Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02218151 |
| Other study ID # |
Pro00051024 |
| Secondary ID |
R01CA203950-03 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 3, 2014 |
| Est. completion date |
February 14, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hematopoietic stem cell transplantation (HCT) has the potential to cure a variety of
malignant and non-malignant diseases. However, it is associated with significant morbidity,
and treatment-related mortality. This is due in large part to the prolonged pancytopenia and
immunosuppression associated with the preparatory regimen of chemotherapy and/or radiation
and the wait until engraftment of the transplanted hematopoietic stem cells. During this
vulnerable period, infectious complications are common. Historically HCT patients were kept
in protected environments to safeguard their health during the pancytopenic phase; despite
these measures, infectious complications and graft versus host disease (GVHD) remained common
and lead to significant morbidity and mortality after HCT. Currently patients are still
closely watched in the inpatient or day hospital environment, though recent practices allow
patients more freedom. This study randomizes eligible patients to receive post-transplant
care at home vs. in the hospital or clinic, per standard of care. The primary objective is to
compare the incidence of grade II-IV acute GVHD at 6 months in patients receiving
patient-centered medical home (PCMH) vs standard care.
Description:
The patient-centered medical home (PCMH) is an exciting strategy that has the potential to
revolutionize hematopoietic stem cell transplantation (HCT). Traditionally, home care has
been used for palliative care in end-stage cancer patients and in geriatrics. More recently
the PCMH has gained increasing adoption for both primary care and care of medically complex
patients. The core of the PCMH lies in the interaction between the healthcare team, the
patient's family and support, and above all, the patient. These interactions can be enhanced
through health information technologies such as the electronic health record (EHR) and
videoconferencing via iPads. In addition, collection of patient reported outcomes (PRO) will
allow feedback and adjustments.
This integration is especially important when considering the multiple complicated needs of
the HCT patient: navigating a Byzantine healthcare system that often requires input and
coordination from multiple specialists including transplanters, hematologists, infectious
disease physicians, gastroenterologists, psychiatrists, nutritionists, pharmacists, social
workers, financial coordinators, etc.; managing medication regimens to prevent infections,
GVHD, and other complications (not to mention avoiding drug and food interactions); adjusting
to multiple side effects including fatigue, weakness, anorexia, nausea, vomiting, diarrhea,
rashes, pain, anxiety, stress, organ failure, etc.; the sheer amount of time required for
healthcare visits, lab draws, waiting for results, infusions, transfusions, etc.; physical
and psychosocial struggles of living with a life-threatening disease; and the burdens of a
treatment that often seems as debilitating as the disease. The PCMH provides
patient-centered, comprehensive, accessible, and coordinated care and a systems-based
approach to quality and safety: these attributes are essential to the successful care of the
complicated HCT patient. this approach has the potential to lower overall costs while
preserving or increasing the quality of care.
