TelePORT Pilot Study

Vanderbilt University

Status: Completed

Conditions: Critical Illness; Acute Respiratory Distress Syndrome; Septic Shock

Treatments: Other: Telehealth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03926533

190790

Details and patient eligibility

About

Although more than 50% of survivors of critical illness experience one or more post-intensive care syndrome (PICS) problems, there are still no validated interventions for the management of PICS. The long-term goal of this study is to develop and refine in-person and telehealth strategies for the delivery of Intensive Care Unit (ICU) recovery care for the treatment of PICS.

Full description

The overall objectives in this application are to (a) examine the feasibility of providing telehealth ICU recovery care and (b) determine if ICU recovery care is effective. The central hypothesis is that ICU recovery care improves cognitive, mental health, and physical function of ICU survivors by application of a patient-centered survivorship care plan with targeted interventions to address patient-specific cognitive, mental health, and physical dysfunctions. The rationale for this project is that a determination of the feasibility of telehealth and effectiveness of ICU recovery care in general is likely to offer a strong scientific framework informing the development of new implementation strategies. We will test the central hypotheses by pursuing two specific aims: 1) Test that telehealth ICU recovery care is feasible, and 2) Test the hypothesis that telehealth ICU recovery care compared to standard of care conditions will be more effective for improvement in cognitive, mental health, physical, and global function at 6 months following hospital discharge. To address these aims, we will enroll patients treated for septic shock and acute respiratory distress syndrome in the medical and surgical ICUs at Vanderbilt University Medical Center. Study patients will be randomized 1:1 to either the telehealth ICU recovery care or standard of care groups. We will conduct telehealth ICU recovery care from the Vanderbilt ICU Recovery Center. This ICU survivor clinic relies on the expertise of clinicians from critical care medicine, nursing, pharmacy, neuropsychology, rehabilitation, and case management to assess and manage PICS. Telehealth feasibility measures include appropriateness, acceptability, and implementability. Following telehealth clinic participation at 3 weeks and 3 months after hospital discharge, we will assess participants for cognitive, mental health, physical, and global quality of life outcomes using trained, blinded research personnel at 6 months following hospital discharge. We incorporated PROMIS patient-centered outcome measures into each patient outcome category. This research is significant because it is expected to provide scientific justification for the continued development and implementation of ICU recovery care programs. Ultimately, such knowledge has the potential to improve the quality of life for millions of ICU survivors and their family members.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

1. no access to computer, electronic device (e.g., tablet, smartphone), and/or internet connection for virtual clinic visit,
2. primary care received outside of VUMC network,
3. hospice care at discharge,
4. substance abuse or psychiatric disorder that prevents independent living,
5. blind, deaf, unable to speak English, or
6. severe dementia prior to index hospitalization

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

Telehealth ICU Recovery Program

Experimental group

Description:

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.

Treatment:

Other: Telehealth

Standard Recovery Conditions

No Intervention group

Description:

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.