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The ONSHUG Survey : A Quality Care Programme

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ClinicalTrials.gov Identifier: NCT02476110
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Claude Pichard, University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment
Undernutrition Dietary Supplement: Oral nutritive supplements

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
Actual Enrollment : 416 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : May 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. Number of oral nutritive supplements consumed compared to prescription at hospital discharge [ Time Frame: One month after hospital discharge ]
  4. Timing for stopping the oral nutritive supplements intake if stopped [ Time Frame: One month after hospital discharge ]
  5. Reasons for stopping the oral nutritive supplements intake if stopped [ Time Frame: One month after hospital discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476110


Locations
Switzerland
Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Claude Pichard, MD, PhD University Hospital, Geneva

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Claude Pichard, Professor of Nutrition and Head of Clinical Nutrition Unit, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02476110     History of Changes
Other Study ID Numbers: Quality program ONSHUG 2015-04
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by Prof. Claude Pichard, University Hospital, Geneva:
Oral nutritive supplements
Nutritional risk screening
Homecare

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders