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

NCT06681649 | Recruiting

• 1 other identifier: 6039808
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

critical illness; delirium; post-intensive care syndrome

Outcome Measures

Primary Outcomes (5)

• Feasibility - Consent Rate

  To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measure: Consent rate, measured as the proportion of eligible population who consent to participate

  6 months

• Feasibility - Enrolment Rate

  To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Enrolment rate, measured as the proportion of consented participants who are randomized

  6 months

• Feasibility - Follow-Up Rate

  To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Follow-up rate, measured as the proportion of enrolled participants who complete follow-up visits at 1-, 3-, and 6-months

  6 months

• Feasibility - Data Capture Rate

  To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Data capture rate, measured as the percentage of data elements acquired at each study time point

  6 months

• Feasibility - Rate of adverse events

  To determine the feasibility of a pragmatic RCT evaluating the impact of a post-ICU follow-up clinic intervention on clinical and qualitative patient and caregiver outcomes, as assessed via the following measures: Rate of adverse events, assessed using the number of hospital and ICU readmissions, as well as the number of visits to the emergency department at 6 months.

  6 months

Secondary Outcomes (2)

• Qualitative impact of intervention

  6 months

• Process evaluation

  6 months

Other Outcomes (14)

• Neurocognition

  6 months

• Weight and BMI

  6 months

• Clinical Outcome

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Intervention

Control

NO INTERVENTION

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 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 39753245 DERIVED

MeSH Terms

Conditions

Critical Illness; Delirium; postintensive care syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

J G Boyd, MD PhD

CONTACT

6135496666 x6228; gordon.boyd@kingstonhsc.ca

Natasha A Jawa, MSc

CONTACT

tasha.jawa@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 8, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

CA (1)