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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06062914
Collaborator
(none)
30,000
1
1.4
21741.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral nutritional supplements

Study Design

Study Type:
Observational
Anticipated Enrollment :
30000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Health Economic Research on Oral Nutritional Supplements for Hospitalized Patients With Nutritional Risk
Anticipated Study Start Date :
Sep 19, 2023
Anticipated Primary Completion Date :
Oct 19, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. total cost [through study completion, an average of 1 month]

    The total cost of hospitalization for the patient

Secondary Outcome Measures

  1. mortality [through study completion, an average of 1 month]

    the number of deaths during the hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT06062914
Other Study ID Numbers:
  • CAJJ-003
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 2, 2023