Telemedicine for Post Intensive Care Syndrome

(TelePORT Trial)

Recruiting at 1 trial location

Overseen By Leanne M Boehm, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: Hospice care, No device access, Substance abuse, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

202 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telemedicine, specifically the Telehealth-enhanced Patient-oriented Recovery Trajectory (TelePORT Study), can improve recovery from cognitive issues after an ICU stay. It targets patients who received breathing support or treatment for septic shock, a severe infection causing organ failure. Participants will either have scheduled telemedicine visits after hospital discharge or follow usual care plans. This trial suits adults treated in an ICU who have access to a device like a smartphone or tablet for video calls. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance recovery for future ICU patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this telemedicine intervention is safe for post-intensive care syndrome patients?

Research has shown that telehealth programs, like the one in this study, can improve patient recovery after intensive care. These programs use technology to help patients adhere to their care plans and achieve better long-term health.

A small initial study found this telehealth method practical and helpful. It's important to note that because this study is not in a typical clinical trial phase, there might be less information on safety compared to later-stage trials. However, telehealth is generally considered safe, as it primarily involves remote consultations and personalized care plans, which do not carry the same risks as new drugs or medical procedures.

Overall, telehealth has proven to be a safe way to support recovery for patients after hospital discharge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of telemedicine for Post Intensive Care Syndrome (PICS) because it offers a more personalized and accessible approach to recovery compared to traditional methods. Unlike standard follow-up care, which typically involves in-person visits and generalized resources, this telehealth-enhanced protocol provides scheduled virtual check-ins at three weeks and three months after hospital discharge. This approach aims to tailor recovery to the individual’s needs and offers the convenience of accessing care from home, potentially improving patient outcomes and satisfaction. By leveraging technology, this method also hopes to bridge gaps in care accessibility, especially for those who might face challenges in attending in-person appointments.

What evidence suggests that telemedicine is effective for post-intensive care syndrome?

Research has shown that telehealth programs can help patients recover better after leaving intensive care. These programs simplify following doctor's advice and adhering to recovery plans. Some studies suggest that online health services can improve recovery from post-intensive care syndrome (PICS), which affects cognitive skills needed for daily activities. In this trial, participants in the Telemedicine ICU Recovery Clinic arm will have scheduled telemedicine visits to support their recovery. The TelePORT pilot study found that using telemedicine for recovery after intensive care is feasible and shows promise in helping patients regain cognitive abilities. Overall, telehealth could be a useful tool for improving life after intensive care. ^{1 2 3 5 6}

Who Is on the Research Team?

Leanne M Boehm, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for adults over 45 who were in a medical or surgical ICU, treated for acute respiratory failure with mechanical ventilation and/or septic shock with vasopressors. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am 45 or older and have been admitted to an ICU.

I have been treated with a breathing machine or medications for blood pressure due to severe infection or breathing failure.

Exclusion Criteria

No access to a computer or electronic device (e.g., tablet, smart phone) with cellular or WiFi connection for a telemedicine clinic visit

Hospice care at discharge or not expected to survive 6 months

Substance abuse or psychiatric disorder that prevents independent living

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Telemedicine ICU Recovery Clinic visits scheduled 3 weeks and 3 months after hospital discharge

3 months

Minimum of 2 visits (telemedicine)

Follow-up

Participants are monitored for cognitive, physical, and mental health function, and social integration at 6 months post-discharge

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth-enhanced Patient-oriented Recovery Trajectory

Trial Overview

The TelePORT Study is testing the use of telemedicine visits to help patients recover cognitive skills after intensive care. It aims to see if this can improve their ability to live independently and manage daily tasks.

How Is the Trial Designed?

Group I: Telemedicine ICU Recovery Clinic Experimental Treatment 1 Intervention

scheduled telemedicine study visits 3 weeks and 3 months after hospital discharge or return-to-home if discharged to another facility

Group II: Standard Recovery Conditions (i.e., Control) Active Control 1 Intervention

Control group participants will proceed with follow-up as determined by the discharging hospital team and directed to use the provided PICS guide to connect with commonly used resources.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The study successfully assessed cognitive and sensorimotor function in ICU patients at 3 and 12 months post-discharge, revealing that a significant portion of participants exhibited impairments in visuospatial skills (54% at 3 months and 32% at 12 months).

Despite the feasibility of the multimodal data collection strategy, retention of participants was a challenge, with only 40% returning at 3 months and 31% at 12 months, indicating a need for improved strategies to encourage follow-up participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. Wood, MD., Maslove, DM., Muscedere, J., et al.[2019]

A telemedical program significantly improved adherence to seven key quality indicators in intensive care units, enhancing aspects like sedation management and infection control, based on a study of 1463 patients across 12 ICU clusters in Germany.

