Clinical trial NCT06501365: Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support
Official title: Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intensive Care Unit Syndrome
Disabilities Multiple
Critical Illness
Caregiver Burden
Keywords: Transitional Care
Health Services
Critical Care
Post Intensive Care Unit Syndrome (PICS)
Family Caregiver Support
Post Intensive Care Unit Syndrome Family (PICS - F)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-07-15
Enrollment: 320
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period
timeFrame: 6 months
Secondary outcomes:
measure: Between-group difference in patient PROMIS-Preferences scores at the end of the study period
timeFrame: 12 months
measure: Between group differences in survivor physical function
timeFrame: 6 and 12 months
measure: Between group differences in survivor cognitive function
timeFrame: 6 and 12 months
measure: Between group differences in survivor mood
timeFrame: 6 and 12 months
measure: Between-group differences in mean dyadic PROMIS-Preferences (PROPr) Scores
timeFrame: 6 and 12 months
measure: Between group differences in dyadic trauma symptoms
timeFrame: 6 and 12 months
measure: Between group differences in survivor days alive at home.
timeFrame: 6 and 12 months
measure: Between group differences in survivor Healthcare Utilization
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC/University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Leslie P Scheunemann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scheunemann LP, Motter EM, Kim SP, Eisenhauer P, Gandhi N, Eaton TL, Girard TD, Reynolds CF, Leland NE. Re-engineering Transitional Care After Critical Illness: A Qualitative Integration of Multiple Perspectives. Under review, 2024.
citation: Moale AC, Motter EM, Eisenhauer P, Gandhi N, Kim SP, Girard TD, Reynolds CF 3rd, Leland NE, Chang JC, Scheunemann LP. Integrating Perspectives on Family Caregiving After Critical Illness: A Qualitative Content Analysis. Am J Crit Care. 2024 May 1;33(3):180-189. doi: 10.4037/ajcc2024309.
citation: Scheunemann LP, White JS, Prinjha S, Hamm ME, Girard TD, Skidmore ER, Reynolds CF 3rd, Leland NE. Post-Intensive Care Unit Care. A Qualitative Analysis of Patient Priorities and Implications for Redesign. Ann Am Thorac Soc. 2020 Feb;17(2):221-228. doi: 10.1513/AnnalsATS.201904-332OC.
citation: Naylor MD, Hirschman KB, Toles MP, Jarrin OF, Shaid E, Pauly MV. Adaptations of the evidence-based Transitional Care Model in the U.S. Soc Sci Med. 2018 Sep;213:28-36. doi: 10.1016/j.socscimed.2018.07.023. Epub 2018 Jul 17.
citation: Scheunemann L, White JS, Prinjha S, Eaton TL, Hamm M, Girard TD, Reynolds C, Leland N, Skidmore ER. Barriers and facilitators to resuming meaningful daily activities among critical illness survivors in the UK: a qualitative content analysis. BMJ Open. 2022 Apr 26;12(4):e050592. doi: 10.1136/bmjopen-2021-050592.
citation: Skidmore ER, Butters M, Whyte E, Grattan E, Shen J, Terhorst L. Guided Training Relative to Direct Skill Training for Individuals With Cognitive Impairments After Stroke: A Pilot Randomized Trial. Arch Phys Med Rehabil. 2017 Apr;98(4):673-680. doi: 10.1016/j.apmr.2016.10.004. Epub 2016 Oct 26.
citation: Skidmore ER, Swafford M, Juengst SB, Terhorst L. Self-Awareness and Recovery of Independence With Strategy Training. Am J Occup Ther. 2018 Jan/Feb;72(1):7201345010p1-7201345010p5. doi: 10.5014/ajot.2018.023556.
citation: Rouch S, Skidmore ER. Examining Guided and Directed Cues in Strategy Training and Usual Rehabilitation. OTJR (Thorofare N J). 2018 Jul;38(3):151-156. doi: 10.1177/1539449218758618. Epub 2018 Feb 15.
citation: Campbell GB, Boisen MM, Hand LC, Lee YJ, Lersch N, Roberge MC, Suchonic B, Thomas TH, Donovan HS. Integrating Family Caregiver Support Into a Gynecologic Oncology Practice: An ASCO Quality Training Program Project. JCO Oncol Pract. 2020 Mar;16(3):e264-e270. doi: 10.1200/JOP.19.00409. Epub 2019 Sep 7.
citation: Hand LC, Thomas TH, Belcher S, Campbell G, Lee YJ, Roberge M, Donovan HS. Defining Essential Elements of Caregiver Support in Gynecologic Cancers Using the Modified Delphi Method. J Oncol Pract. 2019 Apr;15(4):e369-e381. doi: 10.1200/JOP.18.00420. Epub 2019 Mar 8.
citation: Chi Y, Thaker K, He D, Hui V, Donovan H, Brusilovsky P, Lee YJ. Knowledge Acquisition and Social Support in Online Health Communities: Analysis of an Online Ovarian Cancer Community. JMIR Cancer. 2022 Sep 13;8(3):e39643. doi: 10.2196/39643.