Clinical trial NCT00462891: A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening
Official title: Breast Cancer Screening and Follow-Up in a PBRN: The Mammography FastTrack Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-19
Enrollment: 6730
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of overdue patients completing mammography screening in intervention and control groups
timeFrame: 1 year
Secondary outcomes:
measure: Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months
timeFrame: 1 year
measure: Comparison of time to mammography completion in intervention vs control groups
timeFrame: 1 year
measure: Clinical and nonclinical outcomes recorded by Mammography FastTrack tool
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael J. Barry, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.