Clinical trial NCT06086301: Pilot Testing PICTURE-THIS
Official title: Pilot Testing Post-Intensive Care Transitions Using Rehabilitation and Engagement to Heal ICU Survivors and Families (PICTURE-THIS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-intensive Care Syndrome
Transitional Care
Critical Care
Health Services
Keywords: Pilot Study
Critical Illness Survivors
Family Caregivers
Transitional care
Rehabilitation
Family Support
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Purpose: PICTURE-THIS is a transitional rehabilitation intervention for critical illness survivors and their family caregivers. It has 2 phases: (1) A Run-In Phase in the hospital; (2) A post-discharge phase. The purpose of this study is to user- and pilot-test the protocols for PICTURE-THIS.

Aim 1: To test, troubleshoot, and revise study procedures and protocols for PICTURE-THIS with a convenience sample of critical illness survivors and their family caregivers.

The investigators will: 1) ensure that dyads reliably adhere to PICTURE-THIS protocols; 2) troubleshoot assessments at enrollment and 3 and 6 month follow-up; 3) refine data collection and management procedures.

Aim 2: To pilot test PICTURE-THIS for feasibility and acceptability among a convenience sample of critical illness survivors and their family caregivers.

Feasibility will be demonstrated by: 1) \>80% completion of clinical assessments; 2) \>80% retention rate (enrolled patients attending ≥ 2 outpatient transitional care visits and 8 rehabilitation sessions); 2) \>80% completion rate for surveys assessing outcomes.

Acceptability will be demonstrated by: 1) \>80% participants being willing to recommend PICTURE-THIS to others; 2) \>80% global acceptability survey score.

Feasibility and acceptability will be similar in participants living in rural communities compared to those living in urban/suburban ones.

Over half of critical illness survivors develop the Post-Intensive Care Syndrome (PICS), including long-lasting physical, cognitive, and psychological impairments. Without universal transitional care infrastructure, survivors and their families have high rates of unmet needs that result in: (1) adverse events including falls, caregiver stress, rehospitalizations, death and associated with high utilization of healthcare resources; (2) poor long-term outcomes including high symptom burden and reduced quality of life; (3) health disparities related to age, disability status, and income.

Addressing their transitional care needs in the post-ICU context requires a pragmatic, accessible, scalable intervention model. While Critical Illness Recovery Clinics are important hubs of innovation in PICS care, they are not accessible or scalable to meet the public health need which includes \>3 million people in the United States each year. Further, they have not taken advantage of the rich intervention models from the field of transitional care to address care coordination and social needs early after critical illness. Our preliminary research showed that these intervention models can and should be adapted to the post-ICU context. It also suggested that adaptations should incorporate strengths-based rehabilitation interventions aimed at generating a virtuous cycle between mechanisms (e.g., mastery) and outcomes (e.g., participation in meaningful activities) to achieve multidomain wellbeing. Finally, the investigators and others showed that social determinants of health are ubiquitous factors in post-ICU care delivery that must be incorporated into intervention design.

To meet these needs, the investigators adapted evidence-based transitional care, activity-based rehabilitation, and family caregiving interventions into a single intervention called Post-Intensive Care Transitions Using Rehabilitation and Engagement To Heal ICU Survivors and Families (PICTURE-THIS). PICTURE-THIS is delivered by an interdisciplinary team that nimbly supports medical, nursing, rehabilitation, and social care needs in collaboration with existing hospital, home health, and primary care infrastructure. The purpose of this research study is to user and pilot test PICTURE-THIS prior to efficacy testing.

Eligibility criteria: Inclusion Criteria for Patient Participants:

≥50 years old. Admitted from home. Spend ≥48 hours in an ICU. Have an attending prognosis ≥ 12 months. Have some risk of ongoing functional impairment, indicated by a recorded HLM (Highest Level Mobility) \< 8, AMPAC (Activity Measures for Post-Acute Care) \< 24, or ICDSC (Intensive Care Delirium Screening Checklist) \>2.

Exclusion Criteria for Patient Participants:

No identified caregiver. Unable to participate in English. Resides outside of Pennsylvania.

Inclusion Criteria for Family caregiver Participants:

≥21 years old. English-speaking. Providing support to the patient since the ICU stay

Exclusion Criteria for Family Caregiver Participants:

None

Inclusion Criteria for Healthcare Provider Participants:

Providing health services to a PICTURE-THIS dyad Willing to complete a survey

Exclusion Criteria for Healthcare Provider Participants:

None

Primary outcomes:
measure: Enrollment
timeFrame: Up to 6 months
measure: Retention
timeFrame: Up to 6 months
Secondary outcomes:
measure: PROPr
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Leslie P Scheunemann, MD MPH
role: PRINCIPAL_INVESTIGATOR
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