Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support
NCT Number: NCT06501365
Acronym: PIC-TRFS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intensive Care Unit Syndrome|Disabilities Multiple|Critical Illness|Caregiver Burden
Interventions: OTHER: Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)|OTHER: Enhanced Usual Care Control
Sponsor: University of Pittsburgh
Collaborators: Agency for Healthcare Research and Quality (AHRQ)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 320
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-01
Completion Date: 2029-04-30
Locations: UPMC/University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States

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 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 ocmplete 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.

Primary Outcome Measures: Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period, 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., 6 months
Secondary Outcome Measures: Between-group difference in patient PROMIS-Preferences scores at the end of the study period, 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., 12 months|Between group differences in survivor physical function, Patients will complete the PROMIS Physical Function 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., 6 and 12 months|Between group differences in survivor cognitive function, Patients will complete the PROMIS Cognitive Function 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., 6 and 12 months|Between group differences in survivor mood, 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., 6 and 12 months|Between-group differences in mean dyadic PROMIS-Preferences (PROPr) Scores, 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., 6 and 12 months|Between group differences in dyadic trauma symptoms, Patients and families will complete the Impact of Events Scale-Revised. Individual scores range from 0-88, with scores \>=24 indicating clinical concern for 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., 6 and 12 months|Between group differences in survivor days alive at home., 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 (ED, 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)., 6 and 12 months|Between group differences in survivor Healthcare Utilization, Healthcare facility days and ED 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 ED 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, 6 and 12 months