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

Trial Summary

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 data supports the effectiveness of the treatment Telehealth-enhanced Patient-oriented Recovery Trajectory (TelePORT) for Post Intensive Care Syndrome?

Research suggests that telehealth programs in intensive care can improve patient recovery and long-term outcomes by enhancing the quality of care and adherence to best practices. These programs have shown reductions in mortality and length of stay, indicating potential benefits for post-intensive care recovery. ^{1 2 3 4 5}

Is telemedicine for post-intensive care syndrome safe for humans?

Telehealth-based recovery clinics for intensive care unit patients have been used to improve access to care, and while specific safety data for telemedicine in post-intensive care syndrome isn't detailed, telehealth is generally considered safe for human use. ^{1 6 7 8 9}

How is the TelePORT treatment different from other treatments for post-intensive care syndrome?

The TelePORT treatment is unique because it uses telemedicine to enhance patient recovery after intensive care, focusing on increasing adherence to quality care indicators and providing follow-up care through telehealth, which can improve access and long-term outcomes for patients. ^{1 2 3 4 5}

What is the purpose of this trial?

Intact cognitive skills are necessary for independent living, going to work, and managing finances, and any loss of cognitive skills places a burden on society akin to what is seen with Alzheimer's Disease and Related Dementias. The TelePORT Study (Telehealth-Enhanced Patient-Oriented Recovery Trajectories after Intensive Care) is the first post-intensive care syndrome longitudinal long-term cognitive impairment intervention study. The societal effect from long-term cognitive impairment after critical illness is great as many of these patients are employable adults or functional retirees.

Research Team

Leanne M Boehm, PhD

Principal Investigator

Vanderbilt University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patients' and Caregivers' Perceptions of Intensive Care Unit Hospitalization and Recovery. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Patient and caregiver experiences with a telemedicine intensive care unit recovery clinic. [2023]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Robotic technology provides objective and quantifiable metrics of neurocognitive functioning in survivors of critical illness:A feasibility study. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Avoiding Long-term Impairment in Critical Care Using Telemedicine: The ERIC Example]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Incidence and preventability of adverse events requiring intensive care admission: a systematic review. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Adverse events in critically ill patients: a cross-sectional study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events in Spanish intensive care units: the SYREC study. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Virtual Developmental Screening After Invasive Mechanical Ventilation in Children: A Prospective Cohort Pilot Study. [2023]