Pilot Testing PICTURE-THIS

NCT06086301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

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

Interventions

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.

OTHER

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.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED
  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Leslie P Scheunemann, MD MPH · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2025-10-16
Completion
2025-10-16

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06086301 on ClinicalTrials.gov