Clinical trial NCT02122120: The Value of Aritficial Diet and Complex Care in Home Nutrition
Official title: Home Enteral Nutrition (HEN) Reduces Complications, Length of Stay and Health-care Costs: Results From the Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Modification
Keywords: enteral nutrition, tube feeding, nutritional support
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 456
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 456 patients during home tube feeding

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of complications
timeFrame: 24 moths
Secondary outcomes:
measure: Number of hospital admissions
timeFrame: 24 months
Other outcomes:
measure: length of hospital stay
timeFrame: 24 months
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
state: Malopolska
Study officials:
affiliation: Stanley Dudrick's Memorial Hospital
name: Stanislaw Klek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Majka AJ, Wang Z, Schmitz KR, Niesen CR, Larsen RA, Kinsey GC, Murad AL, Prokop LJ, Murad MH. Care coordination to enhance management of long-term enteral tube feeding: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr. 2014 Jan;38(1):40-52. doi: 10.1177/0148607113482000. Epub 2013 Mar 25.
citation: Klek S, Hermanowicz A, Dziwiszek G, Matysiak K, Szczepanek K, Szybinski P, Galas A. Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study. Am J Clin Nutr. 2014 Aug;100(2):609-15. doi: 10.3945/ajcn.113.082842. Epub 2014 Jun 25.