RecruitingNot ApplicableNCT06681649

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

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

Sponsor

Queen's University

Enrollment

40 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Critical Illness Delirium in the Intensive Care Unit

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

Min Age: 18 Years

Inclusion Criteria11

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)

Exclusion Criteria3

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

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Interventions

BEHAVIORALIntervention

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