Actively Recruiting
Led by Queen's University · Updated on 2024-12-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
Approximately 80% of patients who survive intensive care units (ICU) experience lasting cognitive, physical, and mental health challenges known as post-intensive care syndrome (PICS). Caregivers of these patients also face harmful psychosocial effects after discharge. Despite this, follow-up care is rarely provided. This trial aims to evaluate the effectiveness of specialized ICU follow-up clinics compared to standard care in improving the health and well-being of ICU survivors and their caregivers. Participants in the intervention group will attend specialized follow-up clinics at about 1 and 3 months after ICU discharge. They will also receive information materials explaining what to expect after ICU discharge and diaries to record experiences during recovery, which healthcare teams, family, and patients can use. The control group will receive usual care from their primary care providers, which can vary widely. Both ICU survivors and their caregivers are invited to participate in the follow-up clinics. During the study, participants will undergo clinical assessments measuring brain function, quality of life, anxiety, depression, post-traumatic stress, resilience, pain, fatigue, physical strength, medication use, and hospital readmissions. Caregivers will also have their burden and sleep quality assessed. Researchers will use focus groups to understand patient priorities and assess data capture, consent, enrollment, follow-up rates, and safety over six months. This study will help identify effective follow-up care to reduce long-term impacts of PICS for patients and caregivers.
CONDITIONS
Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Approximately 3 months following ICU discharge
Participants in the intervention group receive specialized follow-up care at a post-ICU follow-up clinic with additional informational materials and diaries to support recovery. Caregivers may participate alongside ICU survivors. Participants in the control group receive standard follow-up care through their primary care provider.
2 visits (in-person) at approximately 1 and 3 months following ICU discharge
Duration - Up to 6 months after ICU discharge
Participants complete clinical assessments evaluating neurocognitive function, quality of life, mental health, physical function, and caregiver burden to understand recovery and intervention impact.
Assessments may occur during clinic visits and remotely over 6 months
Total: 1 location
1
Queen's University
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
J
J G Boyd, MD PhD
N
Natasha A Jawa, MSc
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Natasha Arianne Jawa, David M Maslove, Stephanie Sibley...
https://pubmed.ncbi.nlm.nih.gov/39753245