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

NCT06501365 | Suspended

• 2 other identifiers: STUDY23110156R01HS029870-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Critical Illness; Intensive Care Unit Syndrome; Disabilities Multiple; 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (8)

• Between-group difference in patient PROMIS-Preferences scores at the end of the study period

  12 months

• Between group differences in survivor physical function

  6 and 12 months

• Between group differences in survivor cognitive function

  6 and 12 months

• Between group differences in survivor mood

  6 and 12 months

• Between-group differences in mean dyadic PROMIS-Preferences (PROPr) Scores

  6 and 12 months

Study Arms (2)

PIC-TRFS Intervention

EXPERIMENTAL

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.

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

Enhanced Usual Care Control

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care Control

Interventions

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

PIC-TRFS Intervention

Enhanced Usual Care Control 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

Enhanced Usual Care Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a patient must meet all of the following criteria:
• All genders; Age ≥ 50
• Admission to the hospital from home/independent living
• Receive treatment in an ICU for ≥ 48 hours
• 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)
• 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%
• Willingness to adhere to the PIC-TRFS regimen.
• 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:
• All genders; Age ≥ 18 years old
• In the survivor's social network
• Planning to provide at least some in-home support for the survivor after discharge
• Willingness to adhere to the PIC-TRFS regimen
• Provision of signed and dated informed consent form
• In order to be eligible for randomization, dyads must meet all of the following criteria:

You may not qualify if:

• Survivors will be excluded if any of the following apply:
• They lack a family caregiver willing to participate;
• They have a chronic condition for which they are already receiving dedicated transitional care services (e.g., post-cardiac arrest, transplant, TAVR, etc)
• They have chronic functional dependency without potential to increase participation in meaningful activity
• They reside outside of Pennsylvania (interventionists are only licensed to practice here)
• 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:
• \. They are unable to participate in English

Sponsors & Collaborators

• University of Pittsburgh: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UPMC/University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (11)

• 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.

  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.

  PMID: 38688852 BACKGROUND

• 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.

  PMID: 31726016 BACKGROUND

• 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.

  PMID: 30055423 BACKGROUND

• 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.

  PMID: 35473739 BACKGROUND

• 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.

  PMID: 27794487 BACKGROUND

• 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.

  PMID: 29280726 BACKGROUND

• 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.

  PMID: 29444624 BACKGROUND

• 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.

  PMID: 31496394 BACKGROUND

• 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.

  PMID: 30849004 BACKGROUND

• 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.

  PMID: 36099015 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Critical Illness; Caregiver Burden

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Leslie P Scheunemann, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and Interventionists cannot be masked to group assignment. The Principal Investigator will remain masked. While most outcomes are patient-reported, Outcomes Assessors will be trained to remind participants not to disclose their group status during assessments.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 15, 2024
• Study Start: August 4, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be retained for at least 7 years after publication of the results, per institutional policy. The data will be available for sharing during this period.
• Access Criteria: Those willing to access the data should initiate request to the Principal Investigator (PI) Dr. Leslie Scheunemann via email. The PI will discuss the request, purpose and merits with the team of co-investigators, collaborators and consultants. Only de-identified data will be shared. The data will be shared only after an appropriate data use agreement. Once approved, data will be transferred via email or a cloud storage platform such as OneDrive.

Locations

US (1)