[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491627":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":33,"responsibleParty":152,"collaborators":155,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":17,"eligibilityCriteria":185,"healthyVolunteers":181,"sex":186,"minAge":187,"maxAge":17,"enrollmentInfo":188,"targetDuration":17,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":36,"whyStopped":17,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},{"fullName":5,"class":6},"University of Oslo","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Intervention arm","Clusters (medical\u002Fgeriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period.",[12],"Other: Implementation support program",{"label":14,"type":15,"description":16,"interventionNames":17},"Control arm","NO_INTERVENTION","Clusters (medical\u002Fgeriatric hospital units) in the control arm receives no implementation support program during the trial period.\n\nThese units will receive the implementation support program after the trial period.",null,[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":17},"Implementation support program","The intervention consists of:\n\nI Implementation strategies:\n\n1.1 Ensuring leadership commitment 1.2 Responsive evaluation 1.3 Whole ward approach 1.4 Train the trainer model 1.5 Sustainability after the study\n\nII Implementation interventions 2.1 Implementation team 2.2 ACP coordinator 2.3 Training and supervision: Kick-off, training of resource persons and health care personnel including practical exercises, network conferences 2.4 Toolkit and shared resources: ACP guideline, teaching material, information leaflets, documentation templates etc. 2.5 Structured fidelity measurements of the implementation level of a) the implementation interventions and b) the clinical intervention, with tailored feedback and supervision\n\nIII Clinical intervention: Advance Care Planning 3.1 Routine information and invitation to Advance Care Planning to all eligible patients 3.2 Written information to patients and relatives 3.3 Documentation and collaboration with other health care levels",[9],[24],{"name":25,"affiliation":26,"role":27},"Reidar Pedersen, PhD","Professor, Centre for medical ethics, University of Oslo","PRINCIPAL_INVESTIGATOR",[29],{"name":25,"role":30,"phone":31,"phoneExt":17,"email":32},"CONTACT","+47 41575987","reidar.pedersen@medisin.uio.no",[34,52,62,72,82,93,103,113,118,125,132,142],{"facility":35,"status":36,"city":37,"state":38,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Vestre Viken Hospital Trust, Bærum","RECRUITING","Oslo","Bærum kommune","Norway","NO",{"type":42,"coordinates":43},"Point",[44,45],10.74609,59.91273,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},"Maria Romøren","91377693","maria.romoren@medisin.uio.no",{"facility":53,"status":36,"city":54,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Hospital of Southern Norway, Arendal","Arendal",{"type":42,"coordinates":56},[57,58],8.77253,58.46151,{"lat":58,"lon":57},[61],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":63,"status":36,"city":64,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Vestre Viken Hospital Trust, Drammen","Drammen",{"type":42,"coordinates":66},[67,68],10.20449,59.74389,{"lat":68,"lon":67},[71],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":73,"status":36,"city":74,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Innlandet Hospital Trust, Elverum","Elverum",{"type":42,"coordinates":76},[77,78],11.56231,60.88191,{"lat":78,"lon":77},[81],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":83,"status":36,"city":84,"state":17,"zip":85,"country":39,"countryCode":40,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Innlandet Hospital Trust, Gjøvik","Gjøvik","3121",{"type":42,"coordinates":87},[88,89],10.69155,60.79574,{"lat":89,"lon":88},[92],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":94,"status":36,"city":95,"state":17,"zip":85,"country":39,"countryCode":40,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Vestre Viken Hospital Trust, Kongsberg","Kongsberg",{"type":42,"coordinates":97},[98,99],9.65017,59.66858,{"lat":99,"lon":98},[102],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":104,"status":36,"city":105,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Hospital of Southern Norway, Kristiansand","Kristiansand",{"type":42,"coordinates":107},[108,109],7.9956,58.14671,{"lat":109,"lon":108},[112],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":114,"status":36,"city":115,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":17,"geoPoint":17,"contacts":116},"Akershus University Hospital","Lørenskog",[117],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":119,"status":36,"city":37,"state":17,"zip":85,"country":39,"countryCode":40,"cosmosGeoPoint":120,"geoPoint":122,"contacts":123},"Diakonhjemmet Hospital",{"type":42,"coordinates":121},[44,45],{"lat":45,"lon":44},[124],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":126,"status":36,"city":37,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"Oslo University Hospital",{"type":42,"coordinates":128},[44,45],{"lat":45,"lon":44},[131],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":133,"status":36,"city":134,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Østfold