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Post-intensive Care SyndromeNCT06086301

Pilot Testing PICTURE-THIS

A study testing PICTURE-THIS and Run-In Phase in people with Post-intensive Care Syndrome and Transitional Care, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
PICTURE-THIS and Run-In Phase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
9 Aug 2023to 16 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.
  • ≥21 years old. English-speaking. Providing support to the patient since the ICU stay
  • Providing health services to a PICTURE-THIS dyad Willing to complete a survey

Who cannot join

  • No identified caregiver. Unable to participate in English. Resides outside of Pennsylvania.
  • None
  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: 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.
Read the 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.

Being tested
PICTURE-THIS, Enhanced Usual Care, Run-In Phase
Keywords
Pilot Study, Critical Illness Survivors, Family Caregivers, Transitional care, Rehabilitation, Family Support
Medical subject headings
postintensive care syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PICTURE-THISOther

    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 CareOther

    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.

  • Run-In PhaseBehavioural

    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.

Study groups in NCT06086301
Study groupRoleWhat they receive
PICTURE-THIS servicesExperimentalThis 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.
Receives: Other: PICTURE-THIS; Behavioral: Run-In Phase
Enhanced Usual CareActive comparatorEnhanced 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)
Receives: Other: Enhanced Usual Care; Behavioral: Run-In Phase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrollment

    Achieving an enrollment rate of 80% of eligible participants.

    Enrollment Rate (%) = (Number of Enrolled Participants / Number of Eligible Participants) x 100

    Measured: Up to 6 months

  2. 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

    Measured: Up to 6 months

Secondary outcomes (1)
  1. 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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start9 Aug 2023
  3. Primary completion16 Oct 2025
  4. Study completion16 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086301
Sponsor's protocol ID
STUDY23010154
Other IDs
K08HS027210
Status last verified
Dec 2025
First submitted
10 Oct 2023
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be available from the PI upon request with a Data Use Agreement

Publications

  • LaMantia MA, Scheunemann LP, Viera AJ, Busby-Whitehead J, Hanson LC. Interventions to improve transitional care between nursing homes and hospitals: a systematic review. J Am Geriatr Soc. 2010 Apr;58(4):777-82. doi: 10.1111/j.1532-5415.2010.02776.x.

    PubMed 20398162
  • Polgar P, Taylor L. Alterations in prostaglandin synthesis during senescence of human lung fibroblasts. Mech Ageing Dev. 1980 Apr;12(4):305-10. doi: 10.1016/0047-6374(80)90063-9.

    PubMed 6993800
  • Bailey CL. The treatment of malaria. N Engl J Med. 1997 Mar 6;336(10):733; author reply 733-4. doi: 10.1056/NEJM199703063361017. No abstract available.

    PubMed 9045053
  • 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.

  • 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.

    PubMed 38688852
  • 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.

  • 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.

    PubMed 31751152
  • Scheunemann LP, Girard TD, Leland NE. Epidemiological Conceptual Models and Health Justice for Critically Ill Older Adults. Crit Care Med. 2021 Feb 1;49(2):375-379. doi: 10.1097/CCM.0000000000004793. No abstract available.

    PubMed 33438978
  • Naylor MD, Sochalski JA. Scaling up: bringing the transitional care model into the mainstream. Issue Brief (Commonw Fund). 2010 Nov;103:1-12.

    PubMed 21053533
  • Hirschman KB, Shaid E, McCauley K, Pauly MV, Naylor MD. Continuity of Care: The Transitional Care Model. Online J Issues Nurs. 2015 Sep 30;20(3):1.

    PubMed 26882510
  • Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.

    PubMed 15086645
  • Naylor MD, Hirschman KB, Toles MP, Jarrin OF, Shaid E, Pauly MV. Adaptations of the evidence-based Transitional Care Model in the U.S. Soc Sci Med. 2018 Sep;213:28-36. doi: 10.1016/j.socscimed.2018.07.023. Epub 2018 Jul 17.

    PubMed 30055423
  • Skidmore ER, Swafford M, Juengst SB, Terhorst L. Self-Awareness and Recovery of Independence With Strategy Training. Am J Occup Ther. 2018 Jan/Feb;72(1):7201345010p1-7201345010p5. doi: 10.5014/ajot.2018.023556.

    PubMed 29280726
  • Berker F, Sandalci C, Ucer O. [Rare complication observed during the course of diabetes mellitus]. Turk Tip Cemiy Mecm. 1969;35(8):483-8. No abstract available. Turkish.

    PubMed 5368028
  • Dynovskii GD. [Late aftereffects of cranio-cerebral injuries]. Vrach Delo. 1974 Jun;(6):108-10. No abstract available. Russian.

    PubMed 4466065

Questions about this trial

What is this clinical trial studying?

A study testing PICTURE-THIS and Run-In Phase in people with Post-intensive Care Syndrome and Transitional Care, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrollment (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06086301, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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