Nutritional DisorderCompaSNCT02845895

Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)

An observational study of Nutritional Disorder, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The prevalence of malnutrition in hospital is very high (30 percent) with major consequences in terms of morbidity and mortality, generating significant health care costs. The positive impact of its support is demonstrated. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nutritional Disorder
What is being tested?: Caregiver dedicated and Classic strategy
How many people: 916 participants
Where: 1 siteFrance
Study dates: Sep 2014to Oct 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: Patients hospitalized in the department of medicine-surgery-obstetric

Who may be able to join

Patients admitted in medicine-surgery-obstetrics department
Patient over 18 years

Who cannot join

Patient hospitalized less than 48 hours
Patients under 18 years

Trial locations and contacts

1 site in 1 country.

France1 site

Centre hospitalier Universitaire de Toulouse
Toulouse, 31059

Other trials in France

About this study

The HAS (French High Sanitary Authority) recommends a screening of all adult hospitalized in the first 48 hours, with no consensus regarding the organization of screening within care services. Various strategies have been implemented. Although this screening is part of the nursing role, old and recent studies show that it is not done systematically and nutritional disorders are largely under-diagnosed and therefore untreated.

The investigators assume that an organization of screening for eating disorders, based on a caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour l'Amélioration de la Qualité et de la Sécurité des Soins) which is an indicator for the improvement of the quality and security of care) Screening indicator of nutritional disorders Level 3, compared to an organization "classic" involving the care teams in their entirety. This indicator reflects the care system performance.

In this study, patients will have no intervention. Only the organization of the care staff will be adapted but with no changes on the care of patients?

Read the detailed description

Undernutrition in the hospital is a public health issue. The impacts of this malnutrition are known , with consequences clearly established on the morbidity, mortality and quality of life. Undernutrition is an independent risk factor for mortality (5). In terms of morbidity, the most frequently reported consequences are infections, postoperative complications (delayed healing, in particular nosocomial infections, risk of pressure ulcers) and pejorative impact on the prognosis of chronic diseases such as respiratory failure , heart and kidney.

Malnutrition therefore affects the length of hospital stays and the burden of care.

Many studies have shown the positive impact of the medical care of malnutrition on morbidity and mortality, whether intervention studies in general hospital population or in specific pathologies.

But there is no systematic screening strategy undernutrition implementation in hospitals.

The investigators assume that the organization of screening for eating disorders based on a caregiver specifically dedicated to this activity, improves the indicator IPAQSS Screening indicator of nutritional disorders level 3 compared with a "classic" organization shared between different actors of care. This indicator reflects the care system performance This organization must advance quickly and significantly the number of patients evaluated nutritionally and help reach a level of completeness close to 100%.

Conditions: Nutritional Disorder
Being tested: Caregiver dedicated, Classic strategy
Keywords: Screening for nutritional disorder, Comparison of two organizations, Indicator IPAQSS
Medical subject headings: Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caregiver dedicatedOther
Organization of nutrition screening with the help of a caregiver
Classic strategyOther
Classic organization with the training of the department team

Study groups in NCT02845895
Study group	Role	What they receive
Neuroscience pole		Patient hospitalized in the department of medicine-surgery-obstetric of the neuroscience pole department Receives: Other: Caregiver dedicated
Respiratory tracts pole		Patient hospitalized in the department of medicine-surgery-obstetric of the respiratory tracts pole department Receives: Other: Classic strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of patients responding at the level 3 of IPAQSS criterion
Measured: Before the surgery and 6 months after the surgery

Secondary outcomes (3)

Change of patients responding at the level 2 of IPAQSS criterion
Measured: Before the surgery and 6 months after the surgery
Change of the cost-efficiency
The cost of hospitalization between the 2 arms will be compared
Measured: Before the surgery and 6 months after the surgery
Change of patients responding at the level 3 and level 2 of IPAQSS criterion
Measured: 15 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Oct 2016

