This clinical trial evaluates a multilevel care enhancement intervention called PREDICT (Personalized Risk-based Follow-up of Cervical Cancer Screening in Practice) for improving cervical cancer screening management for eligible patients in a number of primary care networks. Cervical cancer remains a public health burden, particularly for underserved populations. Cancer screening and management guidelines are moving from a "one size fits all" approach to one that is tailored to the individual. While a personalized approach may be an effective way to balance the benefits and harms of screening and management, personalized approaches require strong systems that can support the delivery of personalized care. PREDICT is a multilevel care enhancement intervention that utilizes a system-level health information technology platform to present personalized risk-based recommendations for screening, individually engages patients and their providers, and enhances team-functioning. By supporting individual patient and practitioner engagement and enhancing team coordination through a stepped care approach, PREDICT may improve cervical cancer screening management, and particularly the delivery of necessary follow-up care, for eligible patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06872346.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Jennifer S. Haas
PRIMARY OBJECTIVES:
I. To evaluate the effectiveness of the multilevel system, team and individual components of PREDICT versus (vs.) standard care by conducting a 3-arm cluster randomized controlled trial of individuals who are due for cervical cancer screening and management.
II. Guided by evaluation (Reach, Effectiveness, Adoption, Implementation, and Maintenance [RE-AIM] Qualitative Evaluation for Systematic Translation [QuEST]) and determination (Consolidated Framework for Implementation Research [CFIR]) frameworks, we will assess the reach, adoption, implementation and maintenance of PREDICT.
OUTLINE: Primary care practices are cluster randomized to 1 of 3 arms.
ARM I: Patients receive usual care.
ARM II: Patients receive usual care. Additionally, 90 days before their screening follow-up due date, patients have visit-based reminders, tailored by their risk class and including updated problem lists and health management topics, added to their patient portal/electronic health record (EHR), which can be accessed by them and their providers, to remind them of their recommended follow-up due date.
ARM III: Patients receive usual care. Additionally, 90 days before their screening follow-up due date, patients have visit-based reminders, tailored by their risk class and including updated problem lists and health management topics, added to their patient portal/EHR, which can be accessed by them and their providers, to remind them of their recommended follow-up due date. At this time, patients also receive a personalized outreach letter about their upcoming follow-up due date and may receive a second outreach via phone call 4 weeks later (60 days before due date) to remind them of their follow-up date (if scheduled) or to facilitate scheduling of a follow-up appointment. Patients in this arm who are recommended for a 3-year surveillance schedule only receive outreach via letter and do not receive outreach via phone call. Patients in this arm who are 65+ years old but have previous screening findings that warrant surveillance may receive outreach only after their practitioner is contacted.
After completion of study intervention, patients are followed up at 120 days following their follow-up due date.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJennifer S. Haas
