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Completed

NCT Number: NCT04490278

CoV-PICS: A Virtual Post-ICU Clinic

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.

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Key information

Conditions

Post ICU Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Record Review - Inpatient Treatment

Other

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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