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

NCT ID: NCT00462891

Last Updated: 2013-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6730 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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IT System

IT system to send reminder letters to patients overdue for breast cancer screening.

Group Type EXPERIMENTAL

IT System

Intervention Type OTHER

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IT System

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Barry, MD

Project Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J. Barry, MD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20872083 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23286611 (View on PubMed)

Other Identifiers

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R21CA121908

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MGH-2005-P-002474/1

Identifier Type: -

Identifier Source: secondary_id

02-114

Identifier Type: -

Identifier Source: org_study_id

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