CoV-PICS: A Virtual Post-ICU Clinic
- Conditions
- Post ICU Syndrome
- Interventions
- Other: Medical Record Review - Inpatient TreatmentOther: Online Questionnaires
- Registration Number
- NCT04490278
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with PICS Medical Record Review - Inpatient Treatment - Patients with PICS Online Questionnaires -
- Primary Outcome Measures
Name Time Method Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM 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
Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM 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
Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM 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
Name Time Method Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1 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.
Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2 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
Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1 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
Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2 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
Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit 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 interventionPost Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit 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 interventionPost Intensive Care Syndrome (PICS) Symptoms - Memory 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.
Trial Locations
- Locations (1)
Washington University School of Medicine/Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States