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Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers

RecruitingNAAges 18 Years - anyAllQueen's University
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In plain words

What the trial is, and whether it could suit you

\~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/clinical outcomes of ICU survivors and caregivers, with those receiving follow-up care hypothesized to have improved outcomes.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria - ICU survivors 1. Adult patients (age greater than or equal to 18 years) 2. Life expectancy greater than or equal to 6 months as determined by the attending physician 3. 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: * mechanical ventilation (any, i.e., invasive or non-invasive) * tracheostomy * 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) * lack of access to a primary care physician for clinical follow-up * access to email or mail to complete follow-up questionnaires * presence of an informal caregiver Inclusion criteria - Caregivers 1. Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above 2. Adult (age greater than or equal to 18 years) Exclusion criteria - ICU survivors and caregivers * Neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups * Inability to speak or read English (required for completion of standardized questionnaires, clinical assessments, and for participation in focus groups) * Failure to provide consent/failure to have consent provided by a substitute decision maker
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What it tests

  • Intervention
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Where

1 site
Queen's University
Kingston, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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