{"doc_desc":{"title":"Effect of organizational measures to prevent and control COVID-19 infection in nursing homes on the risk of death of residents during and after the epidemic period - PIANO COVID-19","idno":"FRESH-PEF73934-en","producers":[{"name":"Delphine PENNETIER","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE (CHUT)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73934-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73934"},{"agency":"FReSH","code":"FRESH-PEF73934"}]},"title":"Effect of organizational measures to prevent and control COVID-19 infection in nursing homes on the risk of death of residents during and after the epidemic period - PIANO COVID-19","alternate_title":"PIANO COVID-19"},"study_authorization":{"agency":[]},"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":"No"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":[],"topics":[{"topic":"Geriatrics","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":"The main objective is to compare the occurrence of global death of residents during a 1-year period (from January 2020 to December 2020) in NH and LTCU with a high level of implementation of the recommendation\/guidance to prevent and control COVID-19 NH\/LTCU residents\u2019 infection and NH and LTCU with a low level of implementation of the recommendation\/guidance to prevent and control COVID-19 NH\/LTCU. The secondary objectives are: - To compare the rate of death related to confirmed or suspected COVID cases in NH\/LTCU with a high level of implementation of the recommendation\/guidance to prevent and control COVID-19 NH\/LTCU residents\u2019 infection and NH\/LTCU with a low level of implementation of the recommendation\/guidance to prevent and control COVID-19 NH\/LTCU. - To compare the rate of death not related to COVID cases in NH\/LTCU with a high level of implementation of the recommendation\/guidance to prevent and control COVID-19 NH\/LTCU residents\u2019 infection and NH\/LTCU with a low level of implementation of the recommendation\/guidance to prevent and control COVID-19 NH\/LTCU. - To analyze the incidence of serious health events (deaths, hospitalizations) and the occurrence of COVID in residents (vaccinated and unvaccinated), in NHs and LTCUs in France during a 12-month (2021) observation period. - To analyze the occurrence of COVID in residents (vaccinated and unvaccinated), in NHs and LTCUs in France according to the rate of vaccination against COVID among the NH\u2019s\/LTCU\u2019s staff during the same observational period. From an economic perspective: - To assess the economic impact of the implementation of prevention measures applied by nursing homes staff, from healthcare system and the NH perspectives, 6, and 12 months before and 6, 12 months to 24 months after the implementation of the preventive measures. - To assess the economic impact of the vaccination among residents and NH\u2019staff, from healthcare system and the NH perspectives, 6 and 12 months before and after the vaccination campaign. These data will also provide indirect economic information about the tolerance of the vaccination. - To assess the efficiency of the high level implementation of the recommendation to prevent and control COVID-19 in comparison with the low level implementation of recommendation to prevent and control COVID-19, using a cost-effectiveness analysis at 12 and 24 months. - To assess the efficiency of the vaccination, at 6 and 12 months, among residents and healthcare professionals in comparison with no vaccination, using a cost-effectiveness analysis","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"NHs and LTCU volunteers to participate from different region of France (from low impacted to highly impacted region) will be welcomed. \",\n    \"clusion_E\": \"NHs or LTCUs that refuse to participate.\"\n}","data_kind":"['Clinical data','Economic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"9,600 persons from 120 nursing homes (coordinating nurses or coordinating physicians)."},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"03-02-2021","lastUpdatedAuto":null,"lastUpdatedManual":"23-04-2021","isContributorPI":"No","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":"No"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Excel file; CRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}