The Value of Aritficial Diet and Complex Care in Home Nutrition
Home Enteral Nutrition (HEN) Reduces Complications, Length of Stay and Health-care Costs: Results From the Multicenter Study.
1 other identifier
observational
456
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 19, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedApril 24, 2014
April 1, 2014
5.9 years
April 19, 2014
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of complications
24 moths
Secondary Outcomes (1)
Number of hospital admissions
24 months
Other Outcomes (1)
length of hospital stay
24 months
Study Arms (1)
Before HEN
Patients with tube feeding with kitchen diet for at least twelve months
Interventions
Eligibility Criteria
456 patients during home tube feeding
You may qualify if:
- 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.
You may not qualify if:
- doubtful indications for HEN, no access or an incomplete medical record,
- treatment period shorter than 12 months either before or after enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanley Dudrick's Memorial Hospital
Skawina, Malopolska, 32-050, Poland
Related Publications (2)
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.
PMID: 23528323BACKGROUNDKlek 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.
PMID: 24965306DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Stanislaw Klek, MD PhD
Stanley Dudrick's Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Departement
Study Record Dates
First Submitted
April 19, 2014
First Posted
April 24, 2014
Study Start
January 1, 2007
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
April 24, 2014
Record last verified: 2014-04