Personalized Risk-based Follow-up of Cervical Cancer Screening in Practice, RCT

NCT06872346 | Not Yet Recruiting

• 1 other identifier: 24-646
• Study Type: interventional
• Target: 7,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this PREDICT is to assess a personalize approach to screening and management of cervical cancer testing. The investigators will evaluate patients who are due for a follow up cervical cancer screening in the primary care clinics in the Massachusetts General Brigham system. Patients will be randomized by clinic into three different arms (Arm 1: standard care, Arm 2: visit based reminders, Arm 3: visit based reminders and population health outreach)

Conditions

Cervical Cancer Screening

Keywords

Cervical Cancer; Screening; Clinical Decision Support

Outcome Measures

Primary Outcomes (1)

• Primary effectiveness outcome

  The primary effectiveness outcome, measured at the patient level, is receipt of follow-up within 120 days of the due date, extracted from EHR/ associated claims documentation, for individuals with a 5-year risk of developing CIN3+ of 0.6% or more. This time interval was selected to allow patients sufficient time to move through the stepped care intervention with enough time to schedule recommended follow-up given practitioner availability

  120 days

Secondary Outcomes (1)

• Secondary effectiveness outcome

  240 days

Study Arms (3)

Arm 1: Standard Care

NO INTERVENTION

Patients will receive the usual care provided by their PCP, practice, and/or specialist.

Arm 2: Visit Based Reminder

ACTIVE COMPARATOR

Visit based reminders for physicians and patients that will be seen in Epic and Patient Gateway

Other: Visit-based IT reminders to patients and practitioners

Arm 3: Population Health Outreach

ACTIVE COMPARATOR

Visit based reminders for physicians and patients that will be seen in Epic and Patient Gateway. Patients will received outreach from a population health coordinator. Patients will be sent educational materials, a reminder letter, and if needed, additional help scheduling their follow up appointment.

Other: Visit-based IT reminders to patients and practitioners; Other: Population outreach

Interventions

Visit-based IT reminders to patients and practitioners OTHER

To identify patients due for CCSM, simplify test ordering/referral, and track follow-up, PREDICT will include: 1) automated updating of a patient's problem list with the current cervical screening finding, 2) automated updating of cervical cancer health maintenance topics to the appropriate time interval and follow-up test/ procedure through the use of modifiers, 3) "SmartSets" to standardize ordering of procedures/ specialty referrals.

Arm 2: Visit Based Reminder; Arm 3: Population Health Outreach

Population outreach OTHER

Patients will be sent a reminder letter 90 days prior to the due date via the patient portal or mailed if no portal account (Outreach 1). If needed, four weeks later a phone call from the outreach coordinator reminds patients of the follow-up date if scheduled or helps establish follow-up (Outreach 2). The coordinator could also place an order for a referral and send a reminder to the practitioner to sign it if appropriate. The coordinator will review and document any "alternative care plans" discussed by the PCP and patient.

Arm 3: Population Health Outreach

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a cervix and are 21-70 years old
• receive care at a participating primary care practice (i.e. PCP team visit within past 3 years)
• have had a Pap and/ or HPV test within the past 3.5 years
• has a CCSM result that suggest a 5-year risk of developing CIN3+ that warrants surveillance at 1 or 3 years, diagnostic colposcopy, or treatment (i.e., above average risk).

You may not qualify if:

• were diagnosed with cervical cancer/ CIN3+ prior to the most recent screening Pap or HPV test
• have had their cervix removed
• are not English or Spanish-speaking.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Jennifer S Hass, MD

CONTACT

617-724-1832; Jennifer.Haas@mgh.harvard.edu

Amy J Wint, MSc

CONTACT

awint@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control Arm (Standard Care) patients will receive the usual care provided by their PCP, practice, and/or specialist.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 12, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: March 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share