Transitional Care and Support for Critical Illness
(PIC-TRFS Trial)
Trial Summary
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 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.12345
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.12678
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.12789
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.
Research Team
Leslie P Scheunemann, MD MPH
Principal Investigator
University of Pittsburgh
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-In
Participants complete Run-In assessments of symptoms and function in the hospital
Treatment
Participants receive the PIC-TRFS intervention or control from discharge until 6 months post-discharge
Follow-up
Participants are monitored for quality of life, cognitive function, and healthcare utilization
Treatment Details
Interventions
- Post-Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator