protocolSection identificationModule nctId: NCT06284408, orgStudyIdInfo id: 2024-15683, briefTitle: Centralized Screening Unit (CSU) at Montefiore-Einstein, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Albert Einstein College of Medicine, class: OTHER, collaborators name: American Cancer Society, Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 9460, type: ESTIMATED, armsInterventionsModule interventions name: Centralized Screening Unit Implementation, outcomesModule primaryOutcomes measure: Participant Referrals, primaryOutcomes measure: Proportion of participants with early stage lung cancer (LCa), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 77 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING), city: Bronx, state: New York, zip: 10467, country: United States, contacts name: Yocheved Halberstam, MPH, role: CONTACT, phone: 917-833-1070, email: yocheved.halberstam@einsteinmed.edu, contacts name: H. Dean Hosgood, PhD, role: CONTACT, phone: 203-215-3275, email: dean.hosgood@einsteinmed.edu, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False