RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Intensive Care Unit Syndrome
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC/University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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
  • 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
  • 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
  • 1. They are unable to participate in English

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Leslie P Scheunemann, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2029-12-31