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

Coram Clinical Trials

Status: Active, not recruiting

Conditions: Malnutrition; Patients Requiring Home Parenteral Nutrition

Study type: Observational

Funder types: Other

Identifiers

NCT04035551

CT-10-06

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,700 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,700 participants in 1 patient group

patients receiving home parenteral nutrition

Description:

Includes patients receiving home parenteral nutrition for any indication.