The intervention led to substantial improvements in patient care processes, with adjusted odds ratios indicating strong effectiveness in areas such as ventilation and patient communication, although no difference was found in adherence to daily clinical visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an intensive care telehealth programme to improve process quality (ERIC): a multicentre stepped wedge cluster randomised controlled trial. Spies, CD., Paul, N., Adrion, C., et al.[2023]

Adverse events leading to intensive care unit (ICU) admissions can range from 1.1% to 37.2% of cases, with a significant portion (17% to 76.5%) being preventable, highlighting the need for improved patient monitoring and response systems.

The consequences of these adverse events include increased ICU stay lengths (averaging 1.5 to 10.4 days) and mortality rates that can reach up to 58%, indicating a serious impact on patient outcomes and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and preventability of adverse events requiring intensive care admission: a systematic review. Vlayen, A., Verelst, S., Bekkering, GE., et al.[2022]

In a study of 88 critically ill patients, 52.3% experienced adverse events, which were linked to increased care needs, greater severity of illness, and longer hospital stays.

The average Nursing Activities Score indicated that patients required about 12 hours and 24 minutes of care, highlighting a significant nursing staff shortage of 20% to 30%, which may contribute to the high prevalence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in critically ill patients: a cross-sectional study. Assis, SF., Vieira, DFVB., Sousa, FREG., et al.[2023]

Patients and caregivers found telemedicine ICU Recovery Clinics (ICU-RCs) to be acceptable and convenient, facilitating thorough discussions and providing reassurance and validation, which are crucial for post-intensive care recovery.

The study identified key areas for improvement, such as scheduling follow-up visits and personalizing content, highlighting the potential for telemedicine ICU-RCs to effectively support more ICU survivors in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and caregiver experiences with a telemedicine intensive care unit recovery clinic. Kovaleva, MA., Jones, AC., Kimpel, CC., et al.[2023]

Telemedical programs in critical care can improve resource allocation and adherence to best practices, potentially reducing mortality and length of hospital stays, especially in the face of increasing patient complexity and a shortage of intensivists.

The Enhanced Recovery after Intensive Care (ERIC) trial, involving 1431 patients, aims to assess the effectiveness of telemedicine in improving adherence to quality indicators for acute critical care and will also evaluate long-term patient outcomes three and six months post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Avoiding Long-term Impairment in Critical Care Using Telemedicine: The ERIC Example]. Weiss, B., Paul, N., Kraufmann, B., et al.[2022]

Patients and caregivers reported that ICU hospitalization was often a scary and traumatic experience, highlighting the need for better communication and realistic prognostication about recovery.

The study emphasized the importance of mental health support and physical therapy in post-ICU recovery, suggesting that ICU recovery clinics should prioritize these components to enhance patient and family-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' and Caregivers' Perceptions of Intensive Care Unit Hospitalization and Recovery. Kovaleva, MA., Jones, AC., Kimpel, CC., et al.[2023]

In a study of 1017 critically ill patients across 79 intensive care units, 58% experienced at least one incident, with a total of 1424 incidents reported, including 943 no-harm events (NHEs) and 481 adverse events (AEs).

The majority of incidents (74%) were related to medication, equipment, and nursing care, with 79% of incidents deemed avoidable, highlighting significant opportunities for improving patient safety in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in Spanish intensive care units: the SYREC study. Merino, P., Álvarez, J., Cruz Martín, M., et al.[2016]

A study involving 48 children under 4 years old who required over 12 hours of mechanical ventilation showed that virtual follow-up using web-based Ages and Stages Questionnaires (ASQ-3) is feasible for screening developmental delays after PICU discharge.

Of the children who completed the ASQ-3, 50% were identified as at-risk for developmental delays and referred for early intervention, highlighting the effectiveness of this method, especially for families needing additional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Developmental Screening After Invasive Mechanical Ventilation in Children: A Prospective Cohort Pilot Study. Bartel, NJ., Boyle, DW., Hines, AC., et al.[2023]

Citations

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This online presentation will describe the aims, methods, feasibility, and quantitative and qualitative findings from the TelePORT pilot study.

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The use of eHealth interventions to rehabilitate patients in the early post-discharge phase could promote better PICS recovery. Evidence from ...

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Post-ICU Clinic

We report herein how we have structured our ICU recovery clinic and highlight important elements to consider when evaluating patients in a post-ICU clinic, ...

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Organizational Determinants of ICU Telemedicine ...

Ultimately, these results will provide clinicians, hospital administrators with immediate, actionable data about how to use ICU telemedicine most effectively ...