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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-70
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Visit-based IT reminders to patients and practitioners

    Other intervention

    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 intervention

    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.

Treatment groups

7,500 Participants
are divided into 3 treatment groups
Group A: Arm 1: Standard CareNo intervention 0 interventions
Group B: Arm 2: Visit Based ReminderActive comparator 1 intervention
Group C: Arm 3: Population Health OutreachActive comparator 2 interventions

Trial outcomes

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

Time frame
120 days

Secondary outcomes

1

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.

Time frame
240 days

Other outcomes

Sponsors and contacts

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