Clinical trial NCT03443557: Effects of Oral Nutrition Supplement in Thai Malnourished Patients
Official title: Effects of Oral Nutrition Supplement in Thai Malnourished Patients : A Cross-sectional Nutrition Day Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnourished
Hospitalized
Keywords: Oral nutrition supplement
malnutrition
mortality
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai hospitalized patients

Brief summary: A retrospective study based on Thai data from Nutrition Day study (nD). Comparing clinical outcome between malnourished patients who were prescribed oral nutrition supplement along with hospital diet and those without oral nutrition supplement.

Detailed description: Prevalence of malnutrition in hospitalized patients varies from 30-70% depend on category of patients recruited. Adverse effects of malnutrition include increase of infection complication, increase hospital length of stay, and increase mortality. Prescription of oral nutrition supplement (ONS) have been proved to provide patients more calorie and protein intake and can improve patients' outcome.

Despite the proved benefits of oral nutrition supplement(ONS), prescription of it in Thai hospitalized patients are far less than it should. The main reason of this under-practice is the limitation of health policies which considered ONS as an optional from main meals. Additional cost for ONS has to be paid by patients themselves, therefore the patients who have no willing to pay usually refuse to receive ONS. Unawareness of physician regarding its benefits is also a problem. In order to convince Thai authorities to allow for reimbursement of ONS and encourage prescription of ONS among physicians, an evidence based benefits of ONS in large Thai population is needed.

The nD study was a single-day, population-based, standardized, multinational, cross-sectional audit and was performed worldwide, includes Thailand, in hospitals, nursing homes and intensive care units performing since 2006 to present. Every year, registered hospitals survey their patients regarding nutritional status, nutritional support. A follow-up for clinical outcome are perform at 30 days after the first survey, include mortality, readmission. This study will based on data of Thai patients collected from nD study during 2006-2016.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old and above
* identified as malnourished or at risk

Exclusion Criteria:

* terminally ill patients
* receiving concomitant enteral tube feeding and/or supplemental parenteral nutrition

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Discharge rate
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Re-admission rate
timeFrame: 30 days
Other outcomes:
measure: prevalence of oral nutrition supplement prescription in Thai hospitalized patients
timeFrame: 10 years
Locations:
city: Petah Tikva
country: Israel
facility: Rabin medical center
Study officials:
affiliation: Rabin Medical Center
name: Pierre Singer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milne AC, Potter J, Vivanti A, Avenell A. Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 2009 Apr 15;2009(2):CD003288. doi: 10.1002/14651858.CD003288.pub3.
citation: Philipson TJ, Snider JT, Lakdawalla DN, Stryckman B, Goldman DP. Impact of oral nutritional supplementation on hospital outcomes. Am J Manag Care. 2013 Feb;19(2):121-8.
citation: Norman K, Kirchner H, Freudenreich M, Ockenga J, Lochs H, Pirlich M. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Clin Nutr. 2008 Feb;27(1):48-56. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.