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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving home parenteral nutrition | Includes patients receiving home parenteral nutrition for any indication. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The HEALTH Registry program will collect data representative of patients receiving total parenteral nutrition (TPN) in the homecare setting.
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| Name | Affiliation | Role |
|---|---|---|
| Mark DeLegge, MD | Coram | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coram CVS Specialty Infusion Services | Centennial | Colorado | 80112 | United States |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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 |