Trial Title:
Centralized Screening Unit (CSU) at Montefiore-Einstein
NCT ID:
NCT06284408
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung Cancer Screening (LCS)
Low dose computed tomography (LDCT)
Centralized Screening Unit (CSU)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Centralized Screening Unit Implementation
Description:
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
Arm group label:
Centralized Screening Unit (CSU)
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.
Detailed description:
Lung-cancer screening (LCS) reduces lung cancer mortality; however, even with known
benefits, LCS uptake has been limited. Barriers to LCS uptake include an absence of full
smoking histories in electronic medical records as well as the lack of systems-level
infrastructure to routinely identify eligible patients, to contact and navigate those
eligible, and to track and support their adherence to serial annual LDCT or follow-up
testing/care. Without infrastructure, managing these steps places significant burdens on
clinicians and their staff. Interventions to centralize and support workflows to overcome
these barriers are essential, especially at centers serving low-income communities with
an inordinate backlog of eligible patients unscreened.
The Bronx, NY (population >1.4 million) is the poorest urban county in the US, with >25%
of families living in poverty. Half of residents are Hispanic, 35% Black, and >22%
immigrants. Albert Einstein College of Medicine - Montefiore Medical Center
(Einstein-MMC) is the primary health provider for >750,000 Bronx residents. However, LCS
uptake lags and of patients who have received initial screens, half are overdue for
follow-up care or annual re-screening. Einstein-MMC's experience is typical of urban US
medical centers, reflecting the combined effects of low clinician referral and poor
patient adherence.
The Objectives of this study are to (1) Implement and study the use of a Centralized
Screening Unit (CSU), incorporating expert EMR support to help identify LCS-eligible
patients and, with clinician assistance and approval, then seek to reach out and arrange
for lung cancer screening, using lay patient navigators, as well as through patient
portal; (2) To study and implement new CSU approaches and functions, as part of an
iterative improvement program working with all stake holders; evaluate CSU's impact on
LCS uptake and retention; patient and provider experience; and the extent of lung cancer
"down-staging" (i.e., the reduction in lung cancer tumor stage at diagnosis).
This study will be based in the New York City Research Improvement and Networking Group
(NYC RING). NYC RING is the health system's well-established, primary care practice-based
research network (PBRN). NYC RING encompasses >600,000 annual patient-visits across 35
primary care sites affiliated with several different health systems serving the Bronx.
NYC RING is an Agency for Research Health and Quality (AHRQ)-recognized PBRN, fully
dedicated to a low-income urban population with the proven ability to conduct research
with busy, "real-world" clinics. The study will use cluster randomization to select sites
to be phased-into the CSU intervention according to a stepped-wedge design. When a clinic
enters the CSU condition, its LCS-eligible patients will be offered CSU services.
Enrollment and randomization will be conducted at the clinic level. In total, 24 clinics
will be randomly selected [(from the 35 within Montefiore's New York City Research and
Improvement Networking Group (NYC RING)]. Study participants will include the clinicians
at these clinics, as well as their patients who are eligible for lung cancer screening.
Over the course of the study, it is expected that 9,460 patients, within the 24 clinics,
will be eligible for screening.
The CSU intervention will shift workflow by leveraging electronic medical records (EMR)
data to direct automated messages to LCS-eligible patients, inviting them to connect with
the CSU. Lay patient navigators will [a] reach out to patients who do not respond to
automated messages, [b] collect missing smoking history data to determine eligibility,
[c] provide education/support for patients needs/concerns, [d] schedule appointments and
[e] send reminders. CSU will also track and support all steps of follow-up care. The CSU
will follow a systematic protocol to track the time and resources needed to engage and
retain different patients, including instances when the primary care clinic must get
involved with routine LCS. At the clinic level, concurrent and historical comparisons
between CSU and usual care will allow the investigator team to determine whether and how
introduction of CSU affects practice and workflows.
The Primary aim is to study the implementation of a Central Screening Unit (CSU) and its
impact on LCS patient referral in a minority, low income populations that is
underrepresented in LCS research.
There is a paucity of data regarding the effectiveness of a comprehensive CSU to improve
LCS in any community. The investigator team expects that the study will have significant
impact by providing critical data regarding methods to increase LCS using
institutional-level strategies designed to overcome entrenched systems barriers. Although
applicable to all communities, this research will specifically demonstrate the extent to
which down-staging can be achieved in historically marginalized and excluded communities
of color.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
50 Years
Maximum age:
77 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING)
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yocheved Halberstam, MPH
Phone:
917-833-1070
Email:
yocheved.halberstam@einsteinmed.edu
Contact backup:
Last name:
H. Dean Hosgood, PhD
Phone:
203-215-3275
Email:
dean.hosgood@einsteinmed.edu
Start date:
November 2024
Completion date:
March 2029
Lead sponsor:
Agency:
Albert Einstein College of Medicine
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Albert Einstein College of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06284408
