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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
320
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.
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
UPMC/University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period
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.
Time frame: 6 months
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.
Time frame: 12 months
Between group differences in survivor physical function
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.
Time frame: 6 and 12 months
Between group differences in survivor cognitive function
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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 (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).
Time frame: 6 and 12 months
Between group differences in survivor Healthcare Utilization
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
Time frame: 6 and 12 months
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