100 Participants Needed

PICTURE-THIS Intervention for Post Intensive Care Recovery

LP
Overseen ByLeslie P Scheunemann, MD MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the PICTURE-THIS treatment for post-intensive care recovery?

Research on post-intensive care syndrome (PICS) highlights the importance of rehabilitation strategies to help patients recover from physical, mental, and cognitive challenges after critical illness. While specific data on PICTURE-THIS is not available, similar multimodal rehabilitation approaches have been shown to aid recovery in ICU survivors.12345

How is the PICTURE-THIS treatment different from other treatments for post-intensive care syndrome?

The PICTURE-THIS treatment is unique because it focuses on a comprehensive approach to recovery, addressing physical, mental, and cognitive impairments that often occur after intensive care. Unlike standard treatments that may focus on one aspect, this intervention aims to provide a holistic rehabilitation strategy for survivors of critical illness.13467

What is the purpose of this trial?

This is a single-center pilot study examining the feasibility and acceptability of a transitional rehabilitation intervention, PICTURE-THIS, among critical illness survivors and their families. The intervention activities include transitional care coordination and activity-based rehabilitation delivered by a specialist team and integrated into usual care. There are three components to the assessment of feasibility and acceptability in this study:1. User testing the PICTURE-THIS protocol to work out basic challenges to feasibility and acceptability.2. Assessing the feasibility and acceptability of the user-tested PICTURE-THIS protocol.3. Assessing the feasibility and acceptability of research activities required to test the clinical efficacy of PICTURE-THIS to improve outcomes among critical illness survivors and their family caregivers.

Research Team

LP

Leslie P Scheunemann, MD MPH

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for critical illness survivors over 50 who spent at least 48 hours in ICU, have a life expectancy of over a year, and were admitted from home. It's also for their caregivers aged 21+, who've been supporting since the ICU stay. Healthcare providers involved with these pairs can join too. All participants must speak English and live in Pennsylvania.

Inclusion Criteria

I am 50 years old or older.
You have an expected prognosis of 12 months or more.
I am willing to fill out a survey.
See 6 more

Exclusion Criteria

Patients: No identified caregiver
I cannot participate in activities in English.
resides outside of Pennsylvania

Timeline

Run-In Phase

Initial phase in the hospital to prepare participants for the intervention

Not specified

Post-Discharge Phase

Outpatient transitional care management and activity-based rehabilitation

3 months
Up to 8 transitional care visits and 10 rehabilitation visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Outcome assessments at discharge, 3 and 6 months

Treatment Details

Interventions

  • PICTURE-THIS
Trial Overview The study tests PICTURE-THIS, an intervention combining transitional care coordination with activity-based rehabilitation by specialists, to see if it's feasible and acceptable for patients post-critical care and their families.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: PICTURE-THIS servicesExperimental Treatment2 Interventions
This group receives a Run-In Phase followed by outpatient transitional care management (up to 8 visits over 3 months), activity-based rehabilitation (up to 10 visits over 3 months), and social support for patients and families (ongoing screening and referral). They will also undergo outcome assessments at discharge, 3 and 6 months.
Group II: Enhanced Usual CareActive Control2 Interventions
Enhanced Usual Care (EUC) control group will rececive a Run-in Phase followed by an informational brochure with regular assessments on the same schedule as the PICTURE-THIS group (i.e., discharge, 3 and 6 months)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials
415
Recruited
6,777,000+

Findings from Research

Recent pilot studies suggest that innovative rehabilitation strategies can improve recovery for patients who survive critical illnesses, addressing issues related to postintensive care syndrome (PICS).
There is a need for further research with larger sample sizes and better-defined intervention protocols to identify the most effective rehabilitation approaches for patients recovering from critical illnesses.
Strategies for post ICU rehabilitation.Denehy, L., Elliott, D.[2012]
The study successfully assessed cognitive and sensorimotor function in ICU patients at 3 and 12 months post-discharge, revealing that a significant portion of participants exhibited impairments in visuospatial skills (54% at 3 months and 32% at 12 months).
Despite the feasibility of the multimodal data collection strategy, retention of participants was a challenge, with only 40% returning at 3 months and 31% at 12 months, indicating a need for improved strategies to encourage follow-up participation.
Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study.Wood, MD., Maslove, DM., Muscedere, J., et al.[2019]
A multidisciplinary task force developed 12 strong recommendations and 4 therapy options for addressing post-intensive care syndrome (PICS) in ICU survivors, emphasizing the importance of early mobilization, motor training, and nutrition management.
Regular assessments of physical, cognitive, and psychological health are crucial for effectively treating PICS, highlighting the need for individualized rehabilitation strategies tailored to each patient's specific impairments.
Guideline on multimodal rehabilitation for patients with post-intensive care syndrome.Renner, C., Jeitziner, MM., Albert, M., et al.[2023]

References

Strategies for post ICU rehabilitation. [2012]
Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. [2019]
Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. [2023]
Post-intensive care syndrome: impact, prevention, and management. [2020]
Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test. [2022]
Physical Impairments Associated With Post-Intensive Care Syndrome: Systematic Review Based on the World Health Organization's International Classification of Functioning, Disability and Health Framework. [2019]
Frequency and risk factors of post-intensive care syndrome components in a multicenter randomized controlled trial of German sepsis survivors. [2021]
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