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

NCT ID: NCT06876831

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer Screening Program

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Meets LCS criteria and former smoker

LDCT on discharge, scheduled date of LDCT, or Lung cancer screening referral

Group Type EXPERIMENTAL

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

Intervention Type OTHER

These interventions will be facilitated as an inpatient

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).

Group Type EXPERIMENTAL

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

Intervention Type OTHER

These interventions will be facilitated as an inpatient

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

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fred Hutchinson Cancer Center

OTHER

Sponsor Role collaborator

Physician Affiliate Group of New York

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Natoushka Trenard

Attending physician, MD MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Metropolitan Hospital/ NYCHHC

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Natoushka Trenard, MD, MPH

Role: CONTACT

9548025735

Hyewon Shin, NP

Role: CONTACT

7186147558

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Natoushka Trenard, MD, MPH

Role: primary

9548025735

Hyewon Shin, NP

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-02-006-182

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LDCT-SC-FI Low-dose CT Screening for Lung Cancer
NCT05630950 ACTIVE_NOT_RECRUITING NA
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)
NCT04200534 ACTIVE_NOT_RECRUITING EARLY_PHASE1