[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429813":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":35,"locations":45,"responsibleParty":77,"collaborators":18,"id":79,"slug":18,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":18,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":48,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"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",[46,64],{"facility":47,"status":48,"city":49,"state":50,"zip":18,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hamilton General Hospital","RECRUITING","Hamilton","Ontario","Canada",{"type":53,"coordinates":54},"Point",[55,56],-79.84963,43.25011,{"lat":56,"lon":55},[59,62],{"name":60,"role":38,"phone":18,"phoneExt":18,"email":61},"Krysten Gregus","gregusk@hhsc.ca",{"name":63,"role":38,"phone":18,"phoneExt":18,"email":18},"John Harlock, M.D",{"facility":65,"status":48,"city":49,"state":50,"zip":18,"country":51,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Juravinski Hospital",{"type":53,"coordinates":67},[55,56],{"lat":56,"lon":55},[70,73,75],{"name":71,"role":38,"phone":18,"phoneExt":18,"email":72},"Kelly Lawrence","lawrenceke@hhsc.ca",{"name":74,"role":38,"phone":18,"phoneExt":18,"email":18},"Ameen Patel, M.D",{"name":76,"role":38,"phone":18,"phoneExt":18,"email":18},"Flavia Borges, M.D",{"type":78,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":88,"type":89},2000,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95,96],"Surgery","Perioperative Complication",[98,99,100],"Virtual care","Remote monitoring","Acute hospital care","2024-11-13",{"date":103,"type":104},"2024-11-15","ACTUAL",{"date":106,"type":104},"2024-10-04",{"date":108,"type":89},"2026-03",{"name":5,"class":6},2]