A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients

NCT03679832 | Completed

• 1 other identifier: HA32
• Study Type: observational
• Target: 1,670
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes pre and post-Quality Improvement Program groups. A nutrition-focused Quality Improvement Program will be implemented to assess the health and economic outcomes in malnourished hospitalized patients.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Hospital Length of Stay

  Chart Review

  From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge)

Secondary Outcomes (1)

• Healthcare Resource Utilization

  Hospital Admission to 30-day Post Discharge

Study Arms (3)

Historical Group 1

Patients admitted at UMC between September 2015 and October 2016

Historical Group 2

Patients admitted at UMC between November 2016 and up to the beginning of the QIP

Nutrition-Focused QIP

Patients admitted at UMC that meet eligibility criteria and prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption 30-days post discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to a single-site in Vietnam meeting eligibility criteria for retrospective or prospective participation.

You may qualify if:

• Subject is at risk / malnourished, defined by an MST score ≥ 2 the first 24 hours post hospital admission
• Patients are admitted for the following diagnoses: Respiratory, Digestive Surgery, Cardiology, General Internal Medicine (including Endocrinology), and Gastrointestinal
• Patient is able to consume foods and beverages orally
• Patients with life expectancy ≥ 30 days
• Patient is literate and willing to voluntarily sign and date Informed Consent Form (ICF)

You may not qualify if:

• Subject has severe dementia or delirium and has no dedicated caregiver who could assure their compliance with QIP study requirements
• Subject has an eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures
• Subject is known to be allergic or intolerant to any ingredient found in the study products
• Subject is pregnant
• Subject is intubated, receiving tube feeding or parenteral nutrition

Sponsors & Collaborators

• Abbott Nutrition: lead
• University Medical Center, Vietnam: collaborator

Study Sites (1)

University Medical Center

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Suela Sulo, PhD,MSc

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 20, 2018
• Study Start: March 21, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

VN (1)