First posted27 Jul 2016 (estimated)
Study startSep 2014
Primary completionJul 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Nutritional DisorderStudies of the same condition, open and under way.
More trials run by University Hospital, ToulouseThe 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: 916 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02845895
Sponsor's protocol ID: 12 557 15
Acronym: CompaS
Status last verified: Nov 2017
First submitted: 19 Jul 2016
Last updated: 29 Nov 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Schindler K, Pernicka E, Laviano A, Howard P, Schutz T, Bauer P, Grecu I, Jonkers C, Kondrup J, Ljungqvist O, Mouhieddine M, Pichard C, Singer P, Schneider S, Schuh C, Hiesmayr M; NutritionDay Audit Team. How nutritional risk is assessed and managed in European hospitals: a survey of 21,007 patients findings from the 2007-2008 cross-sectional nutritionDay survey. Clin Nutr. 2010 Oct;29(5):552-9. doi: 10.1016/j.clnu.2010.04.001.
PubMed 20434820
Imoberdorf R, Meier R, Krebs P, Hangartner PJ, Hess B, Staubli M, Wegmann D, Ruhlin M, Ballmer PE. Prevalence of undernutrition on admission to Swiss hospitals. Clin Nutr. 2010 Feb;29(1):38-41. doi: 10.1016/j.clnu.2009.06.005. Epub 2009 Jul 1.
PubMed 19573958
Korfali G, Gundogdu H, Aydintug S, Bahar M, Besler T, Moral AR, Oguz M, Sakarya M, Uyar M, Kilicturgay S. Nutritional risk of hospitalized patients in Turkey. Clin Nutr. 2009 Oct;28(5):533-7. doi: 10.1016/j.clnu.2009.04.015. Epub 2009 May 28.
PubMed 19481309
Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krahenbuhl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9. doi: 10.1016/j.clnu.2008.03.012. Epub 2008 May 27.
PubMed 18504063
Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.
PubMed 12765661
Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.
PubMed 18061312
Lim SL, Daniels L. Reply--Malnutrition and its impact on cost of hospitalization, length of stay, readmission and 3-year mortality. Clin Nutr. 2013 Jun;32(3):489-90. doi: 10.1016/j.clnu.2012.12.014. Epub 2013 Jan 11. No abstract available.
PubMed 23347962
Starke J, Schneider H, Alteheld B, Stehle P, Meier R. Short-term individual nutritional care as part of routine clinical setting improves outcome and quality of life in malnourished medical patients. Clin Nutr. 2011 Apr;30(2):194-201. doi: 10.1016/j.clnu.2010.07.021.
PubMed 20937544
Johansen N, Kondrup J, Plum LM, Bak L, Norregaard P, Bunch E, Baernthsen H, Andersen JR, Larsen IH, Martinsen A. Effect of nutritional support on clinical outcome in patients at nutritional risk. Clin Nutr. 2004 Aug;23(4):539-50. doi: 10.1016/j.clnu.2003.10.008.
PubMed 15297090
Norman K, Kirchner H, Freudenreich M, Ockenga J, Lochs H, Pirlich M. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Clin Nutr. 2008 Feb;27(1):48-56. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.
PubMed 17964008
Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
PubMed 12464864
Kruizenga HM, Van Tulder MW, Seidell JC, Thijs A, Ader HJ, Van Bokhorst-de van der Schueren MA. Effectiveness and cost-effectiveness of early screening and treatment of malnourished patients. Am J Clin Nutr. 2005 Nov;82(5):1082-9. doi: 10.1093/ajcn/82.5.1082.
PubMed 16280442
Elia M, Zellipour L, Stratton RJ. To screen or not to screen for adult malnutrition? Clin Nutr. 2005 Dec;24(6):867-84. doi: 10.1016/j.clnu.2005.03.004.
PubMed 15893857

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency

All Nutritional Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)
ClinicalTrials.gov ID: NCT02845895
Acronym / sponsor ID: CompaS / 12 557 15
Conditions: Nutritional Disorder
Keywords: Screening for nutritional disorder, Comparison of two organizations, Indicator IPAQSS
Study type: Observational
Recruitment status: Completed
Enrolment: 916 participants (actual)
Lead sponsor: University Hospital, ToulouseUniversity, hospital or other
Study start: Sep 2014
Primary completion: Jul 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 27 Jul 2016 (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.

In this study, patients will have no intervention. Only the organization of the care staff will be adapted but with no changes on the care of patients?

Detailed description

Malnutrition therefore affects the length of hospital stays and the burden of care.

Many studies have shown the positive impact of the medical care of malnutrition on morbidity and mortality, whether intervention studies in general hospital population or in specific pathologies.

