EHR-Nudges for Breast Cancer Screening

(I-SCREEN Trial)

Recruiting at 1 trial location

Overseen By Amol Navathe, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Bilateral mastectomy, No phone number, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

21122 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study, personalized nudges to clinicians and patients will be evaluated to help increase breast cancer screening rates in accordance with USPSTF guidelines among women with a primary care visit, with a particular emphasis on those at high risk for non-completion of cancer screening. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent, 6-month, cluster-randomized, pragmatic trials will be conducted. Those assigned to the intervention arm will receive the following clinician and patient level nudge interventions: clinicians will receive a default pended order for a mammogram in the visit encounter in the EHR (Penn and UH), and patients will receive post-visit text message reminders to encourage them to schedule their mammogram (Penn). Patients identified as high risk for noncompletion will be individually randomized to receive an additional bidirectional text message nudge or the standard text messaging (Penn).

Research Team

Amol Navathe, MD, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for women aged 40-74 who are overdue for a mammogram, have an upcoming primary care visit but no future mammogram scheduled. High-risk patients include those with Medicare or Medicaid, or limited use of the EHR patient portal. Women with bilateral mastectomy or without a phone number listed in their chart cannot participate.

Inclusion Criteria

A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices (Penn Trial) or with one of the study primary care providers (UH Trial)

Are overdue and eligible for a mammogram per Health Maintenance

Does not have a future scheduled mammogram appointment

Exclusion Criteria

Have a mammogram exclusion modifier in Health Maintenance

I have had both of my breasts removed.

Have no phone number (home or mobile) listed in their chart (Penn Trial only)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians receive default pended orders for mammograms and patients receive post-visit text message reminders to encourage scheduling mammograms.

6 months

Ongoing visits as per primary care schedule

High Risk Intensification

High-risk patients receive an additional bidirectional texting component to encourage mammogram completion.

6 months

Follow-up

Participants are monitored for mammogram completion within 3 to 6 months after the first eligible primary care visit.

6 months

Treatment Details

Interventions

• Default pended order
• High risk bidirectional post-visit text messaging
• Post-visit patient text messaging

Trial Overview The study tests if electronic health record (EHR) prompts and text message reminders can increase breast cancer screening rates. Clinicians get default orders to recommend mammograms, while patients receive texts reminding them to schedule one. High-risk individuals may also get extra bidirectional messaging.

Participant Groups

Group I: UH: Intervention Experimental Treatment 1 Intervention

Primary care providers randomized to the intervention arm will receive default pended orders for a mammogram.

Group II: Penn: Intervention Experimental Treatment 2 Interventions

Clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be post-visit text message reminders (standard messaging content). Clinician nudges will be default pended orders.

Group III: Penn: High Risk Intensification Experimental Treatment 3 Interventions

Patients in the intervention clinics identified as high risk for noncompletion of mammogram will be randomized 1:1 to receive the high risk intensification arm or remain in the standard intervention arm. Patients in the high risk intensification arm will receive an additional bidirectional texting component.

Group IV: UH: Control Active Control 1 Intervention

Primary care providers randomized to the control arm will receive standard of care.

Group V: Penn: Control Active Control 1 Intervention

Clinics randomized to the control arm will receive standard of care.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+