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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04490278
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

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.




Primary Outcome Measures :
  1. Acceptance with virtual 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 virtual 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 virtual 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. PICS Symptoms - Daily living [ 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. PICS Systems - Cognitive [ Time Frame: Up to 6 months after consent ]
    Montreal Cognitive Assessment (MoCA) Screening tool for mild cognitive dysfunction. Sum all subscores listed on the right-hand side, for a possible maximum of 15 points. A final total score of 11 and above is considered normal.

  3. PICS Systems - Nutrition [ 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 (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage recommendations.

  4. PICS Systems - PROMIS [ Time Frame: Up to 6 months after consent ]
    Patient-Reported Outcomes Measurement Information System (PROMIS 29) PROMIS Profile instruments are a collection of short forms containing a fixed number of items from seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). The PROMIS-29 assesses each of the 7 domains with 4 questions. Range 1=Never, 2=rarely, 3=sometimes, 4=often, 5=always

  5. PICS Symptoms - Memory [ Time Frame: up to 6 months after consent ]
    ICU Memory Tool 4 item questionnaire of patient's memory of ICU stay. Response scale: factual memories (range 0-11), memories of feelings (range 0-6), delusional memories + 1 for mention of nurse or doctor trying to kill the patient in description (range 0-6)



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Beth Taylor, DCN 314-215-7384 beth.taylor@bjc.org

Locations
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United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Beth Taylor, DCN, RDN-AP, CNSC    314-215-7384    beth.taylor@bjc.org   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Chris Palmer, MD Washington University School of Medicine
Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04490278    
Other Study ID Numbers: 202007053
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

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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