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

Overview

\~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

• Behavioral Intervention
  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):

Primary outcome measures

• Feasibility - Consent Rate [Time frame: 6 months]
• Feasibility - Enrolment Rate [Time frame: 6 months]
• Feasibility - Follow-Up Rate [Time frame: 6 months]
• Feasibility - Data Capture Rate [Time frame: 6 months]
• Feasibility - Rate of adverse events [Time frame: 6 months]

Secondary outcome measures (2)

• Qualitative impact of intervention [Time frame: 6 months]
• Process evaluation [Time frame: 6 months]

Eligibility criteria

Inclusion criteria - 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
• 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

• Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 1 center

• Queen's University — Kingston

Publications

• Jawa NA, Hanley M, Rajagopaul A, Westphal R, Tryon M, Wakelin R, Caron C, Maslove DM, Sibley S, Muscedere J, Mathur S, Fakolade A, Kho ME, Boyd JG; Canadian Critical Care Trials Group. A Co-Designed Post-ICU Follow-Up Pathway Is Feasible and May Be Associated With Improved Psychosocial Recovery for Patients and Their Caregivers: Outcomes From the IMPACT-ICU Single-Center Randomized Controlled Tria PMID 42554982
• Jawa NA, Maslove DM, Sibley S, Muscedere J, Hunt M, Hanley M, Boyd T, Westphal R, Mathur S, Fakolade A, Tryon M, Boyd JG. IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers. BMJ Open. 2025 Jan 2;15(1):e086799. doi: 10.1136/bmjopen-2024-086799. PMID 39753245

Identifiers

NCT: NCT06681649 · 6039808

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