Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Tracking & Feedback (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Icahn School of Medicine at Mount Sinai Official(s) and/or principal investigator(s): Nina A Bickell, MD, MPH, Principal Investigator, Affiliation: Icahn School of Medicine Mount Sinai
Overall contact: Nina A Bickell, MD, MPH, Phone: 212-659-9567, Email: nina.bickell@mssm.edu
Summary
Breast cancer is the second most common cause of cancer death in women. Black women are
less likely than white women to develop breast cancer but, they are more likely to die of
the disease. Some of this survival discrepancy is likely due to underuse of adjuvant
therapies proven to increase survival. Breast cancer treatment often requires coordination
among surgeons, pathologists, primary care physicians, medical and radiation oncologists.
In NYC, black and Hispanic women who accessed care and underwent surgical treatment of their
breast cancer were twice as likely as whites to experience underuse of adjuvant treatment.
Disturbingly, 1/3 of these underuse cases were episodes in which the surgeon recommended
treatment, the patient did not refuse and yet, care did not ensue. Underuse in such
circumstances is attributable to system failures than to specific provider or patient
factors.
In this proposed randomized controlled trial, the investigators aim to test the
effectiveness of a Tracking and Feedback (T&F) registry innovation to increase rates of
completed oncology consultation and reduce both underuse of needed adjuvant therapy and
racial disparities in receipt of these treatments. The investigators also aim to assess the
feasibility of implementing a T&F Registry in these high-risk hospitals by evaluating
implementation effectiveness for that innovation. The investigators have recruited 10
hospitals that serve large proportions of minority women with breast cancer. The
investigators will randomize hospitals and aim to recruit 354 women with a new breast
cancer, 177 per intervention arm. The investigators choose these "high risk" hospitals
because they serve predominantly minority populations, and such hospitals have higher rates
of the system failure cause of underuse, and particularly, the type of underuse targeted by
our Tracking and Feedback Registry.
Clinical Details
Official title: Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: Change in intervention effect of adjuvant treatment
Secondary outcome: Organizational Characteristics
Detailed description:
Breast cancer is the second most common cause of cancer death in women. Black women are less
likely than white women to develop breast cancer but, they are more likely to die of the
disease. Some of this survival discrepancy is likely due to underuse of adjuvant therapies
proven to increase survival. Breast cancer treatment often requires coordination among
surgeons, pathologists, primary care physicians, medical and radiation oncologists. In
NYC, black and Hispanic women who accessed care and underwent surgical treatment of their
breast cancer were twice as likely as whites to experience underuse of proven-effective
adjuvant treatment. Disturbingly, 1/3 of these underuse cases were episodes in which the
surgeon recommended treatment, the patient did not refuse and yet, care did not ensue.
Underuse in these circumstances was attributed to system failures rather than to provider or
patient factors. Such system failures occurred more often among minority women and among
women treated at hospitals serving predominantly minority patients. To target these system
failures at 6 NYC hospitals, 4 of which served predominantly minority patients, we used a
quasi-experimental pre-post test design to implement a tracking and feedback registry. The
Tracking and Feedback registry closed the referral loop between surgeons and oncologists,
increased the rate of completed oncology consultations, increased treatment rates and
eliminated the racial disparity in underuse. Its effects were greatest at the 4 hospitals
serving predominantly minority women, sites that had an EMR and patient navigation prior to
and during the T&F implementation. However, the trial was not randomized, tracking and
feedback functions were performed by study personnel and not embedded in the hospital's
workflow and details of what the surgeons did in response to the feedback was not assessed,
resulting in a call for more work in this area.
In this proposed randomized controlled trial, we will implement the Tracking and Feedback
(T&F) innovation in hospitals serving predominantly minority women. We will test the
effectiveness of the Tracking and Feedback registry innovation to increase rates of
completed oncology consultation, reduce underuse of needed adjuvant therapy and racial
disparities in receipt of these treatments. We will also assess the feasibility of
implementing a T&F Registry in these high-risk hospitals by evaluating implementation
effectiveness for this innovation. We have recruited 10 hospitals that serve large
proportions of minority women with breast cancer. We will randomize hospitals and will
recruit 354 women with a new breast cancer, 177 per intervention arm. We choose these "high
risk" hospitals because they serve predominantly minority populations, and such hospitals
have higher rates of the system failure cause of underuse, specifically, the type of
underuse targeted by our Tracking and Feedback Registry. We will: adapt existing
laptop-based Tracking & Feedback software to create a protected web-based format easily
accessible to all participating hospitals; tailor the Tracking & Feedback registry to each
of the participating hospitals' appropriate workflows including the areas of pathology,
surgery, medical and radiation oncology and tumor registry personnel in the process; and
embed the tracking and feedback tasks within existing hospital structures and personnel to
increase likelihood of sustainability beyond the grant. We will include in the web-based T&F
Registry an electronic data capture system to assess responses and actions to the tracking
information that is fed back to the surgeons. To assess the T&F Registry's effectiveness, we
will compare rates of underuse of patients treated at intervention versus control hospitals.
