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

Queen's University40 enrolled

Overview

\~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.

\~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.

Interventions

InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts