Intensive Care Unit SyndromePIC-TRFSNCT06501365

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

A study testing Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS) in people with Intensive Care Unit Syndrome and Disabilities Multiple, run by University of Pittsburgh at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Intensive Care Unit Syndrome, Disabilities Multiple, Critical Illness
What is being tested?: Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2025to 15 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%

Show all 19Show fewer

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:
Completion of at least the following elements of the Run-In:
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
Caregiver: demographics, social needs screening tool, caregiver needs screening, brief health literacy screening, family caregiver training
Discharge to home/independent living

Who cannot join

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:
1. They are unable to participate in English

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC/University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support RCT

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:

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?
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.

Read the 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
Being tested: Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS), Enhanced Usual Care Control
Keywords: Transitional Care, Health Services, Critical Care, Post Intensive Care Unit Syndrome (PICS), Family Caregiver Support, Post Intensive Care Unit Syndrome Family (PICS - F)
Medical subject headings: Critical Illness, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Enhanced Usual Care ControlOther
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

Study groups in NCT06501365
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Enhanced Usual Care Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202515 Jul 2026

First posted15 Jul 2024
Study start4 Aug 2025
Primary completion15 Jul 2026
Study completion15 Jul 2026

Why it stopped: Study was suspended pending AHRQ's continuation decision. AHRQ issued a non-award notice for the continuation period, effective July 15, 2026, citing shifting agency priorities. Study will not resume.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06501365
Sponsor's protocol ID: STUDY23110156
Other IDs: R01HS029870-01
Acronym: PIC-TRFS
Status last verified: Jul 2026
First submitted: 1 Jul 2024
Last updated: 27 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Scientific data that will be preserved and shared are demographical data and medical history. In addition, we will preserve and share self-report data obtained from critical illness survivors and caregivers, and those related to intervention delivery, receipt and enactment. Case report forms used to collect construct the EDC will be preserved and shared. Some data will be extracted from participants' electronic health records. We will also share the data dictionary and codebook.

Publications

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.
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.
PubMed 38688852
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.
PubMed 31726016
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.
PubMed 30055423
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.
PubMed 35473739
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.
PubMed 27794487
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.
PubMed 29280726
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.
PubMed 29444624
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.
PubMed 31496394
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.
PubMed 30849004
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.
PubMed 36099015

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support RCT
ClinicalTrials.gov ID: NCT06501365
Acronym / sponsor ID: PIC-TRFS / STUDY23110156
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)
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was suspended pending AHRQ's continuation decision. AHRQ issued a non-award notice for the continuation period, effective July 15, 2026, citing shifting agency priorities. Study will not resume.
Enrolment: 2 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Agency for Healthcare Research and Quality (AHRQ)
Study start: 4 Aug 2025 (actual)
Primary completion: 15 Jul 2026 (actual)
Study completion: 15 Jul 2026 (actual)
First posted: 15 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?
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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PIC-TRFS Intervention	Experimental	Other: Post Intensive Care Transitions Rehabilitation and Family Support (PIC-TRFS)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.
Enhanced Usual Care Control	Active comparator	Other: Enhanced Usual Care ControlAfter 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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)

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	PIC-TRFS Intervention
Enhanced Usual Care ControlDyads 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	Other	Enhanced Usual Care Control

Primary outcome

Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period
Time frame: 6 months
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.

8 secondary outcomes

Between-group difference in patient PROMIS-Preferences scores at the end of the study period
Time frame: 12 months
Between group differences in survivor physical function
Time frame: 6 and 12 months
Between group differences in survivor cognitive function
Time frame: 6 and 12 months
Between group differences in survivor mood
Time frame: 6 and 12 months
Between-group differences in mean dyadic PROMIS-Preferences (PROPr) Scores
Time frame: 6 and 12 months
Between group differences in dyadic trauma symptoms
Time frame: 6 and 12 months
Between group differences in survivor days alive at home.
Time frame: 6 and 12 months
Between group differences in survivor Healthcare Utilization
Time frame: 6 and 12 months

Results and safety

The study was stopped early (reason given: Study was suspended pending AHRQ's continuation decision. AHRQ issued a non-award notice for the continuation period, effective July 15, 2026, citing shifting agency priorities. Study will not resume.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
BackgroundScheunemann 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: PubMed 38688852Moale 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.
Background: PubMed 31726016Scheunemann 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.
Background: PubMed 30055423Naylor 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.
Background: PubMed 35473739Scheunemann 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.
Background: PubMed 27794487Skidmore 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.
Background: PubMed 29280726Skidmore 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.
Background: PubMed 29444624Rouch 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.
Background: PubMed 31496394Campbell 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.
Background: PubMed 30849004Hand 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.
Background: PubMed 36099015Chi 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.
Website intended to highlight research and provide a "living toolkit" to survivors and families.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Scientific data that will be preserved and shared are demographical data and medical history. In addition, we will preserve and share self-report data obtained from critical illness survivors and caregivers, and those related to intervention delivery, receipt and enactment. Case report forms used to collect construct the EDC will be preserved and shared. Some data will be extracted from participants' electronic health records. We will also share the data dictionary and codebook.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie P Scheunemann, MD, MPH principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06501365, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.