Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's University

About this trial

\~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 criteria

Qualifiers

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

mechanical ventilation (any, i.e., invasive or non-invasive)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intervention

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators