Increasing Screening for Cancer Using EHR-Nudges Replication (I-SCREEN Rep)

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Behavioral: Post-Visit Patient Text Messages; Behavioral: Pre-Visit Patient Text Message; Behavioral: Smart Data Element (SDE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06995703

R33AG068947 (U.S. NIH Grant/Contract)

UPCC 03025

Details and patient eligibility

About

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. In partnership with Penn Medicine (Penn) and Case Western Reserve University-University Hospitals (UH), two complementary, concurrent 6-month, cluster randomized, pragmatic trials were conducted from December 2023 to October 2024. This trial will now replicate those interventions at Lancaster General Health (LGH), incorporating learnings from the primary trials while also adapting to align with existing health system protocols and policies. The patient nudge interventions include pre- and post-visit text message reminders to encourage the patient to schedule their mammogram, and the clinician nudge intervention includes a Smart Data Element message in the electronic health record (EHR) reminding the care team that the patient is overdue and that patients are more likely to complete their screening if recommended and ordered by their clinician.

Full 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 at a replication site (Lancaster General Health) to help increase screening mammography rates. The analyses will compare the effectiveness of clinician and patient nudges in the overall patient population and separately among high-risk patients to inform what methods are most effective for each of these populations.

Enrollment: 7,920 estimated patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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 at Lancaster General Health
3. Are overdue and eligible for a mammogram per Epic Health Maintenance
4. Does not have a future scheduled mammogram appointment

Patients meeting at least one of the following criteria will be considered high risk for screening non-completion:

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 they:

1. Have a history of bilateral mastectomy, breast cancer, or metastatic cancer
2. Have a mammogram exclusion modifier in Health Maintenance
3. Have no phone number (home or mobile) listed in their chart

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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7,920 participants in 4 patient groups

Pre-Visit Text Message/Smart Data Element Only

Experimental group

Description:

Patients randomized to this arm will receive the pre-visit text message and Smart Data Element nudges.

Treatment:

Behavioral: Smart Data Element (SDE)

Behavioral: Pre-Visit Patient Text Message

Pre-Visit Text Message/Smart Data Element + Post-Visit Text Message

Experimental group

Description:

Patients randomized to this arm will be eligible to receive both the pre- and post-visit text messages and the Smart Data Element nudges.

Treatment:

Behavioral: Smart Data Element (SDE)

Behavioral: Pre-Visit Patient Text Message

Behavioral: Post-Visit Patient Text Messages

Post-Visit Text Message Only

Experimental group

Description:

Patients randomized to this arm will be eligible to receive the post-visit text message nudges.

Treatment:

Behavioral: Post-Visit Patient Text Messages

Standard of Care

No Intervention group

Description:

Patients randomized to the standard of care arm will receive no nudge interventions.