Centralized Screening Unit (CSU) at Montefiore-Einstein

NCT06284408 | Recruiting

• 1 other identifier: 2024-15683
• Study Type: interventional
• Target: 9,460
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Participant Referrals

  The number of participant referrals by clinician for LCS by the CSU versus the number of clinician referrals will be assessed and reported.

  Approximately 2.5 years

• Proportion of participants with early stage lung cancer (LCa)

  The proportion of participants with early stage LCa disease (for the purposes of this study defined as any Stage 1 or Stage 2 LCa) amongst those who received LCS during the study period compared to those diagnosed in the general Einstein-Montefiore population during the same time period, including the 11 NYC RING clinics not in the trial, and the preceding 7 years (i.e., since LDCT has been available at MMC) will be assessed and reported.

  Approximately 2.5 years

Study Arms (2)

Centralized Screening Unit (CSU)

OTHER

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

Other: Centralized Screening Unit Implementation

No Intervention Yet Started

NO INTERVENTION

Standard of Care during the "no intervention" period

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

Centralized Screening Unit (CSU)

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• + 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

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

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• H. Dean Hosgood, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H. Dean Hosgood, PhD

CONTACT

203-215-3275; dean.hosgood@einsteinmed.edu

Yocheved Halberstam, MPH

CONTACT

917-833-1070; yocheved.halberstam@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Systems-level intervention which using a mixed study design including stepped-wedge with a cluster randomized arm within the stepped-wedge. The implementation and evaluation of the CSU will be accomplished using cluster randomization to select 24 sites to be phased-into the CSU intervention according to a stepped-wedge design. Randomization will take place at the clinic level. The clinic clusters will be brought 'online' in a graded manner over the study period. 24 of the 35 NYC RING sites will be selected to enter the experimental (CSU) condition in three waves: Month 6, Month 12, or Month 18 after the start of the study. The remaining 11 sites will receive CSU support after completion of the third randomized group of clinics

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 29, 2024
• Study Start: February 24, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)