Pilot Testing PICTURE-THIS

Critical Care Clinical Trial

Official title:

Pilot Testing Post-Intensive Care Transitions Using Rehabilitation and Engagement To Heal ICU Survivors and Families (PICTURE-THIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086301
• Other study ID #: STUDY23010154
• Secondary ID: K08HS027210
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: Leslie P Scheunemann, MD MPH
• Phone: 9197400412
• Email: scheunemannlp[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria for Patient Participants:

=50 years old. Admitted from home. Spend =48 hours in an ICU. Have an attending prognosis = 12 months.

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

Related Conditions & MeSH terms

• Critical Care
• Health Services
• Post-intensive Care Syndrome
• Transitional Care

Intervention

Other:
• PICTURE-THIS
Discharge plans include scheduling post-discharge appointments, community support referrals, transportation arrangements, and addressing identified gaps. Transition care includes 8 check-ins over 3 months post-discharge, focusing on assessing, troubleshooting, and celebrating transition successes, using phone or video. Telehealth-assisted 'warm hand-offs' will connect interventionists with home health and primary care teams during initial visits. '1st touch daytime troubleshooting' offers extra support between check-ins. Problem-solving rehabilitation will be continued from hospital to home, with 7-10 sessions over 3 months, including a home safety survey. A Post-ICU Caregiver Toolkit provides workbooks, training videos, and resources. Lastly, referrals for patient and caregiver social/mental health support are provided.
• Enhanced Usual Care
Enhanced Usual Care (EUC) control group will receive: (1) Patient and Family Re-sources published by the SCCM for PICS prior to hospital discharge; (2) ongoing assessments on the same schedule as the PICTURE-THIS intervention; (3) referral for urgent or emergent issues identified during assessments. The investigators will not provide the URL for the Post-ICU Caregiving Toolkit but the investigators will not restrict its access either. This control design balances 3 goals: 1) masking participants to group allocation; 2) responding ethically to harm/distress; 3) maintaining group separation to optimize efficacy testing of PICTURE-THIS.

Behavioral:
• Run-In Phase
All participants receive a Run-In Phase during the acute critical illness hospitalization. It consists of 3 inpatient study visits: (1) health and social screening; (2) planning for rehabilitation; (3) discharge education and training.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Lewis A, Scheunemann LP, Roberts ET. Who, what, and where matter: Social determinants of health and functional outcomes in critical illness survivors. AcademyHealth Research Conference. Published online June 2022.

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Scheunemann LP, Leland NE, Perera S, Skidmore ER, Reynolds CF, Pandharipande PP, Jackson JC, Ely EW, Girard TD. Sex Disparities and Functional Outcomes after a Critical Illness. Am J Respir Crit Care Med. 2020 Apr 1;201(7):869-872. doi: 10.1164/rccm.201902-0328LE. No abstract available. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Achieving an enrollment rate of 80% of eligible participants.; Enrollment Rate (%) = (Number of Enrolled Participants / Number of Eligible Participants) x 100	Up to 6 months
Primary	Retention	Maintaining an active engagement and complete participation rate of 80% throughout the study.; Retention Rate (%) = (Number of Retained Participants / Number of Enrolled Participants) x 100	Up to 6 months
Secondary	PROPr	PROPr gives health utility score integrating 7 domains (physical function, depression, fatigue, cognitive function, role satisfaction, sleep, and pain) using the PROMIS-29; Scoring: Total scores range from 6 to 24, derived from 6 items scored on a 1-to-4 scale. Lower scores denote lower functional levels.	Up to 6 months