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

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Default pended order; Behavioral: Post-visit patient text messaging; Behavioral: High risk bidirectional post-visit text messaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06177795

R33AG068947 (U.S. NIH Grant/Contract)

UPCC 12022

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, 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).

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, 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.

Enrollment: 21,120 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 (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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21,120 participants in 5 patient groups

Penn: Control

No Intervention group

Description:

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

Penn: Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Post-visit patient text messaging

Behavioral: Default pended order

Penn: High Risk Intensification

Experimental group

Description:

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.

Treatment:

Behavioral: High risk bidirectional post-visit text messaging

Behavioral: Post-visit patient text messaging

Behavioral: Default pended order

UH: Control

No Intervention group

Description:

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

UH: Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Default pended order