DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017