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

NCT ID: NCT06501365

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2029-12-31

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.

Conditions

Intensive Care Unit Syndrome; Disabilities Multiple; Critical Illness; Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

PIC-TRFS Intervention

Post-Intensive Care Transitions, Rehabilitation and Family Support (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.

Group Type: EXPERIMENTAL

Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care Control

Intervention Type: OTHER

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

Interventions

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 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.

Intervention Type: OTHER

Enhanced Usual Care Control

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

Intervention Type: OTHER

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, Intensive Care Delirium Screening Checklist (ICDSC) > 2, Significant mental health impairment (major depression, generalized anxiety, PTSD, substance use disorder)

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. Willingness to adhere to the PIC-TRFS regimen.

7. 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. Willingness to adhere to the PIC-TRFS regimen

5. 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:

1. Patient: demographics, social needs screening tool, symptom bother scale, brief health literacy screening tool, past medical history, baseline function (Katz, Lawton, and caregiver-reported IQCODE), health priorities & goals, discharge information

2. Caregiver: demographics, social needs screening tool, caregiver needs screening, brief health literacy screening, family caregiver training

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)

5. They are unable to participate in English

A family caregiver who meets any of the following criteria will be excluded from participation in this study:

1. They are unable to participate in English

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Leslie Scheunemann

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leslie P Scheunemann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC/University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 38688852 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31726016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30055423 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35473739 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 29280726 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29444624 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31496394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30849004 (View on PubMed)

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.

Reference Type: BACKGROUND

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Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://picturethis.pitt.edu/

Website intended to highlight research and provide a "living toolkit" to survivors and families.

Other Identifiers

R01HS029870-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

STUDY23110156

Identifier Type: -

Identifier Source: org_study_id