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Telehealth for Septic Shock (TelePORT Trial)

N/A

Waitlist Available

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

index ICU stay with a diagnosis of sepsis or acute respiratory distress syndrome projected to be discharged alive as these patients are at the highest risk for developing PICS

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

TelePORT Trial Summary

This trial is testing different ways of providing care to people who have survived critical illness and are experiencing post-intensive care syndrome (PICS) problems.

Eligible Conditions

Septic Shock
Critical Illness
Acute Respiratory Distress Syndrome

TelePORT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TelePORT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Appropriateness

participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM)

Secondary outcome measures

PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5)

QOL

anxiety

+3 more

TelePORT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth ICU Recovery ProgramExperimental Treatment1 Intervention

Components of the ICU RC telehealth visit will be structured parallel to what is done during a typical in-person clinic visit. The telehealth intervention consists of 5 chronological components conducted during two 1.5 hour telehealth clinic visits (the same time required for an in-person visit). Upon completion of the pre-intervention baseline assessment, the study coordinator will contact patients randomized to the intervention arm to schedule the first telehealth visit. Study visits will occur at 3 weeks and 3 months following hospital discharge.

Group II: Standard Recovery ConditionsActive Control1 Intervention

participants assigned to the standard of care control group will be contacted by the study coordinator to ensure the patient has a primary care and/or specialist appointment scheduled. At this time, patients will also receive an electronic PICS guide for ICU survivors created by the Society of Critical Care Medicine. Patients will be directed to use the information provided in the PICS guide for ICU survivors to connect with resources.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Association of Critical Care NursesOTHER

3 Previous Clinical Trials

90 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,405 Total Patients Enrolled

2 Trials studying Septic Shock

2,214 Patients Enrolled for Septic Shock

American Association of Critical-Care NursesUNKNOWN

2 Previous Clinical Trials

90 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate participant count in this experiment?

"Affirmative. On clinicaltrials.gov, it is evident that this trial commenced on November 1st 2019 and has recently been updated in December 5th 2022. This research endeavour necessitates 90 participants across a single medical centre."

Answered by AI

Is this research actively recruiting participants?

"The trial is actively seeking candidates; the initial listing was posted on November 1st 2019 and most recently revised on December 5th 2022, as per clinicaltrials.gov."

Answered by AI

What are the core goals of this clinical trial?

"The objective of this 6-month clinical trial is to have participants finish the Feasibility of Intervention Measure (FIM) that consists of 4 Likert responses. Secondary analyses account for cognitive impairment, measured through The MOCA-Blind with a score range from 0 to 22; anxiety as assessed by PROMIS Anxiety v1.0 using T-scores ranging between 40 and 60; physical impairments tracked via PROMIS Physical Function v2.0 also utilizing T-score calibration; and respiratory function scrutinized through St. George Respiratory Questionnaire's 80 point scale measuring health impairment levels."

Answered by AI

Recent research and studies

International Journal of Psychiatry in Clinical PracticeJournal

Increased Co-morbidity of Depression and Post-traumatic Stress Disorder Symptoms and Common Risk Factors in Intensive Care Unit Survivors: A Two-year Follow-up Study

Paparrigopoulos, Thomas, Antigone Melissaki, Elias Tzavellas, Dimitris Karaiskos, Ioannis Ilias, and Nikolaos Kokras. 2014. “Increased Co-morbidity of Depression and Post-traumatic Stress Disorder Symptoms and Common Risk Factors in Intensive Care Unit Survivors: A Two-year Follow-up Study”. International Journal of Psychiatry in Clinical Practice. Informa UK Limited. doi:10.3109/13651501.2013.855793.

AJN, American Journal of NursingJournal

A. Khan, Babar, Sue Lasiter, and Malaz A. Boustani. 2015. “Ce”. AJN, American Journal of Nursing. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.naj.0000461807.42226.3e.

The Lancet Respiratory MedicineJournal

Depression, Post-traumatic Stress Disorder, and Functional Disability in Survivors of Critical Illness in the BRAIN-ICU Study: A Longitudinal Cohort Study

Jackson, James C, Pratik P Pandharipande, Timothy D Girard, Nathan E Brummel, Jennifer L Thompson, Christopher G Hughes, Brenda T Pun, et al.. 2014. “Depression, Post-traumatic Stress Disorder, and Functional Disability in Survivors of Critical Illness in the BRAIN-ICU Study: A Longitudinal Cohort Study”. The Lancet Respiratory Medicine. Elsevier BV. doi:10.1016/s2213-2600(14)70051-7.

Critical Care MedicineJournal

Improving Long-term Outcomes After Discharge from Intensive Care Unit