Lung CancerNCT06284408
Centralized Screening Unit (CSU) at Montefiore-Einstein
A study testing Centralized Screening Unit Implementation in people with Lung Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Centralized Screening Unit Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,460 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING)
The Bronx, New York, 10467
Yocheved Halberstam, MPH, 917-833-1070, yocheved.halberstam@einsteinmed.edu
H. Dean Hosgood, PhD, 203-215-3275, dean.hosgood@einsteinmed.edu
About this study
Official title: Implementation of a Centralized Screening Unit at Montefiore-Einstein
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Centralized Screening Unit Implementation
- Keywords
- Lung Cancer Screening (LCS), Low dose computed tomography (LDCT), Centralized Screening Unit (CSU)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centralized Screening Unit ImplementationOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Centralized Screening Unit Implementation |
| No Intervention Yet Started | No intervention | Standard of Care during the "no intervention" period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start24 Feb 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 9,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- H. Dean Hosgood, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284408
- Sponsor's protocol ID
- 2024-15683
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Centralized Screening Unit at Montefiore-Einstein
- ClinicalTrials.gov ID
- NCT06284408
- Acronym / sponsor ID
- 2024-15683
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer Screening (LCS), Low dose computed tomography (LDCT), Centralized Screening Unit (CSU)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9,460 participants (estimated)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Centralized Screening Unit (CSU) | Other | Other: Centralized Screening Unit ImplementationThe 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 Yet Started | No intervention | –Standard of Care during the "no intervention" period |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- a NYC RING affiliated clinic,
- Opt into and agree to research protocol;
- Age 50-77 for participants,
- past or current smoker,
- 20+ pack-years tobacco,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centralized Screening Unit ImplementationThe 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 | Other | Centralized Screening Unit (CSU) |
Primary outcome
Participant Referrals
Time frame: Approximately 2.5 years
The number of participant referrals by clinician for LCS by the CSU versus the number of clinician referrals will be assessed and reported.
Proportion of participants with early stage lung cancer (LCa)
Time frame: Approximately 2.5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
H. Dean Hosgood, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centralized Screening Unit Implementation in people with Lung Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact H. Dean Hosgood, PhD (203-215-3275, dean.hosgood@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Referrals (time frame: Approximately 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.