Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
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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 |
- 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
- 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 2015 |
| Estimated Primary Completion Date: | May 2014 (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 |
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| Contact: Nina A Bickell, MD, MPH | 212-659-9567 | nina.bickell@mssm.edu |
| 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 | |
| Principal Investigator: | Nina A Bickell, MD, MPH | Mount Sinai School of Medicine |
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: | October 26, 2012 |
| 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 May 23, 2013