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

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

~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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Delirium in the Intensive Care Unit
• Intervention / Treatment: Behavioral: Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: J G Boyd, MD PhD; Phone Number: 6228 6135496666 x6228; Email: gordon.boyd@kingstonhsc.ca
• Study Contact Backup: Name: Natasha A Jawa, MSc; Email: tasha.jawa@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Queen's University
      • Contact: Gordon Boyd, MD PhD FRCPC; Phone Number: 6135392754; Email: gordon.boyd@kingstonhsc.ca
      • Contact: J G Boyd, MD PhD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative impact of intervention	To determine the qualitative impact of a post-ICU follow-up care intervention on patients and caregivers, as assessed via qualitative analysis of focus group discussions.	6 months
Process evaluation	To perform a process evaluation of the multimodal ICU follow-up bundle of care intervention to understand the implementation, acceptability, content, barriers, and facilitators to use of diaries, informational materials, and the follow-up clinic.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognition	Neurocognitive outcomes, as measured using the MoCA	6 months
Weight and BMI	To determine the effect of a post-ICU follow-up clinic intervention on changes in weight and body-mass index (BMI) following ICU discharge	6 months
Clinical Outcome	Frailty, as measured using the CFS	6 months
Quality of Life	Quality of life outcomes, as measured using the SF-36	6 months
Anxiety and mood	Anxiety and depression, as measured using the HADS	6 months
Post-traumatic stress	PTSD, as measured using the PTSS-14	6 months
Chronic pain	Chronic pain, as measured using the Chronic Pain Grade Scale (CPGS)	6 months
Fatigue	Chronic fatigue, as measured using the Fatigue Severity Scale (FSS)	6 months
Activities of daily living	Activities of daily living (ADLs), as measured using the Katz Index of ADLs	6 months
Instrumental activities of daily living	Instrumental ADLs, as measured using the Lawton IADL score	6 months
Physical function	Lower extremity strength, as measured using the 30-second Sit-to-Stand Test	6 months
Resiliency	Dyadic resiliency among ICU survivors and caregivers, as measured using the dyadic Connor-Davidson 10-item Resiliency Scale (CD-RISC-10)	6 months
Return to work	To determine the effect of a post-ICU follow-up clinic intervention on return to work by ICU survivors	6 months
Employment status of caregivers	Employment status relative to previous among caregivers	6 months

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: delirium; critical illness; post-intensive care syndrome
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Critical Illness
• Other Study ID Numbers: 6039808

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No