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

Coram Clinical Trials1,700 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

1,700

Conditions

Malnutrition Patients Requiring Home Parenteral Nutrition

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Coram CVS Specialty Infusion Services

Centennial, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: through study completion, an average of 3 years

Secondary Outcomes

Catheter-related infections

Determine rate of catheter-related blood stream infections (CRBSIs) ( per 1000 catheter days)

Time frame: 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

Time frame: through study completion, an average of 3 years

Mortality rate

Number of study participants who expired during therapy

Time frame: through study completion, an average of 3 years

Data from ClinicalTrials.gov

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