Clinical trial NCT02218151: Medical Home Care for Hematopoietic Stem Cell Transplantation Phase 2
Official title: Patient-Centered Medical Home Care for Hematopoietic Stem Cell Transplantation: A Randomized Phase 2 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood Disorders
Keywords: Hematopoietic
Stem Cell
Transplant
patient-centered
Microbiota
GVHD
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Scheduled to undergo a hematopoietic stem cell transplant for any cancer or non-cancer illness
2. Age 18-80 years of age
3. Karnofsky Performance Scale (KPS)\> 80
4. A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke

Exclusion Criteria:

1. Lack of a caregiver
2. Pregnant women
3. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
4. Use of homeopathic medications or probiotics that may impact gut microbiota

Primary outcomes:
measure: Acute Graft Versus Host Disease (aGVHD)
timeFrame: 6 months
Secondary outcomes:
measure: Rate of Infection
timeFrame: 1 year
measure: Disease Free Survival (DFS)
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
measure: Comparison of Gut Microbiota
timeFrame: 6 months
Locations:
city: Durham
country: United States
facility: Duke University Adult Bone Marrow Transplant Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Nelson J C, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: