Supportive Transfusion Program for Patients With Hematologic Malignancies: A Cluster Randomized Trial
Summary
This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, HEME-Hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies.
Detailed description
Lack of access to blood transfusions is a key barrier to timely hospice use for patients with blood cancers. Refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding. Transfusions palliate these symptoms and improve quality of life (QOL); yet, most hospices do not provide access to transfusions. Patients are thus faced with the agonizing choice of preserving access to vital palliative transfusions versus accessing quality home-based hospice care. Patients with blood cancers and their caregivers report that transfusions are vital for their quality of life, and that access to transfusions is a key factor in deciding whether to opt for hospice care. The study team has thus developed a new model of care (HEME-Hospice) that provides access to palliative home transfusions to patients with hematologic malignancies who are enrolled in hospice. The purpose of this study is to determine whether access to HEME-hospice versus usual care improves hospice enrollment rates, quality of life (QOL), mood, and end-of-life healthcare utilization for patients with hematologic malignancies as well as QOL and mood of their caregivers. This study is a cluster randomized trial in which hematologic oncologists will be randomly assigned to access to HEME-Hospice versus usual care. Participants in this study will have access to HEME-hospice or usual care based upon the strategy to which their hematologic oncologist has been assigned.
Arms & interventions
- BehavioralHEME-Hospice Program
A care delivery program that combines home-based transfusions with routine home hospice care. Transfusions are administered by trained transfusion nurses. Standard hospice care is provided by an interdisciplinary team of non-transfusion nurse case managers, hospice aides, social workers, and chaplains.
Outcome measures
Primary
Hospice Enrollment Rate
Establish that hospice enrollment rate is higher with access to HEME-Hospice versus usual care.
Time frame: 6 months
Length of Hospice Enrollment
Number of days from hospice enrollment to date of death or hospice disenrollment
Time frame: 6 months
Secondary
Chemotherapy Utilization in the Last 14 Days of Life
Time frame: Last 14 days of life
Hospitalization Rate
Time frame: Last 30 days of life
Intensive care unit (ICU) Admission Rate
Time frame: Last 30 days of life
Hospital Death
Time frame: Last 30 days of life
High-Intensity Healthcare Utilization expenditures in the Last 30 Days of life
Time frame: Last 30 days of life
Patient Quality of life
Time frame: 6 months
Functional Assessment of Cancer Therapy-Anemia (FACT-An) Score
Time frame: 6 months
Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) Score
Time frame: 6 months
Patient Anxiety Symptoms
Time frame: 6 months
Patient Depression Symptoms
Time frame: 6 months
Caregiver Quality of Life
Time frame: 6 months
Caregiver Anxiety Symptoms
Time frame: 6 months
Caregiver Depression Symptoms
Time frame: 6 months
Eligibility criteria
Study locations (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215