Hospital Trust","Sarpsborg",{"type":42,"coordinates":136},[137,138],11.10962,59.28391,{"lat":138,"lon":137},[141],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"facility":143,"status":36,"city":144,"state":17,"zip":17,"country":39,"countryCode":40,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Vestfold Hospital Trust","Tønsberg",{"type":42,"coordinates":146},[147,148],10.40762,59.26754,{"lat":148,"lon":147},[151],{"name":49,"role":30,"phone":50,"phoneExt":17,"email":51},{"type":27,"investigatorFullName":153,"investigatorTitle":154,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Reidar Pedersen","Professor",[156,158,160,162,165,167,169,171,173,175,177,178],{"name":157,"class":6},"Oslo Metropolitan University",{"name":159,"class":6},"Norwegian University of Science and Technology",{"name":161,"class":6},"The Research Council of Norway",{"name":163,"class":164},"Helse Sor-Ost","OTHER_GOV",{"name":166,"class":6},"Sykehuset Innlandet HF",{"name":168,"class":6},"Vestre Viken Hospital Trust",{"name":170,"class":6},"Ostfold Hospital Trust",{"name":172,"class":6},"The Hospital of Vestfold",{"name":174,"class":6},"Hospital of Southern Norway Trust",{"name":176,"class":6},"University Hospital, Akershus",{"name":126,"class":6},{"name":119,"class":6},"100491627","advanced-care-planning-for-the-severely-ill-home-dwelling-elderly-100491627",false,"NCT05681585","Advanced Care Planning for the Severely Ill Home-dwelling Elderly","Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial","Inclusion and exclusion criteria for patients and relatives the quantitative and triadic sub-study:\n\nInclusion criteria for patients:\n\n* Home-dwelling\n* 70 years or older\n* Acutely admitted to the participating unit\n* Sufficient language proficiency in Norwegian to answer the questionnaire\n* Clinical frailty score of 4 or more\n* The physician responsible for the patient's medical care answers \"no\" to \"Surprise question\" from Gold Standards Framework proactive identification guidance\n* Both patient and a close relative (preferably the closest relative) would participate in ACP together if offered\n* Both patient and the close relative consent to participate in the research project\n\nExclusion criteria for patients:\n\n* The patient is not competent to consent to research participation\n* The patient is expected to die within 24 hours\n* The patient has participated in ACP prior to the current hospital admission\n* In the intervention arm\n\n  * ACP is not conducted with patient, next of kin and physician before hospital discharge\n  * The clinician that participated in the ACP conversation has not consented to research participation\n* In the control arm\n\n  * The patient would not have been able to participate in ACP during hospitalization\n  * An attending clinician has not consented to research participation\n\nInclusion criteria for relatives:\n\n* A close relative of a patient who fulfill all inclusion criteria and no exclusion criteria; and who would be willing to participate in ACP together with the patient if offered\n* 18 years or older\n* Sufficient language proficiency in Norwegian to answer the questionnaire\n* Both patient and the close relative consent to participate in the research project\n\nExclusion criteria for relatives:\n\n* The relative is not competent to consent to research participation\n* In the intervention arm\n\n  * ACP is not carried out with the patient, next of kin and attending clinician before hospital discharge\n* In the control arm\n\n  * The relative would not have been able to participate in ACP during hospitalization","ALL","70 Years",{"count":189,"type":190},2000,"ESTIMATED","INTERVENTIONAL",[193],"NA","This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design.\n\nTwelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Of the twelve clusters, half will receive implementation support and training immediately, and the other half will receive similar support after the intervention period. The study includes 1) assessment of implementation outcomes (fidelity) in the participating units,2) health service and clinical outcomes including a) questionnaires to all staff in the units before and after the implementation period, questionnaires to attending clinicians and qualitative interviews with health personnel and local unit leaders b) questionnaires to patients and their relatives, patients records and data from central health registers and qualitative interviews with patients and relatives. Furthermore we will assess barriers and facilitators for advance care planning in 1) a wider health service context, and 2) at the national, regional and municipal level, and do economic analyses.",[196],"Advance Care Planning",[198,199,200,201,202,203,204,205,206,207,208],"Implementation science","Decision-making processes","Hospital","Geriatric","Next of kin","Clinical ethics","Qualitative methods","Cluster randomized clinical trial","Complex intervention","Health services for the aged","End of life","2025-04-02",{"date":211,"type":212},"2025-04-06","ACTUAL",{"date":214,"type":212},"2023-10-18",{"date":216,"type":190},"2026-12",{"name":5,"class":6},12]