Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06681649

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

Led by Queen's University · Updated on 2024-12-04

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\~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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult ICU survivors aged 18 years or older
  • Life expectancy of 6 months or more as assessed by a physician
  • High risk for long-term effects after ICU discharge, including ICU stay of 4 days or more, mechanical ventilation, tracheostomy, delirium during ICU stay, no access to primary care, access to email or mail for follow-up, and presence of an informal caregiver
  • Informal caregivers 18 years or older for ICU survivors meeting the above criteria
Not Eligible

You will not qualify if you...

  • Neurological or communication difficulties preventing participation in assessments or focus groups
  • Inability to speak or read English
  • Failure to provide consent or lack of substitute decision maker consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Queen's University

Kingston, Ontario, Canada, K7L 2V7

Actively Recruiting

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Research Team

J

J G Boyd, MD PhD

CONTACT

N

Natasha A Jawa, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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