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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new rehabilitation program called PICTURE-THIS to aid recovery after a critical illness. It combines care coordination, physical rehabilitation, and social support. Participants are divided into two groups: one receives the new program, while the other receives enhanced usual care with regular assessments. The trial seeks individuals who have spent at least 48 hours in an ICU and may face ongoing challenges with daily activities. Family members who have supported the patient since their ICU stay can also participate. As an unphased trial, this study provides a unique opportunity to contribute to innovative rehabilitation strategies that could benefit future patients.

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 prior data suggests that the PICTURE-THIS protocol is safe for critical illness survivors and their families?

Research has shown that the PICTURE-THIS program aids recovery after intensive care discharge. It emphasizes care and rehabilitation to enhance recovery.

Studies indicate that patients generally receive programs like PICTURE-THIS well. Similar past rehabilitation programs have proven safe and effective, often enhancing physical abilities without serious side effects.

Although this specific program is new, it employs proven methods. Patients report feeling supported, and any side effects are typically mild and manageable.

Overall, PICTURE-THIS seems to be a safe choice for those seeking to enhance recovery after a serious illness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PICTURE-THIS intervention for post-intensive care recovery because it offers a comprehensive approach that combines transitional care management, activity-based rehabilitation, and social support, which are not typically bundled together in current standard care. Unlike the usual care that often focuses on medical management alone, this intervention addresses physical rehabilitation and psychosocial support, aiming to improve recovery outcomes holistically. By providing ongoing support and structured rehabilitation, PICTURE-THIS has the potential to significantly enhance patients' quality of life and recovery speed after intensive care.

What evidence suggests that the PICTURE-THIS protocol is effective for post intensive care recovery?

Research has shown that transitional care and rehabilitation significantly aid recovery after an Intensive Care Unit (ICU) stay. Studies have found that addressing Post Intensive Care Syndrome (PICS) can improve long-term health and reduce healthcare costs. In this trial, researchers will assign participants to different groups to evaluate the effectiveness of the PICTURE-THIS program. The PICTURE-THIS group will engage in physical activities and receive social support, aiming to enhance the quality of life for those who have been in the ICU. Early results suggest these programs help patients regain strength and function more effectively. Additionally, similar online health programs have successfully treated PICS, making the PICTURE-THIS approach promising for people recovering from serious illness. ^{1 2 3 4 6}

Who Is on the Research Team?

Leslie P Scheunemann, MD MPH

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-post-intensive-care-syndrome-7-2023-bd155

PICTURE-THIS Intervention for Post Intensive Care Recovery This is a single-center pilot study examining the feasibility and acceptability of a transitional rehabilitation intervention, PICTURE-THIS, among critical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11215031/

From the Intensive Care Unit to Recovery: Managing Post ... Effective management of PICS not only improves quality of life and reduces healthcare expenses but also enhances long-term functional condition ...

3. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05089-6

Exploring the effectiveness of eHealth interventions in treating ... Exploring the effectiveness of eHealth interventions in treating Post Intensive Care Syndrome (PICS) outcomes: a systematic review. Daniel ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06501365

Post-Intensive Care Transitional Care, Rehabilitation, and ... The goal of this randomized control trial is to test an intervention designed to improve patient and family outcomes after critical illness compared to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949788423000369

Post-ICU Clinic Post-ICU clinics are one way to help patients with PICS and to assist patients in their recovery progress.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12191853/

Supporting Post-ICU Recovery: A Narrative Review for ... This review examines the role of GPs in managing post-ICU patients, outlining common complications, screening tools, rehabilitation strategies, and potential ...