[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568470":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":53,"collaborators":18,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Queen's University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","The intervention group will receive follow-up care through the specialized post-ICU follow-up clinic at KHSC at approximately 1- and 3-months following ICU discharge. Caregivers will also be invited to participate in the follow-up clinic along with the ICU survivor participant.\n\nIn addition to receiving specialized follow-up clinical care, ICU survivor participants and their caregivers will also receive the following additional items as part of a bundled care intervention program (see Appendix):\n\n* Informational pamphlet on critical illness and expectations following ICU discharge\n* Flyer on critical illness and expectations following ICU discharge (brief version, which may be placed on the participant's refrigerator or other location at home as a consistent reminder)\n* Diaries in which the healthcare team, family members, and the patient themselves are able to journal their experiences, updates, progress, and barriers in the ICU and following discharge",[13],"Behavioral: Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","The control group will receive generalized standard of care follow-up through their primary care provider. This follow-up is highly variable depending on the patient and their primary care provider.",null,[20],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":18},"BEHAVIORAL",[9],[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"J G Boyd, MD PhD","CONTACT","6135496666 x6228","6228","gordon.boyd@kingstonhsc.ca",{"name":31,"role":26,"phone":18,"phoneExt":18,"email":32},"Natasha A Jawa, MSc","tasha.jawa@queensu.ca",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Kingston","Ontario","K7L 2V7","Canada","CA",{"type":42,"coordinates":43},"Point",[44,45],-76.48098,44.22976,{"lat":45,"lon":44},[48,51],{"name":49,"role":26,"phone":50,"phoneExt":18,"email":29},"Gordon Boyd, MD PhD FRCPC","6135392754",{"name":52,"role":26,"phone":18,"phoneExt":18,"email":18},"J G Boyd, MD PhD FRCPC",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr. Gordon Boyd","Associate Professor","100568470","pilot-feasibility-study-of-a-pragmatic-mixed-methods-randomized-controlled-trial-on-a-follow-up-bundle-of-care-for-icu-survivors-and-caregivers-100568470",false,"NCT06681649","Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers","Improving Medical and Psychological Outcomes After Discharge - Feasibility Study for a Pragmatic, Mixed-methods, Open-label Randomized Controlled Trial Examining the Effectiveness of a Follow-up Clinic for ICU Survivors and Caregivers","IMPACT-ICU","Inclusion criteria - ICU survivors\n\n1. Adult patients (age greater than or equal to 18 years)\n2. Life expectancy greater than or equal to 6 months as determined by the attending physician\n3. High risk for long-term functional sequelae following ICU discharge, defined as ICU stay greater than or equal to 4 days, or involving at least one of:\n\n   * mechanical ventilation (any, i.e., invasive or non-invasive)\n   * tracheostomy\n   * delirium (defined as Confusion Assessment Method (CAM) positive or documented history of delirium in the patient's medical record by the clinical care team at some point during their ICU admission)\n   * lack of access to a primary care physician for clinical follow-up\n   * access to email or mail to complete follow-up questionnaires\n   * presence of an informal caregiver\n\nInclusion criteria - Caregivers\n\n1. Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above\n2. Adult (age greater than or equal to 18 years)\n\nExclusion criteria - ICU survivors and caregivers\n\n* Neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups\n* Inability to speak or read English (required for completion of standardized questionnaires, clinical assessments, and for participation in focus groups)\n* Failure to provide consent\u002Ffailure to have consent provided by a substitute decision maker",true,"ALL","18 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","\\~80% of ICU survivors experience profound long-term cognitive, physical, and psychiatric impairments known as post-intensive care syndrome (PICS). Caregivers additionally experience similar detrimental psychosocial effects following discharge. Despite this knowledge, follow-up care is almost non-existent. ICU follow-up clinics may mitigate these long-term impacts, but lack evaluation of their effectiveness. This trial will evaluate the effectiveness of ICU follow-up clinics vs. standard-of-care in improving qualitative\u002Fclinical outcomes of ICU survivors and caregivers, with those receiving follow-up care hypothesized to have improved outcomes.",[76,77],"Critical Illness","Delirium in the Intensive Care Unit",[79,80,81],"critical illness","delirium","post-intensive care syndrome","2024-11-29",{"date":84,"type":85},"2024-12-04","ACTUAL",{"date":87,"type":85},"2024-06-01",{"date":89,"type":70},"2025-06-01",{"name":5,"class":6},1]