To assess implementation effectiveness at each hospital, we will assess process and outcomes
using qualitative and quantitative methods. Qualitatively, we will conduct pre- &
post-intervention interviews with key stakeholders to assess the implementation climate and
stakeholders' views of the Registry's utility. Quantitatively, we will measure and track
actions taken in response to the feedback information. As there is variability across
hospitals, we will also assess each hospital's treatment rates both pre- (N=540) and
post-intervention (N=354) to provide additional quantitative measures of implementation
effectiveness.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- All patients, who are English or Spanish speaking, with a new primary stage 1 or 2
and with tumors > 1 cm or < 1 cm and poorly differentiated breast cancer who have
undergone either breast conserving surgery or mastectomy at 1 of 10 participating
hospitals in the NY Metropolitan Area.
- All surgeons performing breast surgery at study participating hospitals
Exclusion Criteria:
- Patients with a poor prognosis due to end-stage organ failure or other concomitant
conditions such as those undergoing treatment for other cancers
Locations and Contacts
Nina A Bickell, MD, MPH, Phone: 212-659-9567, Email: nina.bickell@mssm.edu
Newark Beth Israel Medical Center, Newark, New Jersey 07052, United States; Recruiting Lori Schleicher, MD, Phone: 973-926-7230, Email: LoSchleicher@barnabashealth.org Lori Schleicher, MD, Sub-Investigator
Bronx-Lebanon Hospital, Bronx, New York 10457, United States; Recruiting Ajay Shah, MD, Phone: 718-960-1033, Email: ajashah@bronxleb.org Ajay Shah, MD, Sub-Investigator
Jacobi Medical Center, Bronx, New York 10461, United States; Recruiting Maria Castaldi, MD, Phone: 718-918-3060, Email: Maria.Castaldi@nbhn.net Maria Castaldi, MD, Sub-Investigator
Montefiore Medical Center, Bronx, New York 10461, United States; Recruiting Leslie Montgomery, MD, Phone: 718-862-8840, Email: LMONTGOM@montefiore.org Leslie Montgomery, MD, Sub-Investigator
Brooklyn Hospital Center, Brooklyn, New York 11201, United States; Recruiting Peter J Pappas, MD, Phone: 718-250-6751, Email: pjp9003@nyp.org Peter J Pappas, MD, Sub-Investigator
Kings County Hospital, Brooklyn, New York 11203, United States; Recruiting Theophilus Lewis, MD, Phone: 718-245-4146, Email: Theophilus.Lewis@nychhc.org Theophilus Lewis, MD, Sub-Investigator
Lutheran Medical Center, Brooklyn, New York 11209, United States; Recruiting Alan Sickles, MD, Phone: 718-630-8890, Email: asickles@lmcmc.com Alan Sickles, MD, Sub-Investigator
University Hospital of Brooklyn at Long Island College Hospital, Brooklyn, New York 11201, United States; Withdrawn
Elmhurst Hospital Center, Elmhurst, New York 11373, United States; Recruiting Shalini Arora, MD, Phone: 718-334-2480, Email: Shalini.Arora@mssm.edu Shalini Arora, MD, Sub-Investigator
Queens Hospital Center, Jamaica, New York 11433, United States; Recruiting Margaret Kemeny, MD, Phone: 718-883-4031, Email: kemenym@nychhc.org Margaret Kemeny, MD, Sub-Investigator
Metropolitan Hospital Center, New York, New York 10029, United States; Recruiting Anitha Srinivasan, MD, Phone: 212-423-7915, Email: Anitha.Srinivasan@nychhc.org Anitha Srinivasan, MD, Sub-Investigator
Additional Information
Starting date: October 2012
Last updated: December 9, 2014
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