SUSPENDED

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

Conditions

Intensive Care Unit Syndrome Disabilities Multiple Critical Illness Caregiver Burden Transitional Care Health Services Critical Care Post Intensive Care Unit Syndrome (PICS)Family Caregiver Support Post Intensive Care Unit Syndrome Family (PICS - F)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-08-04

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06501365

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.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Leslie P Scheunemann, MD, MPH

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC/University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-04

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-08-04

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

Transitional Care
Health Services
Critical Care
Post Intensive Care Unit Syndrome (PICS)
Family Caregiver Support
Post Intensive Care Unit Syndrome Family (PICS - F)

Additional Relevant MeSH Terms

Intensive Care Unit Syndrome
Disabilities Multiple
Critical Illness
Caregiver Burden