Recruiting

Observational Study

Sponsor:

Queen's University

Code:

NCT06681649

Conditions

Critical Illness

Delirium in the Intensive Care Unit

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Intervention

Study Details

Brief 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.

Conditions

Critical Illness

Delirium in the Intensive Care Unit

Study ID

NCT06681649

Start date

Jun 1, 2024

Status verified date

Nov, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion criteria - ICU survivors

1. Adult patients (age greater than or equal to 18 years)
2. Life expectancy greater than or equal to 6 months as determined by the attending physician
3. 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

1. Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above
2. 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

J G Boyd, MD PhD

6135496666 x6228gordon.boyd@kingstonhsc.ca

Natasha A Jawa, MSc

tasha.jawa@queensu.ca

Locations

Queen's University

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Gordon Boyd, MD PhD FRCPC

6135392754gordon.boyd@kingstonhsc.ca

More Information

Sponsor

Queen's University

Last update posted

Dec 4, 2024

Last verified

Nov, 2024

Keywords

  • critical illness
  • delirium
  • post-intensive care syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2024-12-04.