Centralized Screening Unit (CSU) at Montefiore-Einstein

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT06284408
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 77 Years
Healthy Volunteers
Accepted

Interventions

  • Centralized Screening Unit Implementation — OTHER
    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

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
9,460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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

Primary Outcome Measure

Participant Referrals [ Time Frame: Approximately 2.5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING)The BronxNew York10467
Yocheved Halberstam, MPH
917-833-1070
H. Dean Hosgood, PhD
203-215-3275

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