Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-11 @ 5:25 PM
Study NCT ID:
NCT02122120
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2014-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Aritficial Diet and Complex Care in Home Nutrition
Sponsor:
Stanley Dudrick's Memorial Hospital
Organization:
Study Overview
Official Title:
Home Enteral Nutrition (HEN) Reduces Complications, Length of Stay and Health-care Costs: Results From the Multicenter Study.
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.
Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.
Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.
Detailed Description:
Background: Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.
Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.
Design: The observational multicentre study in the group of 456 HEN patients was performed between January 2007 and July 2013. Two twelve-month periods were compared. During the first one patients were tube fed with home-made diet without monitoring, while during the other the complex HEN was carried out. The latter included tube feeding and complex monitoring by nutrition support team. Number of complications, hospital admissions, length of hospital stay (LOS), biochemical and anthropometric parameters and costs of hospitalization were compared.
Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.
Design: The observational multicentre study in the group of 456 HEN patients was performed between January 2007 and July 2013. Two twelve-month periods were compared. During the first one patients were tube fed with home-made diet without monitoring, while during the other the complex HEN was carried out. The latter included tube feeding and complex monitoring by nutrition support team. Number of complications, hospital admissions, length of hospital stay (LOS), biochemical and anthropometric parameters and costs of hospitalization were compared.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: