Pilot Testing PICTURE-THIS

NCT06086301 | Completed

• 2 other identifiers: STUDY23010154K08HS027210
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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. 1.User testing the PICTURE-THIS protocol to work out basic challenges to feasibility and acceptability.
2. 2.Assessing the feasibility and acceptability of the user-tested PICTURE-THIS protocol.
3. 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.

Conditions

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

Keywords

Pilot Study; Critical Illness Survivors; Family Caregivers; Transitional care; Rehabilitation; Family Support

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• PROPr

  Up to 6 months

Study Arms (2)

PICTURE-THIS services

EXPERIMENTAL

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.

Other: PICTURE-THIS; Behavioral: Run-In Phase

Enhanced Usual Care

ACTIVE COMPARATOR

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)

Other: Enhanced Usual Care; Behavioral: Run-In Phase

Interventions

PICTURE-THIS OTHER

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.

PICTURE-THIS services

Enhanced Usual Care OTHER

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.

Enhanced Usual Care

Run-In Phase BEHAVIORAL

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.

Enhanced Usual Care; PICTURE-THIS services

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• No identified caregiver. Unable to participate in English. Resides outside of Pennsylvania.
• ≥21 years old. English-speaking. Providing support to the patient since the ICU stay
• None
• Providing health services to a PICTURE-THIS dyad Willing to complete a survey
• None

Sponsors & Collaborators

• University of Pittsburgh: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (22)

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• Scheunemann LP, Motter E, Kim SP, et al. Conceptualizing Transitional Care After Critical Illness Using Stakeholder Perspectives: A Qualitative Content Analysis. Under review. Published online 2023.

  BACKGROUND

• Moale AC, Motter EM, Eisenhauer P, Gandhi N, Kim SP, Girard TD, Reynolds CF 3rd, Leland NE, Chang JC, Scheunemann LP. Integrating Perspectives on Family Caregiving After Critical Illness: A Qualitative Content Analysis. Am J Crit Care. 2024 May 1;33(3):180-189. doi: 10.4037/ajcc2024309.

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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.

  BACKGROUND

• 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.

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MeSH Terms

Conditions

postintensive care syndrome

Study Officials

• Leslie P Scheunemann, MD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: August 9, 2023
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Per any negotiated Data Use Agreement
• Access Criteria: Negotiated Data Use Agreement

Locations

US (1)