A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IT System
Sponsored by

About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring breast cancer
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)
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IT System
Usual Care
Arm Description
IT system to send reminder letters to patients overdue for breast cancer screening.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months
Comparison of time to mammography completion in intervention vs control groups
Clinical and nonclinical outcomes recorded by Mammography FastTrack tool
Full Information
NCT ID
NCT00462891
First Posted
April 18, 2007
Last Updated
May 18, 2013
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00462891
Brief Title
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
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6730 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IT System
Arm Type
Experimental
Arm Description
IT system to send reminder letters to patients overdue for breast cancer screening.
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
IT System
Primary Outcome Measure Information:
Title
Proportion of overdue patients completing mammography screening in intervention and control groups
Description
Proportion of overdue patients completing mammography screening in intervention and control groups over the 1-year study.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months
Time Frame
1 year
Title
Comparison of time to mammography completion in intervention vs control groups
Time Frame
1 year
Title
Clinical and nonclinical outcomes recorded by Mammography FastTrack tool
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Barry, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20872083
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.
Results Reference
result
PubMed Identifier
23286611
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.
Results Reference
derived
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A Mammography FastTrack Program in Increasing the Number of Women Undergoing Breast Cancer Screening
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