Clinical trial NCT06681649: Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Delirium in the Intensive Care Unit
Keywords: critical illness
delirium
post-intensive care syndrome
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Consent Rate
timeFrame: 6 months
measure: Feasibility - Enrolment Rate
timeFrame: 6 months
measure: Feasibility - Follow-Up Rate
timeFrame: 6 months
measure: Feasibility - Data Capture Rate
timeFrame: 6 months
measure: Feasibility - Rate of adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Qualitative impact of intervention
timeFrame: 6 months
measure: Process evaluation
timeFrame: 6 months
Other outcomes:
measure: Neurocognition
timeFrame: 6 months
measure: Weight and BMI
timeFrame: 6 months
measure: Clinical Outcome
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Anxiety and mood
timeFrame: 6 months
measure: Post-traumatic stress
timeFrame: 6 months
measure: Chronic pain
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
measure: Activities of daily living
timeFrame: 6 months
measure: Instrumental activities of daily living
timeFrame: 6 months
measure: Physical function
timeFrame: 6 months
measure: Resiliency
timeFrame: 6 months
measure: Return to work
timeFrame: 6 months
measure: Employment status of caregivers
timeFrame: 6 months
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
References: