About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Visit-based IT reminders to patients and practitioners
Other interventionTo 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 interventionPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Secondary effectiveness outcome
The secondary effectiveness outcome, number of days to completion over a 240 day follow-up period, to examine whether follow-up occurs as quickly as possible with censoring at the end of study period for patients who never receive follow-up.
Sponsors and contacts
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