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CoV-PICS: A Virtual Post-ICU Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04490278
Recruitment Status : Completed
First Posted : July 29, 2020
Results First Posted : March 16, 2023
Last Update Posted : March 16, 2023
Sponsor:
Information provided by (Responsible Party):
Chris M Palmer, Washington University School of Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post ICU Syndrome Other: Medical Record Review - Inpatient Treatment Other: Online Questionnaires Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: Modern, Convenient and Practical Recovery Care
Actual Study Start Date : September 29, 2020
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with PICS Other: Medical Record Review - Inpatient Treatment
Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record

Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM [ Time Frame: up to 6 months after consent ]
    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

  2. Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM [ Time Frame: up to 6 months after consent ]
    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

  3. Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM [ Time Frame: up to 6 months after consent ]
    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


Secondary Outcome Measures :
  1. Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1 [ Time Frame: Up to 6 months after consent ]
    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

  2. Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2 [ Time Frame: Approximately 60 days after initial visit (scheduling dependent) ]
    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

  3. Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1 [ Time Frame: Up to 6 months after consent ]
    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.

  4. Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2 [ Time Frame: Approximately 60 days after initial visit (scheduling dependent) ]
    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

  5. Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit [ Time Frame: Up to 6 months after consent ]

    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


  6. Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit [ Time Frame: Approximately 60 days after initial visit (scheduling dependent) ]

    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


  7. Post Intensive Care Syndrome (PICS) Symptoms - Memory [ Time Frame: up to 6 months after consent ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490278


Locations
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United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Chris Palmer, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Chris M Palmer, Washington University School of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] August 27, 2020
Informed Consent Form  [PDF] August 11, 2020

More Information
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Publications:

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Responsible Party: Chris M Palmer, Assoc Prof of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04490278    
Other Study ID Numbers: 202007053
First Posted: July 29, 2020    Key Record Dates
Results First Posted: March 16, 2023
Last Update Posted: March 16, 2023
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes