The Value of Aritficial Diet and Complex Care in Home Nutrition

Dietary Modification Clinical Trial

Official title:

Home Enteral Nutrition (HEN) Reduces Complications, Length of Stay and Health-care Costs: Results From the Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122120
• Other study ID #: HEN1
• Status: Completed
• Phase: N/A
• First received: April 19, 2014
• Last updated: April 23, 2014
• Start date: January 2007
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Stanley Dudrick's Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• HEN
Patients with tube feeding with FSMP for at least twelve months

Locations

Country	Name	City	State
Poland	Stanley Dudrick's Memorial Hospital	Skawina	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of hospital stay		24 months	No
Primary	Number of complications		24 moths	No
Secondary	Number of hospital admissions		24 months	No