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

Not Applicable

Not yet recruiting

• Conditions: Intensive Care Unit Syndrome; Critical Illness; Caregiver Burden; Disabilities Multiple
• Interventions: Other: Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS); Other: Enhanced Usual Care Control

• Registration Number: NCT06501365
• Lead Sponsor: University of Pittsburgh

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-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.

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 health problems, high healthcare costs, and early death. Gaps in care delivery contribute to poor outcomes and preventable rehospitalizations for both patients and families. In response to these gaps, the study team used community engagement to design an intervention with 4 elements: (1) rehabilitation; (2) health and symptom management; (3) social support; (4) healthcare coordination. The result is the PIC-TRFS, which stands for Post-Intensive Care Transitional care, Rehabilitation, and Family Support (PIC-TRFS).

PIC-TRFS combines in-person and telehealth support delivered by an interdisciplinary team to nimbly address health, rehabilitation, social, and care coordination needs in collaboration with existing hospital, home health, and primary care providers. The PIC-TRFS team follows participants across transitions from hospital to home in the six months following a critical illness hospitalization. This single center randomized control trial will test whether PIC-TRFS improves outcomes compared to Enhanced Usual Care. Specifically, this research will test whether PIC-TRFS improves survivor quality of life, days alive at home, function, trauma symptoms, and family care partner quality of life. It will also test whether PIC-TRFS reduces healthcare utilization, measured as a combination of days in a healthcare facility, Emergency Department visits, and outpatient visits. At the same time, this research will assess how consistently the intervention is delivered to make sure that differences between groups really reflect the impact of the intervention. Finally, the study will explore whether the intervention may reduce health disparities between people with higher health and social needs. Successful conduct of this trial will test whether PIC-TRFS works, generate insight into how it works, and identify its impact on health equity.

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Study Start: 2025-05-26
• Primary Completion: 2028-07-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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, or Intensive Care Delirium Screening Checklist (ICDSC) > 2
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. Able to participate in English
7. Willingness to adhere to the PIC-TRFS regimen.
8. 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. Able to participate in English
5. Willingness to adhere to the PIC-TRFS regimen
6. 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: medication reconciliation, screening for health and social needs, creation of their event calendar, and hands-on education and training addressing key training needs and event calendar use
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)

Further, dyads who initially meet inclusion criteria and enter the Run-In will be disenrolled for two reasons:

1. discharge to a location other than home;
2. failure to complete the required elements of the Run-In.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PIC-TRFS Intervention	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. One trained interventionist leads the healthcare coordination, health and symptom management, and social support. An occupational therapist interventionist leads the rehabilitation. Following a Run-In period in the hospital, the interventionists deliver PIC-TRFS 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.
Enhanced Usual Care Control	Enhanced Usual Care Control	After receiving the Run-In and being randomized to control, this group will receive a brochure on critical illness survivorship, outcome ascertainment on the same schedule as the intervention group, and intervention for serious adverse events (e.g., suicidal ideation) identified during study conduct. This design limits exposure of the control group to the hypothesized essential elements of the PIC-TRFS intervention, while maintaining regular contact to enhance retention and outcomes ascertainment, and addressing safety concerns among participants.

Primary Outcome Measures

Name	Time	Method
Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period	6 months	Patients will report health-related quality of life using Patient Reported Outcomes Measurement Information System (PROMIS) surveys in 7 domains: physical, cognitive, mental health, social role satisfaction, pain, fatigue, and sleep. The statistician will use the surveys to calculate a PROMIS-Preferences (PROPr) score using the code available here https://www.proprscore.com/code-and-data/ . This yields a T-score with a minimum of -0.022 (worse than dead) and a maximum score of 1 (maximum quality of life). These scores will be aggregated by calculating the mean for each study group.

Secondary Outcome Measures

Name	Time	Method
Between-group difference in patient PROMIS-Preferences scores at the end of the study period	12 months	Patients will report health-related quality of life using PROMIS surveys in 7 domains: physical, cognitive, mental health, social role satisfaction, pain, fatigue, and sleep. The statistician will use the surveys to calculate a PROPr score using the code available here https://www.proprscore.com/code-and-data/ . This yields a T-score with a minimum of -0.022 (worse than dead) and a maximum score of 1 (maximum quality of life). These scores will be aggregated by calculating the mean for each study group.
Between group differences in survivor physical function	6 and 12 months	Patients will complete the PROMIS Physical Function Computer Adaptive Test (CAT) survey. This yields a T-score with a mean score of 50 and SD of 10, with scores of 0 representing the worst possible physical function and scores of 100 the best possible physical function. Means for each study group will be compared.
Between group differences in survivor cognitive function	6 and 12 months	Patients will complete the PROMIS Cognitive Function Computer Adaptive Test (CAT) survey. This yields a T-score with a mean score of 50 and SD of 10, with scores of 0 representing the worst possible cognitive function and scores of 100 the best possible cognitive function. Means for each study group will be compared.
Between group differences in survivor mood	6 and 12 months	Patients will complete the PROMIS Mood (Depression) CAT survey. This yields a T-score with a mean score of 50 and SD of 10, with scores of 0 representing the worst possible mood function and scores of 100 the best possible mood. Means for each study group will be compared.
Between-group differences in mean dyadic PROMIS-Preferences (PROPr) Scores	6 and 12 months	Patients and families will report health-related quality of life using PROMIS surveys in 7 domains: physical, cognitive, mental health, social role satisfaction, pain, fatigue, and sleep. The statistician will use the surveys to calculate a PROPr score using the code available here https://www.proprscore.com/code-and-data/ . This yields a T-score with a minimum of -0.022 (worse than dead) and a maximum score of 1 (maximum quality of life). These scores will be aggregated by adding the values of each patient-family dyad and then calculating the mean for each study group.
Between group differences in dyadic trauma symptoms	6 and 12 months	Patients and families will complete the Impact of Events Scale-Revised. Individual scores range from 0-88, with scores \>=24 indicating clinical concern for Post Traumatic Stress Disorder (PTSD), scores \>=33 indicating probably PTSD, and scores \>=37 indicating severe PTSD. The statistician will sum the scores of the patient-family dyad. Assuming a normal distribution, they will compare means for each study group.
Between group differences in survivor days alive at home.	6 and 12 months	Survivor days alive at home at home will be measured from the time of discharge to the specified time point (6 and 12 months) post discharge. Family, primary care provider, or death certificate will confirm date of death. Days in a healthcare facility (Emergency Department, hospital or skilled nursing facility) will be self-reported via an Event Calendar. Days alive at home will be calculated by subtracting the sum of days in a healthcare facility and days dead over 6 and 12 months after discharge, respectively. Medians for each study group will be compared. Minimum value is 0 (readmitted or died on the day of discharge) and maximum is 365 (survived the year without readmission).
Between group differences in survivor Healthcare Utilization	6 and 12 months	Healthcare facility days and Emergency Department visits, both individually and collectively, will be extracted from: (a) patient and family report via event calendar; (b) medical record review. The statistician will sum the number of healthcare facility days and Emergency Department visits. Medians for each study group will be compared. Minimum value is 0 (no healthcare utilization, probably an indicator of extremely poor health or lack of access); a low number utilized is consistent with stable health with access (\~1-12); while high utilization (\>12) likely indicates unstable health with consequently high needs

Trial Locations

Locations (1)

UPMC/University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States