Increasing Screening for Cancer Using EHR-Nudges Replication

NCT06995703 | Active Not Recruiting DMC

• 2 other identifiers: UPCC 03025R33AG068947
• Study Type: interventional
• Target: 8,490
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Screening; Mammogram; Behavioral Economics; Prevention

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who complete a screening mammogram within 3 months after the visit

  The primary outcome is screening mammogram completion within 3 months after the first eligible primary care visit.

  3 months

Secondary Outcomes (1)

• Proportion of patients who complete a screening mammogram within 6 months after the visit

  6 months

Other Outcomes (1)

• Difference in screening rates between high and low risk subgroups within 3 months after the visit

  3 months

Study Arms (4)

Pre-Visit Text Message/Smart Data Element Only

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Post-Visit Text Message Only

EXPERIMENTAL

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

Behavioral: Post-Visit Patient Text Messages

Standard of Care

NO INTERVENTION

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

Interventions

Smart Data Element (SDE) BEHAVIORAL

The clinician-facing Smart Data Element (SDE) in the EHR will be visible to the provider and care team during the visit encounter. The SDE will display as a section in pre-charting, check-in, and rooming and will notify the clinician and care team that a pre-visit communication was sent to the patient regarding scheduling an overdue mammogram and including results from prior work that show that patients are more likely to complete their screening if they receive an order and recommendation from their provider.

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

Pre-Visit Patient Text Message BEHAVIORAL

Patients will be sent a text message reminder 1 day prior to their scheduled primary care visit. This message will remind them of their upcoming appointment, highlight that they may be overdue for their mammogram, and encourage them to speak with their provider or schedule now by using the provided online scheduling link or phone number. Patients who do not have a cell phone number listed in the EHR will receive automated voice recording (AVR).

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

Post-Visit Patient Text Messages BEHAVIORAL

Patients will be sent text message reminders 4 days and 14 days after their completed primary care visit if they have not yet scheduled or completed their screening mammogram. The message delivered at 4 days post-visit will remind the patient to schedule and that appointments are available for them. The message delivered at 14-days post-visit will again encourage the patient to schedule their mammogram, if one has not already been scheduled or completed. Both messages will include a scheduling phone number and link to self-schedule online. Patients who do not have a cell phone number listed in the EHR will receive automated voice recording (AVR).

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

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must meet the following criteria to be eligible:
• Women between 40 and 74 years of age
• A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices at Lancaster General Health
• Are overdue and eligible for a mammogram per Epic Health Maintenance
• 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:
• Medicare Insurance
• Medicaid Insurance
• No EHR patient portal account
• Zero log-ins to EHR patient portal in the previous year

You may not qualify if:

• Patients will be excluded from the study if they:
• Have a history of bilateral mastectomy, breast cancer, or metastatic cancer
• Have no phone number (home or mobile) listed in their chart

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amol Navathe, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Policy and Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 29, 2025
• Study Start: June 2, 2025
• Primary Completion: March 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)