Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)

Conditions
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Malnutrition, Patients Requiring Home Parenteral Nutrition

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients receiving home parenteral nutrition<br>Includes patients receiving home parenteral nutrition for any indication. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life over time: The Short Form (36) | 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. | At baseline and every 6 months during therapy through study completion, up to 3 years | 
| Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals | 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) | through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related infections | Determine rate of catheter-related blood stream infections (CRBSIs) ( per 1000 catheter days) | through study completion, an average of 3 years | 
| Number of hospital readmissions and ER visits | Assess number of hospital readmissions and visits to the ER | through study completion, an average of 3 years | 
| Mortality rate | Number of study participants who expired during therapy | through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home, HPN, Homecare