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

Conditions

• Cervical Cancer Screening

Eligibility Criteria

Sex

FEMALE

Age

21 Years - 70 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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)

Key Dates

First listed

Mar 12, 2025

Start date

Jul 22, 2026

Status verified

Nov 2025

Primary completion

Jul 22, 2028

Completion

Jan 22, 2029

Study Design

Enrollment

7,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• No Intervention: Arm 1: Standard Care
  Patients will receive the usual care provided by their PCP, practice, and/or specialist.
• Active Comparator: Arm 2: Visit Based Reminder
  Visit based reminders for physicians and patients that will be seen in Epic and Patient Gateway
• Active Comparator: Arm 3: Population Health Outreach
  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.

Primary Outcome Measure

Primary effectiveness outcome [ Time Frame: 120 days ]

Central Contacts

• Jennifer S Hass, MD
  617-724-1832
  [email protected]
• Amy J Wint, MSc
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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