Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities

NCT ID: NCT01544374

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-05-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Tracking & Feedback

Systems based intervention tracking oncology consultations and feeding back information to surgeons

Group Type: EXPERIMENTAL

Tracking & Feedback

Intervention Type: OTHER

Systems based intervention tracking oncology consultations and feeding back information to surgeons

Control- no intervention

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tracking & Feedback

Systems based intervention tracking oncology consultations and feeding back information to surgeons

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina A Bickell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine Mount Sinai

Locations

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Brooklyn Hospital Center

Brooklyn, New York, United States

University Hospital of Brooklyn at Long Island College Hospital

Brooklyn, New York, United States

Kings County Hospital

Brooklyn, New York, United States

Lutheran Medical Center

Brooklyn, New York, United States

Elmhurst Hospital Center

Elmhurst, New York, United States

Queens Hospital Center

Jamaica, New York, United States

Metropolitan Hospital Center

New York, New York, United States

Bronx-Lebanon Hospital

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29298115 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27861833 (View on PubMed)

Other Identifiers

5R01CA149025

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 09-1155

Identifier Type: -

Identifier Source: org_study_id