Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,700
- 试验地点
- 1
- 主要终点
- Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals
研究概览
简要总结
The HEALTH Registry is a prospective, observational, non-interventional registry study of patients receiving home parenteral nutrition therapy in the US for a variety of indications.
详细描述
The objective of the HEALTH Patient Registry is to establish and track therapy utilization and outcomes of patients receiving home parenteral nutrition therapy. Data collected will include information on patient safety, clinical outcomes, resource utilization and health-related quality of life (QOL). The goals of this Registry include:
- To better understand the patients and populations requiring HPN in the U.S.
- To measure clinical outcomes associated with HPN
- To identify areas for focused quality improvement interventions
- To provide opportunity for resource allocation identification and improvement
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of any age, gender, and indication referred to Coram/CVS Specialty Infusion Services to receive HPN in an alternate site of care, such as the home or infusion suite
- •Patient must be managed by Coram/CVS Specialty Infusion Services
- •The patient or the patient's caregiver must be willing to receive care and comply with the teaching and training necessary to administer treatment
排除标准
- •Patient is unable to start, or stops receiving HPN
- •Patient is NOT managed by Coram/CVS Specialty Infusion Services
- •A patient and/or a patient's insurance will not cover cost of HPN therapy with Coram/CVS, or a patient elects not to start treatment
结局指标
主要结局
Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals
时间窗: through study completion, an average of 3 years
The therapy goals (i.e. weight gain, weight loss, weight maintenance, resolution of GI issue, etc). will be recorded at study start. Percentage of patients reaching their designated therapy goal will be recorded (presented as a single percentage of patients that successful reached any therapy goal)
Change in Quality of Life over time: The Short Form (36)
时间窗: At baseline and every 6 months during therapy through study completion, up to 3 years
To examine the effect of HPN support on quality of life (functional health and well-being) as measured by The Short Form (36) Health Survey (SF-36v2). Physical component summary (PCS) and mental component summary (MCS) scores on a scale of 0 to 100 with higher scores reflecting better outcomes will be utilized.
次要结局
- Mortality rate(through study completion, an average of 3 years)
- Catheter-related infections(through study completion, an average of 3 years)
- Number of hospital readmissions and ER visits(through study completion, an average of 3 years)