[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429813":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":35,"locations":45,"responsibleParty":78,"collaborators":18,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":18,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":48,"whyStopped":18,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Care with Remote Automated Monitoring","EXPERIMENTAL","Patients randomized to the PVC-RAM-2 intervention will take biophysical measurements with the RAM technology and complete a daily recovery survey for 14 days after index hospital discharge, and nurses will review these results daily. Through scheduled video visits, patients will virtually interact with a nurse on days 1, 3, 7 and 14, and a physician on days 1 and 14. Patients will take a photograph of their wound daily for the first 7 days on the program, and nurses will review these pictures. If the patient's RAM measurements exceed predetermined thresholds, the patient reports specific symptoms (e.g., shortness of breath), a drug error is identified, or the virtual nurse has concerns about the patient's health that they cannot resolve, they will escalate care to a pre-assigned and available physician. Two 7-day extensions to the intervention will be possible, based on the patient's need for continued support. This decision will be based on standardized criteria.",[13],"Combination Product: Virtual care with remote automated monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"COMBINATION_PRODUCT","Virtual care with remote automated monitoring","Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.",[9],[26,30,32],{"name":27,"affiliation":28,"role":29},"Michael McGillion, PhD","McMaster University, Population Health Research Institute","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"PJ Devereaux, M.D, PhD",{"name":33,"affiliation":34,"role":29},"Sandra Ofori, M.D., PhD","Hamilton Health Sciences, Population Health Research Institute",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":18,"email":40},"Stephanie Harrison","CONTACT","905-594-0564","stephanie.harrison@phri.ca",{"name":42,"role":38,"phone":43,"phoneExt":18,"email":44},"Valerie Harvey","905-594-0563","valerie.harvey@phri.ca",[46,65],{"facility":47,"status":48,"city":49,"state":50,"zip":18,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hamilton General Hospital","RECRUITING","Hamilton","Ontario","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-79.84963,43.25011,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":18,"phoneExt":18,"email":62},"Krysten Gregus","gregusk@hhsc.ca",{"name":64,"role":38,"phone":18,"phoneExt":18,"email":18},"John Harlock, M.D",{"facility":66,"status":48,"city":49,"state":50,"zip":18,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Juravinski Hospital",{"type":54,"coordinates":68},[56,57],{"lat":57,"lon":56},[71,74,76],{"name":72,"role":38,"phone":18,"phoneExt":18,"email":73},"Kelly Lawrence","lawrenceke@hhsc.ca",{"name":75,"role":38,"phone":18,"phoneExt":18,"email":18},"Ameen Patel, M.D",{"name":77,"role":38,"phone":18,"phoneExt":18,"email":18},"Flavia Borges, M.D",{"type":79,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100429813","post-discharge-after-surgery-virtual-care-with-remote-automated-monitoring-technology-2-pvc-ram-2-trial-100429813",false,"NCT04876950","Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial","PVC-RAM-2","Inclusion Criteria:\n\n1. are ≥40 years of age;\n2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and\n3. provide informed consent to participate.\n\nExclusion Criteria:\n\n1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;\n2. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or\n3. reside in an area without cellular network coverage.","ALL","40 Years",{"count":90,"type":91},2000,"ESTIMATED","INTERVENTIONAL",[94],"NA","The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology-2 (PVC-RAM-2) Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on acute-hospital care during the 45-day follow up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. Secondary outcomes at 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. We will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post randomization.",[97,98],"Surgery","Perioperative Complication",[100,101,102],"Virtual care","Remote monitoring","Acute hospital care","2024-11-13",{"date":105,"type":106},"2024-11-15","ACTUAL",{"date":108,"type":106},"2024-10-04",{"date":110,"type":91},"2026-03",{"name":5,"class":6},2]