Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support

Stopped early · Not applicable

Conditions studied: Intensive Care Unit Syndrome, Disabilities Multiple, Critical Illness, Caregiver Burden

In brief

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.

Key facts

Study ID: NCT06501365
Run by: University of Pittsburgh
People needed: 2
Starts: 2025-08-04
Expected to finish: 2026-07-15
Last updated by the study team: 2026-07-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In order to be eligible to participate in this study, a patient must meet all of the following criteria:
All genders; Age ≥ 50
Admission to the hospital from home/independent living
Receive treatment in an ICU for ≥ 48 hours
At least some risk of ongoing functional impairment, measured as Activity Measures for Post-Acute Care (AMPAC) < 24, Highest Level Mobility (HLM) < 8, Intensive Care Delirium Screening Checklist (ICDSC) > 2, Significant mental health impairment (major depression, generalized anxiety, PTSD, substance use disorder)
Provider or e-prognosis that they are reasonably likely to be alive in 12 months (answers no to "Would you be surprised if this person were alive in 12 months?' or eprognosis risk of 1-year mortality <= 35%
Willingness to adhere to the PIC-TRFS regimen.
Provision of signed and dated informed consent form
In order to be eligible to participate in this study, a family caregiver must meet all of the following criteria:
All genders; Age ≥ 18 years old
In the survivor's social network
Planning to provide at least some in-home support for the survivor after discharge
Willingness to adhere to the PIC-TRFS regimen
Provision of signed and dated informed consent form
In order to be eligible for randomization, dyads must meet all of the following criteria:
Completion of at least the following elements of the Run-In:
Patient: demographics, social needs screening tool, symptom bother scale, brief health literacy screening tool, past medical history, baseline function (Katz, Lawton, and caregiver-reported IQCODE), health priorities \& goals, discharge information
Caregiver: demographics, social needs screening tool, caregiver needs screening, brief health literacy screening, family caregiver training
Discharge to home/independent living

You may not qualify if…

Survivors will be excluded if any of the following apply:
They lack a family caregiver willing to participate;
They have a chronic condition for which they are already receiving dedicated transitional care services (e.g., post-cardiac arrest, transplant, TAVR, etc)
They have chronic functional dependency without potential to increase participation in meaningful activity
They reside outside of Pennsylvania (interventionists are only licensed to practice here)
They are unable to participate in English
A family caregiver who meets any of the following criteria will be excluded from participation in this study:
They are unable to participate in English

Where it is running

UPMC/University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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