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临床试验/NCT02218151
NCT02218151终止不适用

Patient-Centered Medical Home Care for Hematopoietic Stem Cell Transplantation: A Randomized Phase 2 Study

Duke University2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2014年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
61
试验地点
2
主要终点
Acute Graft Versus Host Disease (aGVHD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Acute Graft Versus Host Disease (aGVHD)

时间窗: 6 months

The primary endpoint is the incidence (number of events) of grade II-IV acute GVHD at 6 months. GVHD will be evaluated daily by advanced practice providers (APPs) according to standard criteria. The investigators will compare GVHD incidence rates between treatment arms using survival type regression modeling that takes competing risks into account. They will examine cause-specific Cox proportional hazards models as well as the proportional subdistribution hazard regression model developed by Fine and Gray. While the primary treatment comparison will be unadjusted, adjustment for covariates to explore the impact of various risk factors will also be performed.

次要结局

  • Disease Free Survival (DFS)(1 year)
  • Rate of Infection(1 year)
  • Overall Survival(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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