UndernutritionNCT02476110
The ONSHUG Survey : A Quality Care Programme
An observational study of Undernutrition, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undernutrition
- What is being tested?
- Oral nutritive supplements
- Type of treatment
- Pill or oral medicine
- How many people
- 416 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adults patients with Oral Nutritive Supplements in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie
Who may be able to join
- Age > 18 years
- Hospitalization in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie
- Oral nutritive supplements prescription during hospitalization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospital
Geneva, Canton of Geneva, 1211
About this study
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
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.
Read the 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.
- Conditions
- Undernutrition
- Being tested
- Oral nutritive supplements
- Keywords
- Oral nutritive supplements, Nutritional risk screening, Homecare
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritive supplementsDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Nutritive Supplements medical prescription
Measured: Change between prescription at hospital and prescription at hospital discharge (an expected average of 6 days after admission)
Secondary outcomes (5)
NRS 2002 score assessed by questionnaire
Measured: 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
Measured: 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
Measured: One month after hospital discharge
Timing for stopping the oral nutritive supplements intake if stopped
Measured: One month after hospital discharge
Reasons for stopping the oral nutritive supplements intake if stopped
Measured: One month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Claude Pichard, University Hospital, Geneva
- Investigators
- Claude Pichard, MD, PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476110
- Sponsor's protocol ID
- Quality program ONSHUG 2015-04
- Status last verified
- Jan 2017
- First submitted
- 1 Jun 2015
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mareschal J, Altwegg J, Berthet D, Chikhi M, Chopard P, Graf S, Sierro C, Pichard C, Genton L. Prescription and indication for oral nutritional supplements in a Swiss university hospital: a prospective survey. Swiss Med Wkly. 2017 Aug 3;147:w14475. doi: 10.4414/smw.2017.14475. eCollection 2017.
PubMed 28804864
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02476110
- Acronym / sponsor ID
- Quality program ONSHUG 2015-04
- Conditions
- Undernutrition
- Keywords
- Oral nutritive supplements, Nutritional risk screening, Homecare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adults patients with Oral Nutritive Supplements in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie
Key inclusion criteria (3 listed)
- Age > 18 years
- Hospitalization in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie
- Oral nutritive supplements prescription during hospitalization
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutritive supplements | Dietary supplement | – |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Derived from this study: PubMed 28804864Mareschal J, Altwegg J, Berthet D, Chikhi M, Chopard P, Graf S, Sierro C, Pichard C, Genton L. Prescription and indication for oral nutritional supplements in a Swiss university hospital: a prospective survey. Swiss Med Wkly. 2017 Aug 3;147:w14475. doi: 10.4414/smw.2017.14475. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Pichard, MD, PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undernutrition, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.