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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462891
• Other study ID #: 02-114
• Secondary ID: R21CA121908MGH-2
• Status: Completed
• Phase: N/A
• First received: April 18, 2007
• Last updated: May 18, 2013
• Start date: March 2007

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6730
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• IT System

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Difference in percentage of patients overdue at baseline receiving mammogram during the study period in intervention and control practices at 6 months		1 year	No
Secondary	Comparison of time to mammography completion in intervention vs control groups		1 year	No
Secondary	Clinical and nonclinical outcomes recorded by Mammography FastTrack tool		1 year	No