A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening

Breast Cancer Screening and Follow-Up in a PBRN: The Mammography FastTrack Trial

RATIONALE: Screening may help doctors find breast cancer cells early and plan better treatment for breast cancer. The Mammography FastTrack program may be effective in increasing the number of patients who undergo mammography.

PURPOSE: This randomized clinical trial is studying the use of a Mammography FastTrack program to increase the number of women who undergo mammography.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: IT System

Detailed Description

OBJECTIVES:

• Classify all patients within the Massachusetts General Primary Care-Practice Based Research Network (MGPC-PBRN) according to patient-primary care provider (PCP) linkage status.
• Develop a breast cancer screening intervention program called Mammography FastTrack that facilitates the ordering of mammograms to be used either by PCPs (for PCP-linked patients) or by practice managers (for practice-linked patients).
• Compare the impact of the Mammography FastTrack program on mammography screening rates in PCP-linked vs practice-linked patients overdue for breast cancer screening.

OUTLINE: This is a randomized, multicenter study.

Mammography-eligible women are linked to either a provider or a practice within the Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN). Practices within the MGPC-PBRN are stratified according to baseline mammography screening rates (high vs low) and practice type (community health center vs hospital-based vs community-based) and are randomized to 1 of 2 arms.

• Arm I: Physicians and practice managers receive e-mail alerts at months 1 and 3 informing them of the availability of mammography screening data for their panel of primary-care patients. A hyperlink refers the provider to a web-portal for the Mammography FastTrack program that lists all eligible patients who have not undergone mammography. The provider may then click a button to schedule, defer (providing reason for deferral), or provide the date of a recent mammogram.
• Arm II: Practices continue standard care. At the end of 12 months, electronic report and billing data and a review of electronic health records are used to determine the completion of mammograms.

PROJECTED ACCRUAL: A total of 6,730 patients will be accrued for this study.

• Study Type: Interventional
• Enrollment (Actual): 6730
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

DISEASE CHARACTERISTICS:

• Any outpatient at a participating Massachusetts General Primary Care Practice-Based Research Network (MGPC-PBRN) practice within the past 3 years

  • No patient who the Massachusetts General Hospital system lists as having a primary care provider who is not in one of the MGPC-PBRN networks (linking patients with a provider or practice)
  • No patient who is not linked to specific provider or practice (randomized portion of study)
• Billing, scheduling, and clinical electronic data sources required
• No mammogram within the past 2 years (randomized portion of study)
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Age 42 to 69 years (randomized portion of study)
• Female
• Menopausal status not specified

PRIOR CONCURRENT THERAPY:

• No prior bilateral mastectomy (randomized portion of study)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: IT System; IT system to send reminder letters to patients overdue for breast cancer screening.	Other: IT System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of overdue patients completing mammography screening in intervention and control groups	Proportion of overdue patients completing mammography screening in intervention and control groups over the 1-year study.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months	1 year
Comparison of time to mammography completion in intervention vs control groups	1 year
Clinical and nonclinical outcomes recorded by Mammography FastTrack tool	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Michael J. Barry, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Atlas SJ, Grant RW, Lester WT, Ashburner JM, Chang Y, Barry MJ, Chueh HC. A cluster-randomized trial of a primary care informatics-based system for breast cancer screening. J Gen Intern Med. 2011 Feb;26(2):154-61. doi: 10.1007/s11606-010-1500-0. Epub 2010 Sep 15.
• Atlas SJ, Ashburner JM, Chang Y, Lester WT, Barry MJ, Grant RW. Population-based breast cancer screening in a primary care network. Am J Manag Care. 2012 Dec;18(12):821-9.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: April 18, 2007
• First Submitted That Met QC Criteria: April 18, 2007
• First Posted (Estimate): April 19, 2007

Study Record Updates

• Last Update Posted (Estimate): May 21, 2013
• Last Update Submitted That Met QC Criteria: May 18, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 02-114; R21CA121908 (U.S. NIH Grant/Contract); MGH-2005-P-002474/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No