Increasing Screening for Cancer Using EHR-Nudges

NCT06177795 | Completed DMC

• 2 other identifiers: UPCC 12022R33AG068947
• Study Type: interventional
• Target: 21,120
• Locations: 1 country
• Sites: 2

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).

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

Study Arms (5)

Penn: Control

NO INTERVENTION

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

Penn: Intervention

EXPERIMENTAL

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.

Behavioral: Post-visit patient text messaging; Behavioral: Default pended order

Penn: High Risk Intensification

EXPERIMENTAL

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.

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

UH: Control

NO INTERVENTION

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

UH: Intervention

EXPERIMENTAL

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

Behavioral: Default pended order

Interventions

Post-visit patient text messaging BEHAVIORAL

Patients will be sent text message reminders 4 days and 14 days after their primary care visit. The message delivered 4-days post-visit will remind the patient that a screening mammogram was recently ordered by their doctor, that appointments have been reserved for them, and to pre-commit to scheduling. The message delivered at 14-days post-visit will remind the patient of their recent screening mammogram order and encourage them to schedule their appointment, if one has not already been scheduled.

Penn: High Risk Intensification; Penn: Intervention

Default pended order BEHAVIORAL

A default pended order for a mammogram will be pended to the patient's upcoming primary care encounter and will be visible to the provider during the visit encounter. Clinical staff will have the option of signing the order or dismissing it if they deem it inappropriate for a given patient.

Penn: High Risk Intensification; Penn: Intervention; UH: Intervention

High risk bidirectional post-visit text messaging BEHAVIORAL

High risk patients randomized to receive the high risk intensification nudge will receive a bidirectional text messaging component after their visit. This intervention will query the patient about common questions or concerns about breast cancer screening. The bi-directional text messaging intervention will provide additional educational materials based on patient response as well as information about resources to help navigate to screening.

Penn: High Risk Intensification

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 (Penn Trial) or with one of the study primary care providers (UH Trial)
• Are overdue and eligible for a mammogram per Health Maintenance
• 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:
• 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:
• History of bilateral mastectomy
• Have no phone number (home or mobile) listed in their chart (Penn Trial only)

Sponsors & Collaborators

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

Study Sites (2)

Case Western Reserve University/University Hospitals

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Policy and Medicine

Model Details: For the Penn trial, primary care clinics will be randomized 2:1 to the intervention arm or control arm using covariate-constrained randomization. Patients identified as at high-risk for non-completion of breast cancer screening will be additionally randomized 1:1 at the individual level to receive an additional intensification nudge compared with the multi-component nudge intervention alone. Penn Medicine is expected to enroll approximately 15,000 patients. For the UH trial, primary care providers will be randomized 1:1 to the intervention or control arm using covariate-constrained randomization. UH is expected to enroll approximately 6,416 patients.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 18, 2023
• Primary Completion: January 7, 2025
• Study Completion: April 7, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-05

Locations

US (2)