Critical Illness, Delirium in the Intensive Care Unit
Conditions
Keywords
critical illness, delirium, post-intensive care syndrome
Brief summary
\ 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.
Detailed description
\ 80% of ICU survivors experience profound long-term cognitive, physical, and psychiatric impairments known as post-intensive care syndrome (PICS), with patients experiencing prolonged delirium or mechanical ventilation having a heightened risk. 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 pragmatic, mixed-methods, open-label randomized (1:1) controlled 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. The intervention group will receive: 1) specialized follow-up care at 1- and 3-months following discharge, 2) information packages on expectations following discharge, and 3) diaries for the healthcare team, family, and patient to journal their experiences throughout recovery. The control group will receive generalized standard of care through their primary care provider. Focus groups will be used for qualitative assessment to elucidate what patients find most important for their recovery, using a patient-centred approach. Clinical assessments will evaluate neurocognitive function, quality of life, anxiety, depression, post-traumatic stress disorder, and resiliency among both ICU survivors and caregivers; chronic pain, fatigue, activities of daily living, lower extremity strength, polypharmacy, and hospital readmissions among ICU survivors; and caregiver burden and sleep quality among caregivers. ICU survivorship extends beyond surviving the ICU. This program of research will unravel the aspects of follow-up care needed to mitigate the long-term impacts of PICS and improve patient and caregiver outcomes. This study is a first-step toward achieving this goal, by understanding barriers to successful recruitment, enrolment, data collection, and follow-up in this vulnerable cohort of ICU survivors and caregivers.
Interventions
BEHAVIORALIntervention
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. 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
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Enrolment Rate | 6 months | 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 - Data Capture Rate | 6 months | 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 |
| Feasibility - Rate of adverse events | 6 months | 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: Rate of adverse events, assessed using the number of hospital and ICU readmissions, as well as the number of visits to the emergency department at 6 months. |
| Feasibility - Consent Rate | 6 months | 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 - Follow-Up Rate | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Process evaluation | 6 months | 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. |
| Qualitative impact of intervention | 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 6 months | Chronic fatigue, as measured using the Fatigue Severity Scale (FSS) |
| Activities of daily living | 6 months | Activities of daily living (ADLs), as measured using the Katz Index of ADLs |
| Instrumental activities of daily living | 6 months | Instrumental ADLs, as measured using the Lawton IADL score |
| Neurocognition | 6 months | Neurocognitive outcomes, as measured using the MoCA |
| Resiliency | 6 months | Dyadic resiliency among ICU survivors and caregivers, as measured using the dyadic Connor-Davidson 10-item Resiliency Scale (CD-RISC-10) |
| Return to work | 6 months | To determine the effect of a post-ICU follow-up clinic intervention on return to work by ICU survivors |
| Employment status of caregivers | 6 months | Employment status relative to previous among caregivers |
| Physical function | 6 months | Lower extremity strength, as measured using the 30-second Sit-to-Stand Test |
| Weight and BMI | 6 months | 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 | 6 months | Frailty, as measured using the CFS |
| Quality of Life | 6 months | Quality of life outcomes, as measured using the SF-36 |
| Anxiety and mood | 6 months | Anxiety and depression, as measured using the HADS |
| Post-traumatic stress | 6 months | PTSD, as measured using the PTSS-14 |
| Chronic pain | 6 months | Chronic pain, as measured using the Chronic Pain Grade Scale (CPGS) |
Countries
Canada
Contacts
Primary ContactJ G Boyd, MD PhD
Backup ContactNatasha A Jawa, MSc
Outcome results
None listed