Transitional Care and Support for Critical Illness

(PIC-TRFS Trial)

Overseen By Leslie P. Scheunemann, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No caregiver, Transitional care, Dependency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized control trial is to test an intervention designed to improve patient and family outcomes after critical illness compared to usual care. The intervention, called Post-Intensive Care Transitions, Rehabilitation and Family Support (PIC-TRFS) combines four elements: (1) health management; (2) rehabilitation; (3) social support; (4) care coordination. All patients and families enrolled in this study will have spent at least 48 hours in an ICU, be at risk for long-term functional impairment, and be discharged home. Although age of the patients will be restricted to those who are at least 50 years old and caregivers must be adults over 18 and all participants must speak English, the study will enroll all sexes, genders, races, and ethnicities. The main questions the study aims to answer are: 1. Compared to usual care, does PIC-TRFS improve patient quality of life at the end of the 6-month intervention period measured via PROMIS-Preferences (PROPr) score? 2. Compared to usual care, does PIC-TRFS improve patient physical, cognitive, and psychological functioning measured via PROMIS Physical, Cognitive, and Depression Computer Adaptive Test (CAT) at 6 and 12 months after discharge? Does it increase the number of days survivors spend alive at home in the 6 and 12 months after discharge? Does it improve patient and family trauma scores and dyadic quality of life, measured via the Impact of Events Scale-Revised and dyadic PROPr score? Participants will: * Complete Run-In assessments of symptoms and function in the hospital; * Be randomized to intervention or control; * Complete assessments of their function and quality of life at 0, 3, 6 and 12 months * Control participants will get a brochure on the Post-Intensive Care syndrome and complete the assessments on the same schedule as those receiving the intervention * Intervention participants will complete tele-health based check-ins providing health management, social support, and care coordination; and telehealth-based rehabilitation sessions focusing on patient functioning.

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 is best to discuss this with the trial coordinators or your healthcare provider.

Is the Transitional Care and Support for Critical Illness treatment safe for humans?

The research does not provide specific safety data for the Transitional Care and Support for Critical Illness treatment, but it highlights the importance of early rehabilitation and follow-up care for ICU survivors to address post-intensive care syndrome (PICS), which includes physical, cognitive, and psychological challenges. ^{1 2 3 4 5}

How is the PIC-TRFS treatment different from other treatments for post-intensive care syndrome?

The PIC-TRFS treatment is unique because it focuses on transitional care and support for both patients and their families after a critical illness, involving a multidisciplinary team to address physical, cognitive, and psychological health issues. This approach is distinct from standard treatments as it emphasizes early and continuous rehabilitation starting in the ICU and extending after discharge, aiming to improve overall quality of life and long-term outcomes. ^{1 3 4 5 6}

What data supports the effectiveness of the treatment Post-Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)?

Research shows that transitional care interventions started in the ICU can help with recovery from post-intensive care syndrome (PICS), which includes physical, mental, and cognitive challenges after critical illness. Rehabilitation programs, especially those that are interdisciplinary and home-based, are recognized as important for improving the recovery of ICU survivors. ^{1 4 7 8 9}

Who Is on the Research Team?

Leslie P Scheunemann, MD MPH

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for patients aged 50+ and caregivers over 18 who speak English, have spent at least 48 hours in an ICU, are discharged home, and may face long-term functional impairment. It's open to all sexes, genders, races, and ethnicities.

Inclusion Criteria

I was admitted to the hospital from my home.

I have been treated in an ICU for at least 48 hours.

I am 50 years old or older.

Exclusion Criteria

Survivors: Reside outside of Pennsylvania

Survivors: Have a chronic condition for which they are already receiving dedicated transitional care services

I do not have a family member willing to be involved in my care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-In

Participants complete Run-In assessments of symptoms and function in the hospital

Duration not specified

In-hospital assessments

Treatment

Participants receive the PIC-TRFS intervention or control from discharge until 6 months post-discharge

6 months

Telehealth check-ins and rehabilitation sessions

Follow-up

Participants are monitored for quality of life, cognitive function, and healthcare utilization

6 months

Assessments at 0, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Post-Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)

Trial Overview The study compares a new care approach called PIC-TRFS—combining health management, rehabilitation, social support & care coordination—to usual care for improving life after critical illness. Participants will be randomly assigned to either the intervention or control group.

How Is the Trial Designed?

Group I: PIC-TRFS Intervention Experimental Treatment 1 Intervention

Post-Intensive Care Transitions, Rehabilitation and Family Support (PIC-TRFS) is a complex dyadic intervention consisting of 4 essential elements: (1) rehabilitation; (2) health and symptom management; (3) social support; (4) healthcare coordination. It is delivered by an interventionist team. One trained interventionist leads the healthcare coordination, health and symptom management, and social support. An occupational therapist interventionist leads the rehabilitation. Following a Run-In period in the hospital, the interventionists deliver PIC-TRFS via telehealth from the time of randomization at discharge until 6 months after discharge. This Team partners with survivors, families, and the usual care team to deliver the active ingredients of PIC-TRFS.

Group II: Enhanced Usual Care Control Active Control 1 Intervention

After receiving the Run-In and being randomized to control, this group will receive a brochure on critical illness survivorship, outcome ascertainment on the same schedule as the intervention group, and intervention for serious adverse events (e.g., suicidal ideation) identified during study conduct. This design limits exposure of the control group to the hypothesized essential elements of the PIC-TRFS intervention, while maintaining regular contact to enhance retention and outcomes ascertainment, and addressing safety concerns among participants.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

A multidisciplinary task force developed 12 strong recommendations and 4 therapy options for addressing post-intensive care syndrome (PICS) in ICU survivors, emphasizing the importance of early mobilization, motor training, and nutrition management.

Regular assessments of physical, cognitive, and psychological health are crucial for effectively treating PICS, highlighting the need for individualized rehabilitation strategies tailored to each patient's specific impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. Renner, C., Jeitziner, MM., Albert, M., et al.[2023]

The REACH program, an interdisciplinary home-based rehabilitation intervention for patients with Post-Intensive Care Syndrome (PICS), was found to be feasible and well-received, with 79.1% of participants completing the 6-month follow-up without any adverse events.

Patients in the REACH group reported higher satisfaction and a larger number of visits to allied health professionals compared to those receiving usual care, although both groups showed similar recovery in functional outcomes and health-related quality of life at 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a home-based interdisciplinary rehabilitation program for patients with Post-Intensive Care Syndrome: the REACH study. Major, ME., Dettling-Ihnenfeldt, D., Ramaekers, SPJ., et al.[2023]

Recent pilot studies suggest that innovative rehabilitation strategies can improve recovery for patients who survive critical illnesses, addressing issues related to postintensive care syndrome (PICS).

There is a need for further research with larger sample sizes and better-defined intervention protocols to identify the most effective rehabilitation approaches for patients recovering from critical illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for post ICU rehabilitation. Denehy, L., Elliott, D.[2012]

Survivors of critical illness often experience post-intensive care syndrome (PICS), which includes a range of physical, cognitive, psychological, and existential health issues, highlighting the need for targeted interventions.

Early physical rehabilitation and case management interventions show promise in improving long-term outcomes for ICU survivors, while late interventions have had mixed results, indicating the importance of timely and tailored care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. Brown, SM., Bose, S., Banner-Goodspeed, V., et al.[2020]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

The effects of intensive care unit-initiated transitional care interventions on elements of post-intensive care syndrome: A systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. [2023]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of rehabilitation initiation timing in the intensive care unit on outcomes in patients with pneumonia]. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of a home-based interdisciplinary rehabilitation program for patients with Post-Intensive Care Syndrome: the REACH study. [2023]

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

Strategies for post ICU rehabilitation. [2012]

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

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes from critical care. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Impairments, activity limitations and participation restrictions experienced in the first year following a critical illness: protocol for a systematic review. [2018]

9. France pubmed.ncbi.nlm.nih.gov

[Head trauma patients, towards a new life project]. [2017]