Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501365
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-01
Brief Title:
Post-Intensive Care Transitional Care Rehabilitation and Family-Support
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Post-Intensive Care Transitional Care Rehabilitation and Family-Support RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIC-TRFS
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 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
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
Detailed Description:
Each year in the US 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 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 ED 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
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 ED 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HS029870-01 | AHRQ | None | None |