Pilot Testing PICTURE-THIS

December 11, 2025 updated by: Leslie Scheunemann, University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICTURE-THIS services
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
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.
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.
Active Comparator: Enhanced Usual Care
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)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment
Time Frame: Up to 6 months

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
Time Frame: Up to 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROPr
Time Frame: Up to 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Leslie P Scheunemann, MD MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Actual)

October 16, 2025

Study Completion (Actual)

October 16, 2025

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY23010154
  • K08HS027210 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be available from the PI upon request with a Data Use Agreement

IPD Sharing Time Frame

Per any negotiated Data Use Agreement

IPD Sharing Access Criteria

Negotiated Data Use Agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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