Recruiting

Observational Study

Sponsor:

Albert Einstein College of Medicine

Code:

NCT06284408

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Centralized Screening Unit Implementation

Study Details

Brief summary:

This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York.

Conditions

Lung Cancer

Study ID

NCT06284408

Start date

Feb 24, 2025

Status verified date

Jan, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Clinic level:

  • a NYC RING affiliated clinic,
  • Opt into and agree to research protocol;

Patient level:

  • Age 50-77 for participants,
  • past or current smoker,
  • 20+ pack-years tobacco,
  • has quit smoking within the last 15 years,
  • without chest CT within the past 12 months, and,
  • no history of lung cancer or and at least 5 years since the diagnosis of any other malignancy

Exclusion Criteria:

Clinic level:

  • only treats pediatric patients,
  • Opt out of research protocol;

Patient level:

  • Primary care provider instruction to not contact an individual for any reason. Any individual inadvertently contacted who does not meet these criteria will be excluded from the study.

Study Design

Enrollment

9460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Centralized Screening Unit (CSU)

The CSU intervention will shift workflow by leveraging EMR data to direct automated messages to LCS-eligible patients, inviting them to connect with the CSU. The CSU incorporates evidence-based strategies for active outreach to inform patients about LCS and to offer support from lay navigators. Patients are identified through "meaningful use" of medical records data

no intervention: No Intervention Yet Started

Standard of Care during the "no intervention" period

Interventions

Centralized Screening Unit Implementation

The CSU provides a proactive and comprehensive population health approach to screening. This includes core functions of a) patient identification, b) contact, c) engagement, education and support, d) referral and navigation to LDCT screening, e) post screening follow-up, and f) retention

Primary outcome measure

  • Participant Referrals [ Time Frame: Approximately 2.5 years ]
  • Proportion of participants with early stage lung cancer (LCa) [ Time Frame: Approximately 2.5 years ]

Central Contacts and Locations

Central contacts

Locations

Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING)

Recruiting

The Bronx, New York, United States, 10467

Contacts

More Information

Sponsor

Albert Einstein College of Medicine

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • Lung Cancer Screening (LCS)
  • Low dose computed tomography (LDCT)
  • Centralized Screening Unit (CSU)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albert Einstein College of Medicine on 2026-01-23.