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

Nutritional Disorder Clinical Trial

— CompaS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845895
• Other study ID #: 12 557 15
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: November 27, 2017
• Start date: September 2014
• Est. completion date: October 2016

Study information

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

Clinical 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.

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?

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 916
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted in medicine-surgery-obstetrics department

• Patient over 18 years

Exclusion Criteria:

• Patient hospitalized less than 48 hours

• Patients under 18 years

Related Conditions & MeSH terms

• Disease
• Nutrition Disorders
• Nutritional Disorder

Intervention

Other:
• Caregiver dedicated
Organization of nutrition screening with the help of a caregiver
• Classic strategy
Classic organization with the training of the department team

Locations

Country	Name	City	State
France	Centre hospitalier Universitaire de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (13)

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. — View Citation

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. — View Citation

Elia M, Zellipour L, Stratton RJ. To screen or not to screen for adult malnutrition? Clin Nutr. 2005 Dec;24(6):867-84. Review. — View Citation

Imoberdorf R, Meier R, Krebs P, Hangartner PJ, Hess B, Stäubli M, Wegmann D, Rühlin 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. — View Citation

Johansen N, Kondrup J, Plum LM, Bak L, Nørregaard 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. — View Citation

Korfali G, Gündogdu H, Aydintug S, Bahar M, Besler T, Moral AR, Oguz M, Sakarya M, Uyar M, Kiliçturgay 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Oct 25. — View Citation

Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. Epub 2007 Dec 3. Review. — View Citation

Schindler K, Pernicka E, Laviano A, Howard P, Schütz 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. — View Citation

Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krähenbühl 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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of patients responding at the level 3 of IPAQSS criterion		Before the surgery and 6 months after the surgery
Secondary	Change of patients responding at the level 2 of IPAQSS criterion		Before the surgery and 6 months after the surgery
Secondary	Change of the cost-efficiency	The cost of hospitalization between the 2 arms will be compared	Before the surgery and 6 months after the surgery
Secondary	Change of patients responding at the level 3 and level 2 of IPAQSS criterion		15 months after the surgery