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The Value of Aritficial Diet and Complex Care in Home Nutrition

Completed
Conditions
Dietary Modification
Interventions
Dietary Supplement: HEN
Registration Number
NCT02122120
Lead Sponsor
Stanley Dudrick's Memorial Hospital
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
456
Inclusion Criteria
  • indications for home tube feeding (HTF),
  • complete present and past medical history,
  • tube feeding for at least twelve months before HEN and at least twelve months afterwards.
Exclusion Criteria
  • doubtful indications for HEN, no access or an incomplete medical record,
  • treatment period shorter than 12 months either before or after enrolment

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Before HENHENPatients with tube feeding with kitchen diet for at least twelve months
Primary Outcome Measures
NameTimeMethod
Number of complications24 moths
Secondary Outcome Measures
NameTimeMethod
Number of hospital admissions24 months

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital

🇵🇱

Skawina, Malopolska, Poland

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