Breast Cancer Outreach Among Primary Care Patients

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT05089903
• Collaborator: (none)
• Enrollment: 24,680
• Location: 1
• Arms: 8
• Actual Duration (Months): 6
• Patients Per Site Per Month: 4127.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Bulk Order; Behavioral: Texting; Behavioral: Clinician Endorsement; Behavioral: No Bulk Order; Behavioral: Standard Endorsement	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24680 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• Official Title: Breast Cancer Outreach Among Primary Care Patients
• Actual Study Start Date: Oct 25, 2021
• Actual Primary Completion Date: Jan 25, 2022
• Actual Study Completion Date: Apr 25, 2022

Arms and Interventions

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: 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: 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: 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: Bulk Order; A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.; 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: 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.

Outcome Measures

Primary Outcome Measures

1. Mammogram Completion in 3 months [3 months]

   Percent of patients that complete a mammogram

Secondary Outcome Measures

1. Mammogram Completion in 6 months [6 months]

   Percent of patients that complete a mammogram

Other Outcome Measures

1. Mammogram Positivity Rate [3 months]

   Percent of mammograms that have positive results

2. Mammogram Completion by Age Groups [3 months]

   Percent of patients that complete a mammogram by age groups

3. Mammogram Completion by Race/Ethnicity [3 months]

   Percent of patients that complete a mammogram by race/ethnicity

4. Mammogram Completion by Insurance Type [3 months]

   Percent of patients that complete a mammogram by insurance type

5. Mammogram Completion by Median Household Income by Zip Code [3 months]

   Percent of patients that complete a mammogram by Median Household Income by zip code

6. Positive Mammograms Resulting in Subsequent Care [3 months]

   Percent of patients with a positive mammogram that receive subsequent care

7. Mammogram Completion by Electronic Patient Portal Status [3 months]

   Percent of patients that complete a mammogram by electronic patient portal status

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 74 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Medicine	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shivan Mehta, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05089903
• Other Study ID Numbers: UPCC 15121; 849863
• First Posted: Oct 22, 2021
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shivan Mehta, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania: Mammography; Preventive Screening; Population Health
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 27, 2022