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
|Condition or disease||Intervention/treatment|
|Undernutrition||Dietary Supplement: Oral nutritive supplements|
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|
|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|
- 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) ]
- 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 ]
- 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) ]
- Number of oral nutritive supplements consumed compared to prescription at hospital discharge [ Time Frame: One month after hospital discharge ]
- Timing for stopping the oral nutritive supplements intake if stopped [ Time Frame: One month after hospital discharge ]
- Reasons for stopping the oral nutritive supplements intake if stopped [ Time Frame: One month after hospital discharge ]
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
|Geneva University Hospital|
|Geneva, Switzerland, 1211|
|Principal Investigator:||Claude Pichard, MD, PhD||University Hospital, Geneva|