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Behavioural Intervention

Transitional Care and Support for Critical Illness (PIC-TRFS Trial)

N/A

Waitlist Available

Led By Leslie P Scheunemann, MD, MPH

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients: Admission to the hospital from home/independent living

Patients: Receive treatment in an ICU for ≥ 48 hours

Must not have

Survivors: Lack a family caregiver willing to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new program, called PIC-TRFS, to help patients and families after a critical illness. The program includes health management, rehabilitation, social support, and care coordination. Participants

Who is the study for?

This trial is for patients aged 50+ and caregivers over 18 who speak English, have spent at least 48 hours in an ICU, are discharged home, and may face long-term functional impairment. It's open to all sexes, genders, races, and ethnicities.

What is being tested?

The study compares a new care approach called PIC-TRFS—combining health management, rehabilitation, social support & care coordination—to usual care for improving life after critical illness. Participants will be randomly assigned to either the intervention or control group.

What are the potential side effects?

Since this trial involves non-medical interventions like telehealth check-ins and rehabilitation sessions rather than drugs or medical procedures, traditional side effects are not expected. However, there might be indirect effects on stress or fatigue levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted to the hospital from my home.

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I have been treated in an ICU for at least 48 hours.

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I am 50 years old or older.

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I am being discharged to my home or an independent living situation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a family member willing to be involved in my care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Between-group difference in mean patient PROMIS-Preferences at the end of the intervention period

Secondary study objectives

Between group differences in dyadic trauma symptoms

Between group differences in survivor Healthcare Utilization

Between group differences in survivor cognitive function

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PIC-TRFS InterventionExperimental Treatment1 Intervention

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 II: Enhanced Usual Care ControlActive Control1 Intervention

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.

0 / 5Eligibility criteria met