Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01544374
First received: February 13, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 11 hospitals that serve large proportions of minority women with breast cancer. The investigators will randomize hospitals and aim to recruit 540 women with a new breast cancer, 270 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.


Condition Intervention
Breast Cancer
Other: Tracking & Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in intervention effect of adjuvant treatment [ Time Frame: at baseline and at one year ] [ Designated as safety issue: No ]
    We will compare at initiation and completion of adjuvant treatment on all enrolled patients to determine the intervention's effect


Secondary Outcome Measures:
  • Organizational Characteristics [ Time Frame: at 4 years ] [ Designated as safety issue: No ]
    To describe the organizational characteristics and the implementation climate of the hospitals and their relationship to the hospitals' change in rates of guideline concordant adjuvant treatment pre- and post-intervention.


Estimated Enrollment: 540
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tracking & Feedback
Systems based intervention tracking oncology consultations and feeding back information to surgeons
Other: Tracking & Feedback
Systems based intervention tracking oncology consultations and feeding back information to surgeons
No Intervention: Control- no intervention
Usual Care

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 11 hospitals that serve large proportions of minority women with breast cancer. We will randomize hospitals and will recruit 540 women with a new breast cancer, 270 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=540) to provide additional quantitative measures of implementation effectiveness.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 11 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544374

Contacts
Contact: Nina A Bickell, MD, MPH 212-659-9567 nina.bickell@mssm.edu

Locations
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07052
Contact: Lori Schleicher, MD    973-926-7230    LoSchleicher@barnabashealth.org   
Sub-Investigator: Lori Schleicher, MD         
United States, New York
Bronx-Lebanon Hospital Not yet recruiting
Bronx, New York, United States, 10457
Contact: Ajay Shah, MD    718-960-1033    ajashah@bronxleb.org   
Sub-Investigator: Ajay Shah, MD         
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10461
Contact: Leslie Montgomery, MD    718-862-8840    LMONTGOM@montefiore.org   
Sub-Investigator: Leslie Montgomery, MD         
Jacobi Medical Center Not yet recruiting
Bronx, New York, United States, 10461
Contact: Maria Castaldi, MD    718-918-3060    Maria.Castaldi@nbhn.net   
Sub-Investigator: Maria Castaldi, MD         
Brooklyn Hospital Center Not yet recruiting
Brooklyn, New York, United States, 11201
Contact: Peter J Pappas, MD    718-250-6751    pjp9003@nyp.org   
Sub-Investigator: Peter J Pappas, MD         
Kings County Hospital Not yet recruiting
Brooklyn, New York, United States, 11203
Contact: Theophilus Lewis, MD    718-245-4146    Theophilus.Lewis@nychhc.org   
Sub-Investigator: Theophilus Lewis, MD         
University Hospital of Brooklyn at Long Island College Hospital Not yet recruiting
Brooklyn, New York, United States, 11201
Contact: Melita Charles, MD    718-780-2777    Melita.Charles@downstate.edu   
Sub-Investigator: Melita Charles, MD         
Lutheran Medical Center Not yet recruiting
Brooklyn, New York, United States, 11209
Contact: Alan Sickles, MD    718-630-8890    asickles@lmcmc.com   
Sub-Investigator: Alan Sickles, MD         
Elmhurst Hospital Center Not yet recruiting
Elmhurst, New York, United States, 11373
Contact: Shalini Arora, MD    718-334-2480    Shalini.Arora@mssm.edu   
Sub-Investigator: Shalini Arora, MD         
Queens Hospital Center Not yet recruiting
Jamaica, New York, United States, 11433
Contact: Margaret Kemeny, MD    718-883-4031    kemenym@nychhc.org   
Sub-Investigator: Margaret Kemeny, MD         
Metropolitan Hospital Center Not yet recruiting
New York, New York, United States, 10029
Contact: Anitha Srinivasan, MD    212-423-7915    Anitha.Srinivasan@nychhc.org   
Sub-Investigator: Anitha Srinivasan, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Nina A Bickell, MD, MPH Icahn School of Medicine Mount Sinai
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01544374     History of Changes
Other Study ID Numbers: GCO 09-1155, 5R01CA149025
Study First Received: February 13, 2012
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
Breast Cancer
Treatment Disparities
Tracking and Feedback
Registry
Cancer Therapy Disparities
Adjuvant Treatment
Racial Disparities
Underuse of Adjuvant Treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014