{"doc_desc":{"title":"Effet des mesures organisationnelles visant \u00e0 pr\u00e9venir et \u00e0 contr\u00f4ler l\u2019infection COVID-19 dans les EHPAD sur le risque de d\u00e9c\u00e8s des r\u00e9sidents pendant et apr\u00e8s la p\u00e9riode \u00e9pid\u00e9mique - PIANO COVID-19","idno":"FRESH-PEF73934-fr","producers":[{"name":"Delphine PENNETIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73934-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73934"},{"agency":"FReSH","code":"FRESH-PEF73934"}]},"title":"Effet des mesures organisationnelles visant \u00e0 pr\u00e9venir et \u00e0 contr\u00f4ler l\u2019infection COVID-19 dans les EHPAD sur le risque de d\u00e9c\u00e8s des r\u00e9sidents pendant et apr\u00e8s la p\u00e9riode \u00e9pid\u00e9mique - PIANO COVID-19","alternate_title":"PIANO COVID-19"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Yves;ROLLAND","PILabo":"GERONTOPOLE CHU TOULOUSE","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"084765399","role":"pi id"},{"title":"SIREN","uri":"263100125","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/017h5q109","role":"sponsor id"},{"title":"SIREN","uri":"263100125","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Delphine;PENNETIER","email":"pennetier.d@chu-toulouse.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/017h5q109","role":"organisation id","title":"ROR"},{"uri":"263100125","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"mesures organnisationelles mises en place"},{"keyword":"d\u00e9c\u00e8s"}],"topics":[{"topic":"G\u00e9riatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"L'objectif principal est de comparer le taux de mortalit\u00e9 globale des r\u00e9sidents sur une p\u00e9riode d'un an (de janvier 2020 \u00e0 d\u00e9cembre 2020) vivant dans des EHPAD et USLD ayant appliqu\u00e9 un niveau \u00e9lev\u00e9 de recommandations pour pr\u00e9venir l\u2019infection COVID-19 dans l\u2019EHPAD\/USLD, au taux de mortalit\u00e9 des EHPAD ayant appliqu\u00e9 un niveau faible de recommandations. Le niveau de mise en oeuvre des recommandations sera jug\u00e9 14 jours avant le pic de l\u2019\u00e9pid\u00e9mie dans la zone g\u00e9ographique de chaque EHPAD\/USLD. Les objectifs secondaires sont : - Comparer le taux de d\u00e9c\u00e8s li\u00e9 aux cas de COVID confirm\u00e9s ou suspect\u00e9s dans les EHPAD\/USLD avec un niveau \u00e9lev\u00e9 de mise en oeuvre des recommandations de pr\u00e9vention du COVID-19 ; et les EHPAD\/USLD avec un faible niveau de mise en oeuvre des recommandations. - Comparer le taux de d\u00e9c\u00e8s non li\u00e9 au COVID dans les EHPAD\/USLD avec un niveau \u00e9lev\u00e9 de mise en oeuvre des recommandations de pr\u00e9vention du COVID-19 et les EHPAD\/USLD avec un faible niveau de mise en oeuvre des recommandations. - Etudier l\u2019impact \u00e9conomique pour les EHPAD et le syst\u00e8me de sant\u00e9 de la mise en oeuvre des recommandations de pr\u00e9vention du COVID-19, 6 et 12 mois avant et apr\u00e8s la mise en oeuvre des mesures pr\u00e9ventives. - Analyser l\u2019incidence des \u00e9v\u00e9nements de sant\u00e9 graves (d\u00e9c\u00e8s, hospita-lisations) et la survenue de la COVID chez les r\u00e9sidents (vaccin\u00e9s et non vaccin\u00e9s), dans les EHPAD et les USLD en France au cours d\u2019une p\u00e9riode d\u2019observation de 12 mois (2021). - Analyser la fr\u00e9quence de la COVID chez les r\u00e9sidents (vaccin\u00e9s et non vaccin\u00e9s), dans les EHPAD et les USLD en France en fonction du taux de vaccination contre la COVID chez le personnel des EHPAD et USLD au cours de la m\u00eame p\u00e9riode d\u2019observation. D\u2019un point de vue m\u00e9dico-\u00e9conomique : - \u00e9valuer l\u2019impact \u00e9conomique de la mise en oeuvre des mesures de pr\u00e9-vention appliqu\u00e9es par le personnel soignant des EHPAD, 6 et 12 mois avant et 6, 12 et 24 mois apr\u00e8s la mise en oeuvre des mesures pr\u00e9ven-tives, en utilisant des analyses co\u00fbts-efficacit\u00e9 et l\u2019analyse co\u00fbt-effica-cit\u00e9. - \u00c9valuer l\u2019impact \u00e9conomique de la vaccination contre la COVID chez les r\u00e9sidents et le personnel des EHPAD, du point de vue du syst\u00e8me de sant\u00e9 et des EHPAD, 6 et 12 mois avant et apr\u00e8s la mise en oeuvre de la campagne de vaccination, \u00e0 l\u2019aide d\u2019analyses de co\u00fbts et de rentabilit\u00e9. Ces donn\u00e9es fourniront \u00e9galement des informations \u00e9conomiques indi-rectes sur la tol\u00e9rance de la vaccination. - \u00c9valuer l\u2019efficacit\u00e9 de la mise en oeuvre de haut niveau de recommandations visant \u00e0 pr\u00e9venir et \u00e0 contr\u00f4ler la COVID-19 par rapport \u00e0 la mise en oeuvre de faible niveau de recommandations visant \u00e0 pr\u00e9venir et \u00e0 contr\u00f4ler la COVID-19, en utilisant une analyse co\u00fbt-efficacit\u00e9 \u00e0 12 et 24 mois. - \u00c9valuer l\u2019efficacit\u00e9 de la vaccination, \u00e0 6 et 12 mois, chez les r\u00e9sidents et le personnel par rapport \u00e0 l\u2019absence de vaccination, \u00e0 l\u2019aide d\u2019une analyse co\u00fbt-efficacit\u00e9","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2021-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"EHPAD ou USLD (Unit\u00e9 de Soins de Longues Dur\u00e9es) volontaires pour participer \",\n    \"clusion_E\": \"EHPAD ou USLD (Unit\u00e9 de Soins de Longues Dur\u00e9es) Non volontaires pour participer\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es \u00e9conomiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"9600 personnes de 120 EHPAD (Infirmi\u00e8res de Coordination (IDEc) ou M\u00e9decins Coordonnateurs (MedCo))."},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"03-02-2021","lastUpdatedAuto":null,"lastUpdatedManual":"23-04-2021","isContributorPI":"Non","contributorName":"Delphine PENNETIER","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Non"},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"fichier excel; CRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"GIR, statut vital, donn\u00e9es sur la vaccination (date et type de vaccination, taille et poids \u00e0 la vaccination)","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}