The Value of Aritficial Diet and Complex Care in Home Nutrition

Completed

• Conditions: Dietary Modification

• 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-19
• Study First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Study First Posted: 2014-04-24
• Last Update Posted: 2014-04-24

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

Primary Outcome Measures

Name	Time	Method
Number of complications	24 moths

Secondary Outcome Measures

Name	Time	Method
Number of hospital admissions	24 months

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Malopolska, Poland