Status:
RECRUITING
Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Intensive Care Unit Syndrome
Disabilities Multiple
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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-Intens...
Detailed Description
Each year in the United States, over 3 million people survive critical illness only to experience long-term physical, cognitive, and psychological functional impairments that contribute to ongoing hea...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria
- 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:
- 1\. They are unable to participate in English
Exclusion
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06501365
Start Date
August 4 2025
End Date
December 31 2029
Last Update
August 27 2025
Active Locations (1)
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1
UPMC/University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213