Clinical trial NCT04035551: Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry
Official title: Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home (HEALTH)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Patients Requiring Home Parenteral Nutrition
Keywords: Home
HPN
Homecare
Lead sponsor: Coram Clinical Trials
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 1700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The HEALTH Registry program will collect data representative of patients receiving total parenteral nutrition (TPN) in the homecare setting.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life over time: The Short Form (36)
timeFrame: At baseline and every 6 months during therapy through study completion, up to 3 years
measure: Efficacy of Home Parenteral Nutrition defined as the percentage of patients reaching their PN therapy goals
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Catheter-related infections
timeFrame: through study completion, an average of 3 years
measure: Number of hospital readmissions and ER visits
timeFrame: through study completion, an average of 3 years
measure: Mortality rate
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Centennial
country: United States
facility: Coram CVS Specialty Infusion Services
state: Colorado
Study officials:
affiliation: Coram
name: Mark DeLegge, MD
role: PRINCIPAL_INVESTIGATOR
References: