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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

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

• Adult (age greater than or equal to 18 years)

Locations
Other Locations
Canada
Queen's University
RECRUITING
Kingston
Contact Information
Primary
J G Boyd, MD PhD
gordon.boyd@kingstonhsc.ca
6135496666 x6228
Backup
Natasha A Jawa, MSc
tasha.jawa@queensu.ca
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 40
Treatments
Experimental: 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):~* 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
No_intervention: Control
The control group will receive generalized standard of care follow-up through their primary care provider. This follow-up is highly variable depending on the patient and their primary care provider.
Related Therapeutic Areas
Sponsors
Leads: Queen's University

This content was sourced from clinicaltrials.gov