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

• Conditions: Patients Requiring Home Parenteral Nutrition; Malnutrition

• Registration Number: NCT04035551
• Lead Sponsor: Coram Clinical Trials

Brief Summary

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

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 Timeline

• Study Start: 2019-06-17
• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22
• Primary Completion: 2023-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals	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)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Coram CVS Specialty Infusion Services; 🇺🇸 Centennial, Colorado, United States