Centralized Screening Unit (CSU) at Montefiore-Einstein

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-77
SponsorAlbert Einstein College of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

a NYC RING affiliated clinic,

Opt into and agree to research protocol;

Age 50-77 for participants,

past or current smoker,

Disqualifiers

only treats pediatric patients,

Opt out of research protocol;

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Centralized Screening Unit Implementation

    Other intervention

    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

Treatment groups

9,460 Participants
are divided into 2 treatment groups
Group A: Centralized Screening Unit (CSU)Other 1 intervention
Group B: No Intervention Yet StartedNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Approximately 2.5 years
2

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.

Time frame
Approximately 2.5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albert Einstein College of Medicine

Lead sponsor

American Cancer Society, Inc.

Collaborator