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

NCT ID: NCT06681649

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-01

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.

Detailed Description

~80% of ICU survivors experience profound long-term cognitive, physical, and psychiatric impairments known as post-intensive care syndrome (PICS), with patients experiencing prolonged delirium or mechanical ventilation having a heightened risk. 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 pragmatic, mixed-methods, open-label randomized (1:1) controlled 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.

The intervention group will receive: 1) specialized follow-up care at 1- and 3-months following discharge, 2) information packages on expectations following discharge, and 3) diaries for the healthcare team, family, and patient to journal their experiences throughout recovery. The control group will receive generalized standard of care through their primary care provider. Focus groups will be used for qualitative assessment to elucidate what patients find most important for their recovery, using a patient-centred approach. Clinical assessments will evaluate neurocognitive function, quality of life, anxiety, depression, post-traumatic stress disorder, and resiliency among both ICU survivors and caregivers; chronic pain, fatigue, activities of daily living, lower extremity strength, polypharmacy, and hospital readmissions among ICU survivors; and caregiver burden and sleep quality among caregivers.

ICU survivorship extends beyond surviving the ICU. This program of research will unravel the aspects of follow-up care needed to mitigate the long-term impacts of PICS and improve patient and caregiver outcomes. This study is a first-step toward achieving this goal, by understanding barriers to successful recruitment, enrolment, data collection, and follow-up in this vulnerable cohort of ICU survivors and caregivers.

Conditions

Critical Illness; Delirium in the Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gordon Boyd

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen's University

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

J G Boyd, MD PhD

Role: CONTACT

gordon.boyd@kingstonhsc.ca

6135496666 x6228 ext. 6228

Natasha A Jawa, MSc

Role: CONTACT

tasha.jawa@queensu.ca

Facility Contacts

Gordon Boyd, MD PhD FRCPC

Role: primary

gordon.boyd@kingstonhsc.ca

6135392754

J G Boyd, MD PhD FRCPC

Role: backup

References

Jawa NA, Maslove DM, Sibley S, Muscedere J, Hunt M, Hanley M, Boyd T, Westphal R, Mathur S, Fakolade A, Tryon M, Boyd JG. IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers. BMJ Open. 2025 Jan 2;15(1):e086799. doi: 10.1136/bmjopen-2024-086799.

Reference Type: DERIVED

PMID: 39753245 (View on PubMed)

Other Identifiers

6039808

Identifier Type: -

Identifier Source: org_study_id