PICTURE-THIS Intervention for Post Intensive Care Recovery

Overseen By Leslie P Scheunemann, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No caregiver, Non-English, Outside Pennsylvania

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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

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.

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

Group I: PICTURE-THIS services Experimental Treatment 2 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 Care Active Control 2 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. Renner, C., Jeitziner, MM., Albert, M., et al.[2023]

Preventing post-intensive care syndrome (PICS) during inpatient care is crucial for improving long-term outcomes for patients who have been in intensive care.

Recognizing PICS in outpatient settings is essential for timely intervention and support, helping patients manage the lasting effects of their intensive care experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-intensive care syndrome: impact, prevention, and management. Colbenson, GA., Johnson, A., Wilson, ME.[2020]

A new two-step outcome measurement instrument set for diagnosing post-intensive care syndrome (PICS) was developed through a consensus process involving 14 medical experts and 17 ICU survivors, aiming to improve the identification of PICS in outpatient care.

The first step involves brief screening tests for mental health, cognition, physical function, and health-related quality of life, which are easy to administer by healthcare professionals, while the second step provides a more detailed assessment if initial screenings indicate potential issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test. Spies, CD., Krampe, H., Paul, N., et al.[2022]

Individuals who survived critical illness and experienced post-intensive care syndrome (PICS) showed significant physical impairments within the first year, affecting their body functions, daily activities, and participation in life.

The review of 15 studies highlighted specific issues such as decreased lung function, reduced muscle strength, and difficulties in performing daily tasks, indicating a comprehensive impact of PICS on recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ohtake, PJ., Lee, AC., Scott, JC., et al.[2019]

In a study of 289 sepsis survivors over 24 months, a significant majority experienced impairments related to post-intensive care syndrome (PICS), with frequencies ranging from 32.9% to 98.6% across different classification models.

The study found that older age and longer ICU stays were linked to higher rates of cognitive impairment, while male gender and older age were associated with dysphagia, indicating specific risk factors for certain PICS components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and risk factors of post-intensive care syndrome components in a multicenter randomized controlled trial of German sepsis survivors. Kosilek, RP., Schmidt, K., Baumeister, SE., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Strategies for post ICU rehabilitation. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Post-intensive care syndrome: impact, prevention, and management. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Frequency and risk factors of post-intensive care syndrome components in a multicenter randomized controlled trial of German sepsis survivors. [2021]