Nctid:
NCT06611800
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>256}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-06-11", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Know if the presence of advance prescriptions can lead to a reduction in the number of emergency admissions for an \"avoidable reason\" by its management by a mobile palliative care team (with a maximum of 6 months before death)", "timeFrame"=>"A year", "description"=>"Collection of corresponding variables : presence/absence advance prescriptions ; number of emergency admissions for an \"avoidable reason\""}], "secondaryOutcomes"=>[{"measure"=>"Reduction in the number of emergency admissions for all reasons in their last 6 months of life.", "timeFrame"=>"A year", "description"=>"Collection of corresponding variables"}, {"measure"=>"Describe conditions of death: location, respect for the wishes of a death at home and notion of a calm death collected from the family", "timeFrame"=>"A year", "description"=>"Collection of corresponding variables"}, {"measure"=>"Describe the treatments used for PAPs: Analgesics, Anxiolytics, Anti-secretory drugs, Neuroleptics, Anti-histamines, Anti-emetics", "timeFrame"=>"A year", "description"=>"Collection of corresponding variables"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Palliative Care"]}, "referencesModule"=>{"references"=>[{"pmid"=>"20818875", "type"=>"BACKGROUND", "citation"=>"Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678."}, {"pmid"=>"28603881", "type"=>"BACKGROUND", "citation"=>"Haun MW, Estel S, Rucker G, Friederich HC, Villalobos M, Thomas M, Hartmann M. Early palliative care for adults with advanced cancer. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD011129. doi: 10.1002/14651858.CD011129.pub2."}]}, "descriptionModule"=>{"briefSummary"=>"Retrospective data collection on the files of patients cared for by the mobile palliative care team of the William Morey Hospital Center who died in 2022.", "detailedDescription"=>"Retrospective selection of patients and collection of data : pathology, identified risk, presence of caregiver, end-of-life wishes, characteristics of palliative care treatment, circumstances of death. Comparison of two groups : presence or absence of personalized advance prescriptions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients over the age of 18 cared for by the mobile palliative care team at the William Morey Hospital Center in Chalon sur Saône, who died between 01/01/2022 and 12/31/2022, having been cared for at least once in their place of life (home, EHPAD) with a visit or a call to the attending physician for advice", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Minimum 18 years old\n* Taken care of once in their place of life by a palliative care team\n* Died between 01/01/2022 and 12/31/2022 in William Morey Hospital Center\n\nExclusion Criteria: none"}, "identificationModule"=>{"nctId"=>"NCT06611800", "acronym"=>"PAPHOME", "briefTitle"=>"Personalized Advance Prescriptions in Palliative Care At HOME: Interests and Difficulties of Its Implementation", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier William Morey - Chalon sur Saône"}, "officialTitle"=>"Personalized Advance Prescriptions in Palliative Care At HOME: Interests and Difficulties of Its Implementation (PAPHOME)", "orgStudyIdInfo"=>{"id"=>"PAPHOME"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Presence or absence of personalized advance prescriptions", "description"=>"collection of data for the purpose of know the benefit of personalized advance prescriptions for patients in palliative care at home, particularly in reducing the number of visits to the emergency room and their conditions of death"}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Julie COLLOT", "role"=>"CONTACT", "email"=>"julie.collot@ch-chalon71.fr", "phone"=>"+33 3 85 91 00 48", "phoneExt"=>"+33"}, {"name"=>"Claudine DESBROSSES", "role"=>"CONTACT", "email"=>"claudine.desbrosses@ch-chalon71.fr", "phone"=>"0033385910402", "phoneExt"=>"+33"}], "overallOfficials"=>[{"name"=>"Julie COLLOT", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Centre Hospitalier William Morey"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Hospitalier William Morey - Chalon sur Saône", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Doctor", "investigatorFullName"=>"Julie COLLOT", "investigatorAffiliation"=>"Centre Hospitalier William Morey - Chalon sur Saône"}}}}
