The ONSHUG Survey : A Quality Care Programme

January 20, 2017 updated by: Prof. Claude Pichard, University Hospital, Geneva

Oral Nutritive Supplements : Indications, Prescription and Follow-up for Hospitalized and Out-patients at Nutritional Risk or With Malnutrition. A Quality Care Programme at the Geneva University Hospital : The ONSHUG Survey

Hypothesis : At hospital discharge for home, the medical prescription of ONS according to the official criteria of SSNC and the legal regulations (completed prescription according to health's insurance and homecare delivery) dictates the compliance of the patient and the reimbursement of the ONS.

Study Overview

Status

Completed

Conditions

Detailed Description

Rationale : At hospital admission, patients with an acute or chronically impaired nutritional balance are at nutritional risk. These patients can be identified by the Nutritional Risk Score 2002 (NRS 2002). Oral Nutritive Supplements (ONS) represent the first line of nutrition intervention. ONS are frequently prescribed during the hospital stay, and should be continued or discontinued after the hospital discharge. This latter decision should be based on officials criteria, defined by the Swiss Society for Clinical Nutrition (SSNC). To allow ONS reimbursement according to the legal regulations, all required administrative actions should be completed at the time of ONS prescription until the end of the treatment.

Center : Geneva University Hospital (HUG), site of Cluse-Roseraie.

Design : Quality control prospective observational survey.

Population : Hospitalized adults patients with Oral Nutritive Supplements (ONS). Four hundred patients to be included.

Duration : Inclusion from April to December 2015 (9 months).

Hypothesis : At hospital discharge for home, the medical prescription of ONS according to the official criteria of SSNC and the legal regulations (completed prescription according to health's insurance and homecare delivery) dictates the compliance of the patient and the reimbursement of the ONS.

Aims : The primary aim is to document the existence of an ONS medical prescription during the hospitalization and at hospital discharge for home.

The secondary aims are to describe :

  • NRS 2002 score when prescribing ONS during the hospitalization, at hospital discharge for home and one month after hospital discharge for home
  • Indications for ONS prescription at hospital discharge for home according to the official criteria of SSNC
  • Type of ONS prescription at hospital discharge for home
  • Number of ONS consumed one month after hospital discharge compared to prescription at hospital discharge
  • Timing of the discontinuation of the ONS treatment
  • Reasons for stopping the ONS intake.

Methods : Included are all hospitalized adults patients with ONS prescription at the HUG. Excluded are patients with ONS delivery by a homecare before the admission at the HUG or patients refusing to consume ONS or patients with major disorders of consciousness (ex : dementia) or patients unable to consume ONS (ex : dysphagia, dysfunction of upper limbs, etc.) or patients refusing to participate to the survey.

At inclusion, the comorbidities will be assessed by the Charlson Comorbidity Index. ONS prescription and nutritional risk by the NRS 2002 score will be described at hospital and at hospital discharge for home. One month after hospital discharge for home, patient's compliance to ONS will be assessed as nutritional risk by the NRS 2002 score.

Statistics : Data will be presented as mean ± standard deviation or as numbers and percentages according to the relevance, and analyzed using Chi-squared test or unpaired t-test as required.

Study Type

Observational

Enrollment (Actual)

416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Geneva, Switzerland, 1211
        • Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospitalized adults patients with Oral Nutritive Supplements in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie

Description

Inclusion Criteria:

  • Age > 18 years
  • Hospitalization in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie
  • Oral nutritive supplements prescription during hospitalization

Exclusion Criteria:

  • Oral nutritive supplements delivery by a homecare before the admission in Geneva University Hospital wards, site of Cluse-Roseraie
  • Patient refusal to consume oral nutritive supplements
  • Major disorders of consciousness (ex : dementia)
  • Physical impossibility to consume Oral nutritive supplements (ex : dysphagia, dysfunction of upper limbs, etc.)
  • Patient refusal to participate to the survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oral Nutritive Supplements medical prescription
Time Frame: Change between prescription at hospital and prescription at hospital discharge (an expected average of 6 days after admission)
Change between prescription at hospital and prescription at hospital discharge (an expected average of 6 days after admission)

Secondary Outcome Measures

Outcome Measure
Time Frame
NRS 2002 score assessed by questionnaire
Time Frame: Change between score at oral nutritive supplements prescription at hospital and score at hospital discharge for home (an expected average of 6 days after admission) and score one month after hospital discharge for home
Change between score at oral nutritive supplements prescription at hospital and score at hospital discharge for home (an expected average of 6 days after admission) and score one month after hospital discharge for home
Indications for oral nutritive supplements prescription according to the official criteria of SSNC
Time Frame: At hospital discharge for home (an expected average of 6 days after admission)
At hospital discharge for home (an expected average of 6 days after admission)
Number of oral nutritive supplements consumed compared to prescription at hospital discharge
Time Frame: One month after hospital discharge
One month after hospital discharge
Timing for stopping the oral nutritive supplements intake if stopped
Time Frame: One month after hospital discharge
One month after hospital discharge
Reasons for stopping the oral nutritive supplements intake if stopped
Time Frame: One month after hospital discharge
One month after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Claude Pichard, MD, PhD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (ESTIMATE)

June 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Quality program ONSHUG 2015-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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