Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-07 @ 4:15 PM
Study NCT ID:
NCT02845895
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 916}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of patients responding at the level 3 of IPAQSS criterion', 'timeFrame': 'Before the surgery and 6 months after the surgery'}], 'secondaryOutcomes': [{'measure': 'Change of patients responding at the level 2 of IPAQSS criterion', 'timeFrame': 'Before the surgery and 6 months after the surgery'}, {'measure': 'Change of the cost-efficiency', 'timeFrame': 'Before the surgery and 6 months after the surgery', 'description': 'The cost of hospitalization between the 2 arms will be compared'}, {'measure': 'Change of patients responding at the level 3 and level 2 of IPAQSS criterion', 'timeFrame': '15 months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Screening for nutritional disorder', 'Comparison of two organizations', 'Indicator IPAQSS'], 'conditions': ['Nutritional Disorder']}, 'referencesModule': {'references': [{'pmid': '20434820', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19573958', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19481309', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18504063', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12765661', 'type': 'BACKGROUND', '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. doi: 10.1016/s0261-5614(02)00215-7.'}, {'pmid': '18061312', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23347962', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '20937544', 'type': 'BACKGROUND', '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.'}, {'pmid': '15297090', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17964008', 'type': 'BACKGROUND', '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. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.'}, {'pmid': '12464864', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16280442', 'type': 'BACKGROUND', '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. doi: 10.1093/ajcn/82.5.1082.'}, {'pmid': '15893857', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nIn 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?', 'detailedDescription': '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.\n\nMalnutrition therefore affects the length of hospital stays and the burden of care.\n\nMany 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.\n\nBut there is no systematic screening strategy undernutrition implementation in hospitals.\n\nThe 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%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the department of medicine-surgery-obstetric', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted in medicine-surgery-obstetrics department\n* Patient over 18 years\n\nExclusion Criteria:\n\n* Patient hospitalized less than 48 hours\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT02845895', 'acronym': 'CompaS', 'briefTitle': 'Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)', 'orgStudyIdInfo': {'id': '12 557 15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuroscience pole', 'description': 'Patient hospitalized in the department of medicine-surgery-obstetric of the neuroscience pole department', 'interventionNames': ['Other: Caregiver dedicated']}, {'label': 'Respiratory tracts pole', 'description': 'Patient hospitalized in the department of medicine-surgery-obstetric of the respiratory tracts pole department', 'interventionNames': ['Other: Classic strategy']}], 'interventions': [{'name': 'Caregiver dedicated', 'type': 'OTHER', 'description': 'Organization of nutrition screening with the help of a caregiver', 'armGroupLabels': ['Neuroscience pole']}, {'name': 'Classic strategy', 'type': 'OTHER', 'description': 'Classic organization with the training of the department team', 'armGroupLabels': ['Respiratory tracts pole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre hospitalier Universitaire de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Monelle Bertrand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital University of Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}