But there is no systematic screening strategy undernutrition implementation in hospitals.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Neuroscience pole	–	Other: Caregiver dedicatedPatient hospitalized in the department of medicine-surgery-obstetric of the neuroscience pole department
Respiratory tracts pole	–	Other: Classic strategyPatient hospitalized in the department of medicine-surgery-obstetric of the respiratory tracts pole department

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients hospitalized in the department of medicine-surgery-obstetric

Key inclusion criteria (2 listed)

Patients admitted in medicine-surgery-obstetrics department
Patient over 18 years

Key exclusion criteria (2 listed)

Patient hospitalized less than 48 hours
Patients under 18 years

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
Caregiver dedicatedOrganization of nutrition screening with the help of a caregiver	Other	Neuroscience pole
Classic strategyClassic organization with the training of the department team	Other	Respiratory tracts pole

Primary outcome

Change of patients responding at the level 3 of IPAQSS criterion
Time frame: Before the surgery and 6 months after the surgery

3 secondary outcomes

Change of patients responding at the level 2 of IPAQSS criterion
Time frame: Before the surgery and 6 months after the surgery
Change of the cost-efficiency
Time frame: Before the surgery and 6 months after the surgery
Change of patients responding at the level 3 and level 2 of IPAQSS criterion
Time frame: 15 months after the surgery

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 29 Nov 2017.
Background: PubMed 20434820Schindler K, Pernicka E, Laviano A, Howard P, Schutz T, Bauer P, Grecu I, Jonkers C, Kondrup J, Ljungqvist O, Mouhieddine M, Pichard C, Singer P, Schneider S, Schuh C, Hiesmayr M; NutritionDay Audit Team. How nutritional risk is assessed and managed in European hospitals: a survey of 21,007 patients findings from the 2007-2008 cross-sectional nutritionDay survey. Clin Nutr. 2010 Oct;29(5):552-9. doi: 10.1016/j.clnu.2010.04.001.
Background: PubMed 19573958Imoberdorf R, Meier R, Krebs P, Hangartner PJ, Hess B, Staubli M, Wegmann D, Ruhlin M, Ballmer PE. Prevalence of undernutrition on admission to Swiss hospitals. Clin Nutr. 2010 Feb;29(1):38-41. doi: 10.1016/j.clnu.2009.06.005. Epub 2009 Jul 1.
Background: PubMed 19481309Korfali G, Gundogdu H, Aydintug S, Bahar M, Besler T, Moral AR, Oguz M, Sakarya M, Uyar M, Kilicturgay S. Nutritional risk of hospitalized patients in Turkey. Clin Nutr. 2009 Oct;28(5):533-7. doi: 10.1016/j.clnu.2009.04.015. Epub 2009 May 28.
Background: PubMed 18504063Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krahenbuhl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9. doi: 10.1016/j.clnu.2008.03.012. Epub 2008 May 27.
Background: PubMed 12765661Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.
Background: PubMed 18061312Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.
Background: PubMed 23347962Lim SL, Daniels L. Reply--Malnutrition and its impact on cost of hospitalization, length of stay, readmission and 3-year mortality. Clin Nutr. 2013 Jun;32(3):489-90. doi: 10.1016/j.clnu.2012.12.014. Epub 2013 Jan 11. No abstract available.
Background: PubMed 20937544Starke J, Schneider H, Alteheld B, Stehle P, Meier R. Short-term individual nutritional care as part of routine clinical setting improves outcome and quality of life in malnourished medical patients. Clin Nutr. 2011 Apr;30(2):194-201. doi: 10.1016/j.clnu.2010.07.021.
Background: PubMed 15297090Johansen N, Kondrup J, Plum LM, Bak L, Norregaard P, Bunch E, Baernthsen H, Andersen JR, Larsen IH, Martinsen A. Effect of nutritional support on clinical outcome in patients at nutritional risk. Clin Nutr. 2004 Aug;23(4):539-50. doi: 10.1016/j.clnu.2003.10.008.
Background: PubMed 17964008Norman K, Kirchner H, Freudenreich M, Ockenga J, Lochs H, Pirlich M. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Clin Nutr. 2008 Feb;27(1):48-56. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.
Background: PubMed 12464864Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
Background: PubMed 16280442Kruizenga HM, Van Tulder MW, Seidell JC, Thijs A, Ader HJ, Van Bokhorst-de van der Schueren MA. Effectiveness and cost-effectiveness of early screening and treatment of malnourished patients. Am J Clin Nutr. 2005 Nov;82(5):1082-9. doi: 10.1093/ajcn/82.5.1082.
Individual participant dataSharing planned: No

Related trials for Nutritional Disorder

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency

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.

Monelle Bertrand, MD, PhD principal investigator

Hospital University of Toulouse

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 Nutritional Disorder, run by University Hospital, Toulouse at 1 site in France.

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 2 inclusion and 2 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 29 Nov 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 France. 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?

Change of patients responding at the level 3 of IPAQSS criterion (time frame: Before the surgery and 6 months after the surgery). 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 NCT02845895, which also lists 13 linked publications.

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 29 Nov 2017.