Health Economic Research on Oral Nutritional Supplements... | NCT06062914

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

NCT06062914

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Oct 10, 2023Actual

Enrollment

30,000Estimated

Phase

Not provided

Conditions

Malnutrition
Nutritional Risk

Interventions

oral nutritional supplements

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2023Estimated

Primary Completion Date

Nov 7, 2023Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Sep 18, 2023

First Submission Date that Met QC Criteria

Sep 25, 2023

First Posted Date

Oct 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2023

Last Update Posted Date

Oct 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Basic information: gender, age, height, weight, medical insurance, etc.
Clinical information: admission paths, admission time, admission departments, discharge time, discharge unit, length of stay, mode of payment；
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)
Operation information: surgical name, surgery code,
oral nutritional supplement: drug names, unit price
laboratory examination: hemoglobin, albumin, prealbumin
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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
no-oral nutritional supplement group		no enteral nutrition was received

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral nutritional supplements	Drug	Only ONS was used as enteral nutrition	oral nutritional supplement group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age<18;
length of hospital stay<3 days;
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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

hospitalized patients with nutritional risk

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu Wang	Contact	+86 18382008790		med_wangyu@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital		Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided