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

NCT06876831 | Recruiting DMC

• 1 other identifier: 23-02-006-182
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer Screening Program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• difference in referrals for LCS and completion of smoking cessation/LCS eligibility data

  6 months

Study Arms (2)

Meets LCS criteria and former smoker

EXPERIMENTAL

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)

Meets LCS criteria and active smoker

EXPERIMENTAL

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); Behavioral: Inpatient Tobacco Cessation Counseling (Handouts, NYC Quits number, Medication Recommendations to primary team, Smoking cessation referral)

Interventions

Shared decision making for LDCT (3 potential outcomes LDCT on discharge, scheduled date of LDCT, or Lung Cancer Screening referral) OTHER

These interventions will be facilitated as an inpatient

Meets LCS criteria and active smoker; Meets LCS criteria and former smoker

Inpatient Tobacco Cessation Counseling (Handouts, NYC Quits number, Medication Recommendations to primary team, Smoking cessation referral) BEHAVIORAL

Active smokers only will received inpatient tobacco cessation counseling/risk reduction

Meets LCS criteria and active smoker

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Physician Affiliate Group of New York: lead
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

Metropolitan Hospital/ NYCHHC

New York, New York, 11362, United States

RECRUITING

Central Study Contacts

Natoushka Trenard, MD, MPH

CONTACT

9548025735; trenardn@nychhc.org

Hyewon Shin, NP

CONTACT

7186147558; Hyewon.Shin@nychhc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, MD MPH

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: March 10, 2025
• Primary Completion: September 10, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)