Increasing Screening for Cancer Using EHR-Nudges

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06177795
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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).

Detailed Description

Cancer is a leading cause of mortality in the United States. While strong USPSTF guideline recommendations support appropriate screening for early detection and to avoid preventable deaths, breast cancer screening is often underutilized. Increasing breast cancer screening rates is challenging, in part, because it requires complementary decisions from clinicians (e.g., recommend and counsel patients about screening) and patients (e.g., to internalize risks and choose to complete screening). Presently, the lack of interventions directly targeting both clinicians' and patients' decision-making may underscore the relatively stagnant screening rates in the United States. There is a significant need to develop and scale low-cost interventions that increase breast cancer screening while simultaneously addressing the needs of high-risk patients and reducing disparities. Building upon prior work, the investigators propose to develop and test EHR-based clinician and patient nudges, with an additional intensified nudge to high-risk patients, to help increase screening mammography rates.

This study consists of two complementary and concurrent, cluster-randomized, pragmatic trials to be conducted at Penn and UH.

Study Timeline

• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study Start: 2023-12-18
• Study First Posted: 2023-12-20
• Primary Completion: 2024-10-07
• Study Completion: 2025-04-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21122

Inclusion Criteria

All patients must meet the following criteria to be eligible:

1. Women between 40 and 74 years of age
2. 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)
3. Are overdue and eligible for a mammogram per Health Maintenance
4. Does not have a future scheduled mammogram appointment

For the Penn Trial patient intensification nudge, at least one of the following criteria must be met to be considered high risk and randomized to receive the intensification nudge:

1. Medicare Insurance
2. Medicaid Insurance
3. No EHR patient portal account
4. Zero log-ins to EHR patient portal in the previous year

Exclusion Criteria

Patients will be excluded from the study if:

1. History of bilateral mastectomy
2. Have a mammogram exclusion modifier in Health Maintenance
3. Have no phone number (home or mobile) listed in their chart (Penn Trial only)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients who complete a screening mammogram within 3 months after the visit	3 months	The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who complete a screening mammogram within 6 months after the visit	6 months	The secondary outcome is screening mammogram completion within 6 months after the first eligible primary care visit.

Trial Locations

Locations (2)

Case Western Reserve University/University Hospitals; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States