- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01544374
Tracking & Feedback Registry to Reduce Breast Cancer Treatment Disparities
Implementing a Tracking & Feedback Registry to Allay Cancer Therapy Disparities
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New Jersey
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Newark, New Jersey, Forenede Stater, 07052
- Newark Beth Israel Medical Center
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New York
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Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center
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Bronx, New York, Forenede Stater, 10461
- Jacobi Medical Center
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Bronx, New York, Forenede Stater, 10457
- Bronx-Lebanon Hospital
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Brooklyn, New York, Forenede Stater, 11201
- Brooklyn Hospital Center
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Brooklyn, New York, Forenede Stater, 11203
- Kings County Hospital
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Brooklyn, New York, Forenede Stater, 11201
- University Hospital of Brooklyn at Long Island College Hospital
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Brooklyn, New York, Forenede Stater, 11209
- Lutheran Medical Center
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Elmhurst, New York, Forenede Stater, 11373
- Elmhurst Hospital Center
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Jamaica, New York, Forenede Stater, 11433
- Queens Hospital Center
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New York, New York, Forenede Stater, 10029
- Metropolitan Hospital Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Tracking & Feedback
Systems based intervention tracking oncology consultations and feeding back information to surgeons
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Systems based intervention tracking oncology consultations and feeding back information to surgeons
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Ingen indgriben: Control- no intervention
Usual Care
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in intervention effect of adjuvant treatment
Tidsramme: at baseline and at one year
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We will compare at initiation and completion of adjuvant treatment on all enrolled patients to determine the intervention's effect
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at baseline and at one year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Organizational Characteristics
Tidsramme: at 5 years
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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.
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at 5 years
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nina A Bickell, MD, MPH, Icahn School of Medicine Mount Sinai
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 09-1155
- 5R01CA149025 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Brystkræft
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Cairo UniversityIkke rekrutterer endnu
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The First Affiliated Hospital of Xiamen UniversityIkke rekrutterer endnuLocally Advanced Breast Cancer (LABC)
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Atlas UniversityIkke rekrutterer endnuBrystkræft | Locally Advanced Breast Cancer (LABC)Tyrkiet (Türkiye)
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ETOP IBCSG Partners FoundationAfsluttetBreast Cancer Invasive NosItalien
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Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAfsluttetBreast Cancer Invasive NosSpanien
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Second Affiliated Hospital, School of Medicine,...RekrutteringTNBC, Triple Negative Breast CancerKina
Kliniske forsøg med Tracking & Feedback
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McGill UniversityInnodem NeurosciencesRekrutteringKlinisk isoleret syndrom | Recidiverende remitterende multipel skleroseCanada
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University of MinnesotaAfsluttet
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Fondazione Policlinico Universitario Agostino Gemelli...Ikke rekrutterer endnuHjertefejl | Atrieflimren | Arytmi | Kardiomyopatier | Kardiomyopati, dilateret | Ventrikulær arytmi | Systolisk dysfunktion
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Duke UniversityAfsluttetForhøjet blodtryk | SundhedsadfærdForenede Stater
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Marco Stephan Lofrano AlvesUkendtDekompenseret hjertesvigtBrasilien
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Ahmed Mohamed Moheb El-DinIkke rekrutterer endnuPatent Ductus Arteriosus | Medfødt hjertefejl
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University Hospital, MontpellierAfsluttetMyokardiefunktion | Ekkografiske parametre opnået ved speckle tracking | BørnekræftFrankrig
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Peking University Third HospitalRekrutteringAkut myokardieinfarktKina
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Haiyan WangAfsluttet
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Assiut UniversityUkendt