Breast Cancer Outreach Among Primary Care Patients

This project aims to evaluate different approaches to increase breast cancer screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, the investigators will evaluate different approaches to increase completion of screening among eligible patients, including ordering mammograms in bulk prior to outreach, sending personalized text reminders, and endorsing of the communication by the primary care provider.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: No Bulk Order; Behavioral: Texting; Behavioral: Bulk Order; Behavioral: Clinician Endorsement; Behavioral: Standard Endorsement

Detailed Description

While mammograms are recommended by guidelines for early detection of breast cancer, mammogram rates are significantly lower now than they were prior to the initial COVID-19 pandemic surge in early 2020. In this project, the investigators will evaluate different ways of reaching out to eligible patients to encourage them to participate in breast cancer screening. Through letters, texting, and the electronic health record portal (MyPennMedicine (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary care provider endorsement to traditional outreach messaging with the goal of increasing breast cancer screening uptake.

• Study Type: Interventional
• Enrollment (Actual): 24680
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women ages 40-74
2. Followed by Primary Care with a Penn Medicine PCP listed and at least one visit in the last 2 years
3. Health Maintenance due (default biannual screening starting at age 50 or edit modifier based on input by clinician)

Exclusion Criteria:

1. Currently scheduled for a mammogram
2. History of bilateral mastectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: No Order	Behavioral: No Bulk Order; The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.
EXPERIMENTAL: No Order + Text (NO+T)	Behavioral: No Bulk Order; The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.; Behavioral: Texting; In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.
EXPERIMENTAL: Bulk Order (BO)	Behavioral: Bulk Order; A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.
EXPERIMENTAL: Bulk Order + Text (BO+T)	Behavioral: Texting; In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.; Behavioral: Bulk Order; A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.
EXPERIMENTAL: Clinician Endorsement (CE)	Behavioral: Clinician Endorsement; Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.
EXPERIMENTAL: Clinician Endorsement + Text (CE+T)	Behavioral: Texting; In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.; Behavioral: Clinician Endorsement; Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.
EXPERIMENTAL: Standard Messaging (SM)	Behavioral: Standard Endorsement; Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.
EXPERIMENTAL: Standard Messaging (SM+T)	Behavioral: Texting; In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.; Behavioral: Standard Endorsement; Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mammogram Completion in 3 months	Percent of patients that complete a mammogram	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mammogram Completion in 6 months	Percent of patients that complete a mammogram	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mammogram Positivity Rate	Percent of mammograms that have positive results	3 months
Mammogram Completion by Age Groups	Percent of patients that complete a mammogram by age groups	3 months
Mammogram Completion by Race/Ethnicity	Percent of patients that complete a mammogram by race/ethnicity	3 months
Mammogram Completion by Insurance Type	Percent of patients that complete a mammogram by insurance type	3 months
Mammogram Completion by Median Household Income by Zip Code	Percent of patients that complete a mammogram by Median Household Income by zip code	3 months
Positive Mammograms Resulting in Subsequent Care	Percent of patients with a positive mammogram that receive subsequent care	3 months
Mammogram Completion by Electronic Patient Portal Status	Percent of patients that complete a mammogram by electronic patient portal status	3 months

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2021
• Primary Completion (ACTUAL): January 25, 2022
• Study Completion (ACTUAL): April 25, 2022

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): October 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Mammography; Population Health; Preventive Screening
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UPCC 15121; 849863 (OTHER: UPenn IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No