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Search / Trial NCT06501365

Post-Intensive Care Transitional Care, Rehabilitation, and Family-Support

Launched by UNIVERSITY OF PITTSBURGH · Jul 8, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Transitional Care Health Services Critical Care Post Intensive Care Unit Syndrome (Pics) Family Caregiver Support Post Intensive Care Unit Syndrome Family (Pics F)

ClinConnect Summary

This clinical trial is studying a program called Post-Intensive Care Transitions, Rehabilitation, and Family Support (PIC-TRFS) to see if it can help patients and their families after a serious illness that required time in the Intensive Care Unit (ICU). The goal is to find out if this program improves the quality of life for patients and supports their caregivers better than standard care. The PIC-TRFS program includes health management, rehabilitation, social support, and coordination of care. To join the study, patients need to be at least 50 years old, have spent at least 48 hours in the ICU, and be at risk for long-term difficulties after their hospital stay. Caregivers must be adults over 18 who are part of the patient’s support network.

Participants in the study will be randomly assigned to either receive the PIC-TRFS program or standard care, and they will be monitored for their health and well-being over the next year. Those in the intervention group will have regular check-ins through telehealth to provide support and rehabilitation, while those in the control group will receive information about post-ICU challenges. Throughout the study, both groups will complete assessments to measure their physical and mental health, as well as their quality of life. The trial is not currently recruiting participants but is aiming to provide valuable insights into improving recovery and support for patients and their families after critical illness.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • In order to be eligible to participate in this study, a patient must meet all of the following criteria:
  • 1. All genders; Age ≥ 50
  • 2. Admission to the hospital from home/independent living
  • 3. Receive treatment in an ICU for ≥ 48 hours
  • 4. At least some risk of ongoing functional impairment, measured as Activity Measures for Post-Acute Care (AMPAC) \< 24, Highest Level Mobility (HLM) \< 8, or Intensive Care Delirium Screening Checklist (ICDSC) \> 2
  • 5. Provider or e-prognosis that they are reasonably likely to be alive in 12 months (answers no to "Would you be surprised if this person were alive in 12 months?' or eprognosis risk of 1-year mortality \<= 35%
  • 6. Able to participate in English
  • 7. Willingness to adhere to the PIC-TRFS regimen.
  • 8. Provision of signed and dated informed consent form
  • In order to be eligible to participate in this study, a family caregiver must meet all of the following criteria:
  • 1. All genders; Age ≥ 18 years old
  • 2. In the survivor's social network
  • 3. Planning to provide at least some in-home support for the survivor after discharge
  • 4. Able to participate in English
  • 5. Willingness to adhere to the PIC-TRFS regimen
  • 6. Provision of signed and dated informed consent form
  • In order to be eligible for randomization, dyads must meet all of the following criteria:
  • 1. Completion of at least the following elements of the Run-In: medication reconciliation, screening for health and social needs, creation of their event calendar, and hands-on education and training addressing key training needs and event calendar use
  • 2. Discharge to home/independent living
  • Exclusion criteria
  • Survivors will be excluded if any of the following apply:
  • 1. They lack a family caregiver willing to participate;
  • 2. They have a chronic condition for which they are already receiving dedicated transitional care services (e.g., post-cardiac arrest, transplant, TAVR, etc)
  • 3. They have chronic functional dependency without potential to increase participation in meaningful activity
  • 4. They reside outside of Pennsylvania (interventionists are only licensed to practice here)
  • Further, dyads who initially meet inclusion criteria and enter the Run-In will be disenrolled for two reasons:
  • 1. discharge to a location other than home;
  • 2. failure to complete the required elements of the Run-In.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Leslie P Scheunemann, MD, MPH

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported