CoV-PICS: A Virtual Post-ICU Clinic

NCT04490278 | Completed Results

• 1 other identifier: 202007053
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post ICU Syndrome

Outcome Measures

Primary Outcomes (3)

• Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM

  Acceptability of Intervention Measure (AIM) Implementation of outcome measure. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree

  up to 6 months after consent

• Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM

  Intervention Appropriateness Measure (IAM) Implementation of outcome measure. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree

  up to 6 months after consent

• Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM

  Feasibility of Intervention Measure (FIM) Implementation of outcome measure. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree

  up to 6 months after consent

Secondary Outcomes (7)

• Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1

  Up to 6 months after consent

• Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2

  Approximately 60 days after initial visit (scheduling dependent)

• Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1

  Up to 6 months after consent

• Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2

  Approximately 60 days after initial visit (scheduling dependent)

• Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit

  Up to 6 months after consent

Study Arms (1)

Patients with PICS

EXPERIMENTAL

Other: Medical Record Review - Inpatient Treatment; Other: Online Questionnaires

Interventions

Medical Record Review - Inpatient Treatment OTHER

Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record

Patients with PICS

Online Questionnaires OTHER

Patients will complete online questionnaires related to their physical, cognitive and mental health function and inquire about current treatments. The multiprofessional CoV-PICS clinic practitioners will evaluate their responses and, combined with information obtained during their virtual visits, formulate a suggested treatment plan and needed referrals.

Patients with PICS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32221172 BACKGROUND

• 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.

  PMID: 28721340 BACKGROUND

Results Point of Contact

• Title: Chris Palmer
• Organization: Washington University

cmpalmer@wustl.edu

314-215-7384

Study Officials

• Chris Palmer, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof of Anesthesiology

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: September 29, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 16, 2023
• Results First Posted: March 16, 2023

Record last verified: 2022-06

Locations

US (1)