Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk

The goal of this observational study is to evaluate the treatment effect and health economic impact of oral nutritional supplements(ONS) in hospitalized patients with nutritional risk. The main questions it aims to answer are:

• To evaluate the effect of ONS on clinical outcomes in hospitalized patients with high nutritional risk
• To evaluate the health economic impact of ONS in hospitalized patients with high nutritional risk Data was collected from patients admitted to peking union medical college hospital between January 1, 2018 and December 31, 2020.

The inclusion criteria were as follows: (1) age≥18 years old; (2)length of hospital stay≥3days; (3) Only ONS was used as enteral nutrition or no enteral nutrition was received.

Exclusion criteria were: (1) age<18; (2) length of hospital stay<3 days; (3) the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions; (5) the patients who transferred from other hospitals; (6) pregnancy or lactation

We collected the following data through the hospital big data query and analysis system:

1. Basic information: gender, age, height, weight, medical insurance, etc.
2. Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment；
3. Disease Information: admission diagnosis, disease coding at admission, the first discharge diagnosis, the coding of first discharge diagnosis, the second discharge diagnosis, the third discharge diagnosis, outcome (recovery, improvement, not cured, death, transfer to another hospital)
4. Operation information: surgical name, surgery code,
5. oral nutritional supplement: drug names, unit price
6. laboratory examination: hemoglobin, albumin, prealbumin
7. hospitalization costs: total cost, self-pay cost, other cost, the type of medical insurance； Researchers will compare ONS group to see the clinical outcomes and health economic impact.

Study Overview

• Status: Not yet recruiting
• Conditions: Malnutrition; Nutritional Risk
• Intervention / Treatment: Drug: oral nutritional supplements

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Yu Wang; Phone Number: +86 18382008790; Email: med_wangyu@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
      • Contact: Yu Wang; Phone Number: +86 18382008790; Email: med_wangyu@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

hospitalized patients with nutritional risk

Description

Inclusion Criteria:

1. age≥18 years old;
2. length of hospital stay ≥3days;
3. Only ONS was used as enteral nutrition or no enteral nutrition was received.

Exclusion Criteria:

1. age<18;
2. length of hospital stay<3 days;
3. the patients who received enteral nutrition other than ONS (such as tube feeding); (4) emergency admissions;

(5) the patients who transferred from other hospitals; (6) pregnancy or lactation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
oral nutritional supplement group; Only oral nutritional supplement was used as enteral nutrition, including but not limited to Ensure®, Nutrison® and etc.	Drug: oral nutritional supplements; Only ONS was used as enteral nutrition
no-oral nutritional supplement group; no enteral nutrition was received

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total cost	The total cost of hospitalization for the patient	through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	the number of deaths during the hospital stay	through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 7, 2023
• Primary Completion (Estimated): November 7, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: CAJJ-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No