Clinical trial NCT04490278: CoV-PICS: A Virtual Post-ICU Clinic
Official title: COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: Modern, Convenient and Practical Recovery Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post ICU Syndrome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to evaluate the feasibility of a COVID-19 virtual Post Intensive Care Syndrome (PICS) clinic (CoV-PICS). The findings from this study are the first steps in determining the feasibility and potential impact of a telehealth PICS clinic that is able to address the needs of patients with COVID-19 disease and potentially other patients that are unable to attend a brick and mortar clinic and require virtual care.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* COVID-19 diagnosis with a stay in the ICU.
* A home internet connection or smartphone access, along with the ability to use them
* Missouri resident

Exclusion Criteria:

* Severe cognitive deficits or dementia prior to hospitalization
* Long-term resident of a skilled nursing facility prior to admission
* Non-English speaking (will not have an interpreter available)
* Hospice or Comfort Care at discharge
* No plans to return to some degree of independent living at the time of discharge
* Pregnant at the time of discharge
* Prisoner at the time of discharge
* Blind
* Deaf

Primary outcomes:
measure: Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM
timeFrame: up to 6 months after consent
measure: Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM
timeFrame: up to 6 months after consent
measure: Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM
timeFrame: up to 6 months after consent
Secondary outcomes:
measure: Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1
timeFrame: Up to 6 months after consent
measure: Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2
timeFrame: Approximately 60 days after initial visit (scheduling dependent)
measure: Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1
timeFrame: Up to 6 months after consent
measure: Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2
timeFrame: Approximately 60 days after initial visit (scheduling dependent)
measure: Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit
timeFrame: Up to 6 months after consent
measure: Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit
timeFrame: Approximately 60 days after initial visit (scheduling dependent)
measure: Post Intensive Care Syndrome (PICS) Symptoms - Memory
timeFrame: up to 6 months after consent
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Chris Palmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
citation: Sommer P, Lukovic E, Fagley E, Long DR, Sobol JB, Heller K, Moitra VK, Pauldine R, O'Connor MF, Shahul S, Nunnally ME, Tung A. Initial Clinical Impressions of the Critical Care of COVID-19 Patients in Seattle, New York City, and Chicago. Anesth Analg. 2020 Jul;131(1):55-60. doi: 10.1213/ANE.0000000000004830.
citation: Rawal G, Yadav S, Kumar R. Post-intensive Care Syndrome: an Overview. J Transl Int Med. 2017 Jun 30;5(2):90-92. doi: 10.1515/jtim-2016-0016. eCollection 2017 Jun.