Shin@nychhc.org
      • Contact: Natoushka Trenard, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 50-80 years of age
• greater than or equal to 20 pack year history
• currently smoking or have quit within the last 15 years

Exclusion Criteria:

• < 50 years of age, > 80 years of age
• < 20 pack year history
• quit smoking greater than 15 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meets LCS criteria and former smoker; LDCT on discharge, scheduled date of LDCT, or Lung cancer screening referral	Other: Shared decision making for LDCT (3 potential outcomes LDCT on discharge, scheduled date of LDCT, or Lung Cancer Screening referral); These interventions will be facilitated as an inpatient
Experimental: Meets LCS criteria and active smoker; Inpatient LCS SDM (potential outcomes: 1- LDCT on discharge, 2-scheduled date of LDCT, 3-LCS referral. Along with Inpatient Tobacco Cessation/Reduction Counseling (Handouts, NYC Quits number, medication recommendations to primary team).	Other: Shared decision making for LDCT (3 potential outcomes LDCT on discharge, scheduled date of LDCT, or Lung Cancer Screening referral); These interventions will be facilitated as an inpatient; Behavioral: Inpatient Tobacco Cessation Counseling (Handouts, NYC Quits number, Medication Recommendations to primary team, Smoking cessation referral); Active smokers only will received inpatient tobacco cessation counseling/risk reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
up-to-date status on LCS at 3 months of hospital discharge	Up-to-date status is defined as the completion of a low-dose chest CT within 15 months. Estimating equations will also be used to determine the independent association of the intervention with increase in prevalence of up-to-date LCS adjusted for patient demographic features and underlying time-trends.	3 months post hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in referrals for LCS and completion of smoking cessation/LCS eligibility data	Differences in proportions will be used to compare the prevalence of up-to-date LCS between pre and post period.	6 months

Collaborators and Investigators

• Sponsor: Physician Affiliate Group of New York
• Collaborators: Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): September 10, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 23-02-006-182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be collected and de-identified for analysis. Only analysis of de-identified data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No