Follow-Up Care for Critical Illness

(IMPACT-ICU Trial)

Overseen By Natasha A Jawa, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Queen's University

Disqualifiers: Neurological, Communication, English, Consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 3 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

\~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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ICU Follow-Up Clinics, Post-ICU Recovery Clinics, ICU Survivor Clinics, PICS Management Clinics?

Research suggests that ICU follow-up clinics may help improve the health and quality of life for patients who have been in intensive care, as they often face challenges like physical and mental difficulties after their stay. However, there is still limited evidence on how effective these clinics are, and more studies are needed to confirm their benefits. ^{1 2 3 4 5}

Is follow-up care after critical illness safe for humans?

The research does not provide specific safety data for follow-up care after critical illness, but these clinics are designed to help ICU survivors with physical, cognitive, and mental recovery, suggesting they are generally considered safe. ^{1 2 4 5 6}

How is the ICU Follow-Up Clinic treatment different from other treatments for post-intensive care syndrome (PICS)?

ICU Follow-Up Clinics are unique because they provide a comprehensive, multidisciplinary approach to address the physical, cognitive, and mental health challenges faced by ICU survivors, known as post-intensive care syndrome (PICS). Unlike standard treatments, these clinics are tailored to the specific needs of ICU survivors and involve a variety of interventions and support services to improve long-term recovery. ^{1 4 5 6 7}

Eligibility Criteria

This trial is for ICU survivors who have experienced issues like delirium or difficulty weaning from medical support, as well as their caregivers. It's designed to help those dealing with long-term cognitive, physical, and psychiatric impairments after ICU discharge.

Inclusion Criteria

I am an adult who stayed in the ICU for 4 or more days or needed a ventilator and my doctor thinks I will live 6 more months or longer.

I am an adult caregiver for someone who survived ICU.

Exclusion Criteria

I can speak and read English and have no major neurological or communication issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive specialized follow-up care at 1- and 3-months following ICU discharge, including informational packages and diaries for journaling experiences.

3 months

2 visits (in-person) at 1- and 3-months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-, 3-, and 6-months.

6 months

3 visits (in-person) at 1-, 3-, and 6-months

Qualitative Assessment

Focus groups are conducted to assess the qualitative impact of the intervention on patients and caregivers.

6 months

Treatment Details

Interventions

• ICU Follow-Up Clinics

Trial Overview The study tests if follow-up clinics for ICU survivors can improve their long-term health compared to the usual care after leaving the hospital. The focus is on bettering both clinical outcomes and quality of life for patients and caregivers.

Participant Groups

Group I: Intervention Experimental Treatment 1 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 II: Control Active Control 1 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.

ICU Follow-Up Clinics is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Post-ICU Recovery Clinics for:

• Post-intensive care syndrome (PICS) management
• Long-term cognitive, physical, and psychiatric impairments in ICU survivors and caregivers

Approved in European Union as ICU Follow-Up Clinics for:

• PICS management
• Caregiver support and psychosocial effects mitigation

Approved in Canada as PICS Management Clinics for:

• Long-term cognitive, physical, and psychiatric impairments in ICU survivors and caregivers
• PICS management

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Queen's University

Lead Sponsor

Kingston Health Sciences Centre

Lead Sponsor

Trials

312

Recruited

112,000+

Findings from Research

The PINA study is a pilot randomized controlled trial involving 100 ICU patients aimed at evaluating the feasibility and potential efficacy of a follow-up clinic designed to support ICU survivors suffering from post-intensive care syndrome (PICS).

The intervention includes providing information, consultations, and networking support to improve health-related quality of life (HRQOL) for patients, with outcomes assessed at 6 months post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. Rohr, M., Brandstetter, S., Bernardi, C., et al.[2021]

The project aims to standardize follow-up care for ICU patients at risk of post-intensive care syndrome (PICS) by establishing clear outcome variables and assessment tools, based on a comprehensive literature review and expert collaboration.

The recommendations include guidelines on the frequency of follow-up visits, the healthcare professionals involved, and validated assessment tools in Spanish, which will help in the early detection and management of long-term complications after ICU discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up program after intensive care unit discharge. Busico, M., das Neves, A., Carini, F., et al.[2021]

ICU survivor follow-up clinics are becoming increasingly important as more patients survive intensive care, but the effectiveness of the interventions provided in these clinics is still not well understood, based on a review of 33 reports.

The strongest evidence supports the use of prospective diaries to help prevent or improve psychological symptoms in ICU survivors, while other interventions lack robust support, highlighting a need for more research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes. Lasiter, S., Oles, SK., Mundell, J., et al.[2018]

Healthcare providers recognize the need for a specialized follow-up clinic for intensive care unit survivors to address the complex cognitive, physical, and mental impairments associated with post-intensive care syndrome (PICS).

The proposed clinic model emphasizes a multidisciplinary approach, combining diagnostics and targeted referrals to specialists, although there is some disagreement on the specifics of implementing the referral system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences, opinions and expectations of health care providers towards an intensive care unit follow-up clinic: Qualitative study and online survey. Rohr, M., Weiß, A., Bein, T., et al.[2021]

A systematic review of five studies involving 1707 ICU survivors found that follow-up services may have little to no impact on health-related quality of life (HRQoL) and all-cause mortality up to 12 months after ICU discharge, indicating limited efficacy in addressing post-intensive care syndrome (PICS).

The evidence regarding the effectiveness of ICU follow-up services in reducing depression, anxiety, PTSD, and improving physical and cognitive function is very low, highlighting the need for more robust studies to determine the best approaches for supporting ICU survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up services for improving long-term outcomes in intensive care unit (ICU) survivors. Schofield-Robinson, OJ., Lewis, SR., Smith, AF., et al.[2023]

Intensive care unit follow-up clinics are essential for helping survivors of critical illness recover from post-intensive care syndrome, addressing their physical, cognitive, psychiatric, and social needs.

Successfully establishing these clinics requires overcoming challenges such as securing adequate resources, assembling a dedicated multidisciplinary team, and effectively identifying patients who will benefit from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting the Challenges of Establishing Intensive Care Unit Follow-up Clinics. Butcher, BW., Eaton, TL., Montgomery-Yates, AA., et al.[2023]

A study of 12,862 ICU survivors found that nearly half (46.2%) experienced unplanned readmission or death within a year after discharge, highlighting the need for effective follow-up care.

The developed risk score can identify high-risk patients based on factors like pre-existing mental health disorders and the severity of critical illness, allowing for targeted referrals to follow-up services to potentially improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a risk score to predict unplanned hospital readmissions in ICU survivors: A data linkage study. Pilowsky, JK., von Huben, A., Elliott, R., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

Follow-up program after intensive care unit discharge. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Experiences, opinions and expectations of health care providers towards an intensive care unit follow-up clinic: Qualitative study and online survey. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Follow-up services for improving long-term outcomes in intensive care unit (ICU) survivors. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Meeting the Challenges of Establishing Intensive Care Unit Follow-up Clinics. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Development and validation of a risk score to predict unplanned hospital readmissions in ICU survivors: A data linkage study. [2023]