The ONSHUG Survey : A Quality Care Programme

Undernutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476110
• Other study ID #: Quality program ONSHUG 2015-04
• Status: Completed
• Phase: N/A
• First received: June 1, 2015
• Last updated: January 20, 2017
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• Oral nutritive supplements

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Nutritive Supplements medical prescription		Change between prescription at hospital and prescription at hospital discharge (an expected average of 6 days after admission)
Secondary	NRS 2002 score assessed by questionnaire		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
Secondary	Indications for oral nutritive supplements prescription according to the official criteria of SSNC		At hospital discharge for home (an expected average of 6 days after admission)
Secondary	Number of oral nutritive supplements consumed compared to prescription at hospital discharge		One month after hospital discharge
Secondary	Timing for stopping the oral nutritive supplements intake if stopped		One month after hospital discharge
Secondary	Reasons for stopping the oral nutritive supplements intake if stopped		One month after hospital discharge