Clinical trial NCT01544374: Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
Official title: Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Treatment Disparities
Tracking and Feedback
Registry
Cancer Therapy Disparities
Adjuvant Treatment
Racial Disparities
Underuse of Adjuvant Treatment
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-05
Enrollment: 198
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Change in intervention effect of adjuvant treatment
timeFrame: at baseline and at one year
Secondary outcomes:
measure: Organizational Characteristics
timeFrame: at 5 years
Other outcomes:
Locations:
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Hospital Center
state: New York
city: Brooklyn
country: United States
facility: University Hospital of Brooklyn at Long Island College Hospital
state: New York
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
city: Brooklyn
country: United States
facility: Lutheran Medical Center
state: New York
city: Elmhurst
country: United States
facility: Elmhurst Hospital Center
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: New York
country: United States
facility: Metropolitan Hospital Center
state: New York
Study officials:
affiliation: Icahn School of Medicine Mount Sinai
name: Nina A Bickell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bickell NA, Shah A, Castaldi M, Lewis T, Sickles A, Arora S, Clarke K, Kemeny M, Srinivasan A, Fei K, Franco R, Parides M, Pappas P, McAlearney AS. Caution Ahead: Research Challenges of a Randomized Controlled Trial Implemented to Improve Breast Cancer Treatment at Safety-Net Hospitals. J Oncol Pract. 2018 Mar;14(3):e158-e167. doi: 10.1200/JOP.2017.026534. Epub 2018 Jan 3.
citation: Bickell NA, Moss AD, Castaldi M, Shah A, Sickles A, Pappas P, Lewis T, Kemeny M, Arora S, Schleicher L, Fei K, Franco R, McAlearney AS. Organizational Factors Affect Safety-Net Hospitals' Breast Cancer Treatment Rates. Health Serv Res. 2017 Dec;52(6):2137-2155. doi: 10.1111/1475-6773.12605. Epub 2016 Nov 14.