CoV-PICS: A Virtual Post-ICU Clinic

Post ICU Syndrome Clinical Trial

Official title:

COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: Modern, Convenient and Practical Recovery Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490278
• Other study ID #: 202007053
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Post ICU Syndrome
• Syndrome

Intervention

Other:
• Medical Record Review - Inpatient Treatment
Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record
• Online Questionnaires
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine/Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1	Katz Independence in Activities in Daily Living Rates daily activities by independence or dependence in completing the task (range 0-6) 0=low or patient very dependent, 6 = high or patient independent	Up to 6 months after consent
Secondary	Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2	Katz Independence in Activities in Daily Living Rates daily activities by independence or dependence in completing the task (range 0-6) 0=low or patient very dependent, 6 = high or patient independent	Approximately 60 days after initial visit (scheduling dependent)
Secondary	Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1	Montreal Cognitive Assessment (MoCA) Screening tool for mild cognitive dysfunction. Scores range from 0 to 15 with scores of 11 and above considered normal and below 11 considered cognitive impairment.	Up to 6 months after consent
Secondary	Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2	Montreal Cognitive Assessment (MoCA) Screening tool for mild cognitive dysfunction. Scores range from 0 to 15 with scores of 11 and above considered normal and below 11 considered cognitive impairment	Approximately 60 days after initial visit (scheduling dependent)
Secondary	Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit	Scored Patient-Generated Subjective Global Assessment (PG-SGA) The Scored PG-SGA© includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function - also known as the PG-SGA Short Form©), the professional part, the Global Assessment, the total numerical score (0-1 No risk, 2-3 Mild risk, 4-8 Moderate risk, 9 or more High risk), and nutritional triage recommendations based on the score.; For each component of the PG-SGA, points (0-4) are awarded depending on the impact on nutritional status. Typical scores range from 0-35 with a higher score reflecting a greater risk of malnutrition and scores =9 indicating a critical need for nutrition intervention and symptom management; 0-1: no intervention 2-3: patient and family education by dietician or nurse 4-8: requires intervention by dietician >9: critical need for symptom intervention	Up to 6 months after consent
Secondary	Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit	Scored Patient-Generated Subjective Global Assessment (PG-SGA) The Scored PG-SGA© includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function - also known as the PG-SGA Short Form©), the professional part, the Global Assessment, the total numerical score (0-1 No risk, 2-3 Mild risk, 4-8 Moderate risk, 9 or more High risk), and nutritional triage recommendations based on the score.; For each component of the PG-SGA, points (0-4) are awarded depending on the impact on nutritional status. Typical scores range from 0-35 with a higher score reflecting a greater risk of malnutrition and scores =9 indicating a critical need for nutrition intervention and symptom management; 0-1: no intervention 2-3: patient and family education by dietician or nurse 4-8: requires intervention by dietician >9: critical need for symptom intervention	Approximately 60 days after initial visit (scheduling dependent)
Secondary	Post Intensive Care Syndrome (PICS) Symptoms - Memory	ICU Memory Tool (all inclusive tool that measures multiple items as described below); Questionnaire of patient's memory and feelings of ICU stay. Outcomes reported as the total number of memory types per group: factual memories, memories of feelings, delusional memories, unexplained feelings of panic, intrusive memories.	up to 6 months after consent