Clinical trial NCT03926533: TelePORT Pilot Study
Official title: Telehealth-Enhanced Patient-Oriented Recovery Trajectory After Intensive Care Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Acute Respiratory Distress Syndrome
Septic Shock
Keywords: Post-Intensive Care Syndrome
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: American Association of Critical Care Nurses
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-04-24
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 6 months
measure: participants will complete the 4-item Likert response Feasibility of Intervention Measure (FIM)
timeFrame: 6 months
measure: Appropriateness
timeFrame: 6 months
Secondary outcomes:
measure: cognitive impairment
timeFrame: 6 months
measure: depression
timeFrame: 6 months
measure: physical impairments
timeFrame: 6 months
measure: QOL
timeFrame: 6 months
measure: anxiety
timeFrame: 6 months
measure: PTSD symptoms will be measured using the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Boehm LM, Danesh V, LaNoue M, Trochez RJ, Jones AC, Kimpel CC, Sevin CM. Factors Influencing Engagement with in-Person Intensive Care Unit Recovery Clinic Services. J Intensive Care Med. 2023 Apr;38(4):375-381. doi: 10.1177/08850666221127154. Epub 2022 Sep 21.
citation: Boehm LM, Danesh V, Eaton TL, McPeake J, Pena MA, Bonnet KR, Stollings JL, Jones AC, Schlundt DG, Sevin CM. Multidisciplinary ICU Recovery Clinic Visits: A Qualitative Analysis of Patient-Provider Dialogues. Chest. 2023 Apr;163(4):843-854. doi: 10.1016/j.chest.2022.10.001. Epub 2022 Oct 13.
citation: Kovaleva MA, Jones AC, Kimpel CC, Lauderdale J, Sevin CM, Stollings JL, Jackson JC, Boehm LM. Patient and caregiver experiences with a telemedicine intensive care unit recovery clinic. Heart Lung. 2023 Mar-Apr;58:47-53. doi: 10.1016/j.hrtlng.2022.11.002. Epub 2022 Nov 15.
citation: Kovaleva MA, Jones AC, Kimpel CC, Lauderdale JL, Sevin CM, Boehm LM. Patients' and Caregivers' Perceptions of Intensive Care Unit Hospitalization and Recovery. Am J Crit Care. 2022 Jul 1;31(4):319-323. doi: 10.4037/ajcc2022945.