Clinical trial NCT06995703: Increasing Screening for Cancer Using EHR-Nudges Replication
Official title: Increasing Screening for Cancer Using EHR-Nudges, A Replication Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer
Keywords: Screening
Mammogram
Behavioral Economics
Prevention
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-05-29
Enrollment: 7920
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In a 2x2 factorial design, eligible patients will be randomized in a 1:1 ratio on two factors: 1) receive a pre-visit text message (patient nudge) and Smart Data Element (SDE) message in the EHR (clinician nudge) or no pre-visit text and SDE message; and 2) receive post-visit text messaging or no post-visit text messaging.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who complete a screening mammogram within 3 months after the visit
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of patients who complete a screening mammogram within 6 months after the visit
timeFrame: 6 months
Other outcomes:
measure: Difference in screening rates between high and low risk subgroups within 3 months after the visit
timeFrame: 3 months
Locations:
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Amol Navathe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: