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?

This trial tests a new approach called Post-Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS) to aid patients and their families after ICU discharge. The goal is to determine if this support improves patients' quality of life and assists with physical, mental, and daily functioning compared to usual care. It includes health management, rehabilitation, social support, and coordinating medical care through telehealth sessions. Candidates may qualify if they have spent over two days in an ICU, are at risk for long-term issues, and are returning home. Participants should be open to regular health check-ins and assessments from home via telehealth. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance recovery for future ICU patients.

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.

What prior data suggests that the PIC-TRFS intervention is safe for patients and families after critical illness?

Research shows that the Post-Intensive Care Transitions, Rehabilitation and Family Support (PIC-TRFS) program helps people after intensive care unit (ICU) stays. This support aims to improve physical, mental, and social well-being. Studies have found that similar programs, such as follow-up clinics and telehealth check-ins, are generally well-received by patients and often lead to benefits like better quality of life and reduced stress.

For the PIC-TRFS program, available data reports no specific negative effects or safety issues. The program includes telehealth sessions and support, which are generally low risk. Since this trial does not test a new drug or medical procedure but rather a support program, the chance of serious side effects is low. Participants can expect a focus on improving health and quality of life with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PIC-TRFS intervention because it offers a comprehensive approach to post-intensive care recovery that isn't typically part of standard care. Unlike traditional treatments that might focus solely on medical management, PIC-TRFS integrates four key elements: rehabilitation, health and symptom management, social support, and healthcare coordination. This holistic method is delivered by a specialized intervention team and utilizes telehealth, making it accessible for patients and their families during the critical transition from hospital to home. By partnering with survivors, families, and usual care teams, this approach aims to improve long-term outcomes and quality of life after critical illness.

What evidence suggests that the PIC-TRFS intervention is effective for improving outcomes after critical illness?

Studies have shown that transitional care programs, such as PIC-TRFS, aid recovery from the physical, mental, and cognitive challenges faced after an ICU stay. In this trial, some participants will receive the PIC-TRFS intervention, which includes health management, rehabilitation, social support, and care coordination. Research indicates that these programs may enhance the quality of life and daily functioning for patients and their families. Early evidence suggests that PIC-TRFS may increase the number of days patients spend at home following intensive care. Additionally, these programs are linked to better management of trauma symptoms, which often occur after serious illness. Overall, this approach shows promise for improving life after an ICU stay. ^{1 2 3 4 6}

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

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-caregiver-burden-8-2024-2de65

Transitional Care and Support for Critical Illness (PIC-TRFS Trial) Research shows that transitional care interventions started in the ICU can help with recovery from post-intensive care syndrome (PICS), which includes physical, ...

2. jintensivecare.biomedcentral.com jintensivecare.biomedcentral.com/articles/10.1186/s40560-023-00716-w

Post-intensive care syndrome follow-up system after hospital ... The PICS follow-up system includes a PICS follow-up clinic, home visitations, telephone or mail follow-ups, and telemedicine.

3. clinicaltrial.be clinicaltrial.be/en/details/442439?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Post-Intensive Care Transitional Care, Rehabilitation, an... Specifically, this research will test whether PIC-TRFS improves survivor quality of life, days alive at home, function, trauma symptoms, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06501365

Post-Intensive Care Transitional Care, Rehabilitation, and ... The goal of this randomized control trial is to test an intervention designed to improve patient and family outcomes after critical illness compared to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10879727/

Post‐intensive care syndrome: Recent advances and future ... Post‐intensive care syndrome comprises physical, cognitive, and mental impairments in patients treated in an intensive care unit (ICU).

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jan.16995

Post‐Intensive Care Syndrome: A Growing and Under‐ ... Sharing information about PICS during care transitions ensures that all members of the care team are aware of the patient's needs and contribute ...