Preimplementation baseline comparator data collection for the “AML Care at Home” study

Mentor Name: Alix Seif
All pediatric patients with newly diagnosed acute myeloid leukemia (AML) receive multiple courses of intensive myelosuppressive chemotherapy. Each course is followed by prolonged severe neutropenia during which patients are at high risk for infection, a major cause of therapy-associated morbidity and mortality. Children’s Oncology Group (COG) supportive care guidelines recommend hospitalization for the duration of neutropenia (roughly ~35-45 days) in each of 4-5 treatment courses. Over 70% of treating institutions follow these guidelines. However, there are limited data to support this approach. Our group conducted a mixed methods research study funded by the Patient-Centered Outcomes Research Institute (PCORI) of over 550 newly diagnosed pediatric AML patients from 17 US institutions showing outpatient neutropenia management had similar bacteremia and treatment-related mortality rates and time to subsequent treatment courses compared with in-hospital management. Patient health-related quality of life and parental overall and financial distress during treatment were similar for the two management strategies. We combined our PCORI results with published adult outpatient management recommendations to develop a toolkit to identify optimal discharge candidates and guide their care. This “AML Care at Home” toolkit has now been implemented at the Children’s Hospital of Philadelphia (CHOP), with excellent implementation and clinical outcomes aligned with our PCORI comparative effectiveness data. Median total inpatient days for courses in which patients were discharge-eligible and managed as outpatients (8 days, range 4 —28) were appreciably fewer than discharge-ineligible patients who recovered inpatient (26 days, 21 — 25) or when AML Care at Home was not used as intended (31 days, 14 — 51). Course-level events were proportionally fewer among AML Care at Home early discharge courses than among either AML Care at Home inpatient courses or courses in which the toolkit was not used as intended. Bloodstream and respiratory infections were similar across groups, and Clostridium difficile infections did not occur in any early discharge courses, in contrast to inpatient-only courses. This evidence-based toolkit can identify and support the care of patients who may safely recover from AML chemotherapy as outpatients, saving a median 18 — 23 inpatient days per course. In preparation for a multi-institutional pragmatic clinical trial of AML Care at Home implementation, we will capture updated baseline data on total inpatient days, toxicity outcomes, and time to subsequent courses for patients treated at existing PCORI (now “REAL AML”) sites.