\~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.
ICU survivors
Adult patients (age greater than or equal to 18 years)
Life expectancy greater than or equal to 6 months as determined by the attending physician
mechanical ventilation (any, i.e., invasive or non-invasive)
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
Parallel
Intervention
BehavioralThe 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. In 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): * Informational pamphlet on critical illness and expectations following ICU discharge * 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) * 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
Feasibility - Consent Rate
To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measure: Consent rate, measured as the proportion of eligible population who consent to participate
Feasibility - Enrolment Rate
To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Enrolment rate, measured as the proportion of consented participants who are randomized
Feasibility - Follow-Up Rate
To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Follow-up rate, measured as the proportion of enrolled participants who complete follow-up visits at 1-, 3-, and 6-months
Feasibility - Data Capture Rate
To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Data capture rate, measured as the percentage of data elements acquired at each study time point
Qualitative impact of intervention
To determine the qualitative impact of a post-ICU follow-up care intervention on patients and caregivers, as assessed via qualitative analysis of focus group discussions.
Process evaluation
To perform a process evaluation of the multimodal ICU follow-up bundle of care intervention to understand the implementation, acceptability, content, barriers, and facilitators to use of diaries, informational materials, and the follow-up clinic.
Neurocognition
Neurocognitive outcomes, as measured using the MoCA
Weight and BMI
To determine the effect of a post-ICU follow-up clinic intervention on changes in weight and body-mass index (BMI) following ICU discharge
Clinical Outcome
Frailty, as measured using the CFS
Quality of Life
Quality of life outcomes, as measured using the SF-36
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