Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284408
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-02-21
Brief Title:
Centralized Screening Unit CSU at Montefiore-Einstein
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Implementation of a Centralized Screening Unit at Montefiore-Einstein
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 testingcare 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 14 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 750000 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-MMCs 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 CSUs impact on LCS uptake and retention patient and provider experience and the extent of lung cancer down-staging ie 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 systems well-established primary care practice-based research network PBRN NYC RING encompasses 600000 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 Montefiores 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 9460 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 educationsupport for patients needsconcerns 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
The Bronx NY population 14 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 750000 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-MMCs 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 CSUs impact on LCS uptake and retention patient and provider experience and the extent of lung cancer down-staging ie 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 systems well-established primary care practice-based research network PBRN NYC RING encompasses 600000 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 Montefiores 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 9460 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 educationsupport for patients needsconcerns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None