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NCT06501365

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

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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-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.

Official title: Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support RCT

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-04

Completion Date

2026-07-15

Last Updated

2026-07-27

Healthy Volunteers

Conditions

Intensive Care Unit Syndrome Disabilities Multiple Critical Illness Caregiver Burden

Interventions

OTHER

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

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 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.

OTHER

Enhanced Usual Care Control

Dyads randomized to the Control group will receive: (1) the Run-In; (2) an informational brochure on the post-Intensive Care Syndrome; (3) ongoing assessments on the same schedule as the PIC-TRFS intervention; (4) referral for urgent emergent issues identified during the study

Inclusion Criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: 1. All genders; Age ≥ 50 2. Admission to the hospital from home/independent living 3. Receive treatment in an ICU for ≥ 48 hours 4. 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) 5. 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% 6. Willingness to adhere to the PIC-TRFS regimen. 7. 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: 1. All genders; Age ≥ 18 years old 2. In the survivor's social network 3. Planning to provide at least some in-home support for the survivor after discharge 4. Willingness to adhere to the PIC-TRFS regimen 5. Provision of signed and dated informed consent form In order to be eligible for randomization, dyads must meet all of the following criteria: 1. Completion of at least the following elements of the Run-In: 1. 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 2. Caregiver: demographics, social needs screening tool, caregiver needs screening, brief health literacy screening, family caregiver training 2. Discharge to home/independent living Exclusion criteria Survivors will be excluded if any of the following apply: 1. They lack a family caregiver willing to participate; 2. They have a chronic condition for which they are already receiving dedicated transitional care services (e.g., post-cardiac arrest, transplant, TAVR, etc) 3. They have chronic functional dependency without potential to increase participation in meaningful activity 4. They reside outside of Pennsylvania (interventionists are only licensed to practice here) 5. 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

Locations (1)

UPMC/University of Pittsburgh

Pittsburgh, Pennsylvania, United States