An interventional study of Medical Record Review - Inpatient Treatment and Online Questionnaires in Post ICU Syndrome, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
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.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Medical Record Review - Inpatient Treatment · Other: Online Questionnaires
Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record
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.
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
Time frame: up to 6 months after consent
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
Time frame: up to 6 months after consent
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
Time frame: up to 6 months after consent
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
Time frame: Up to 6 months after consent
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
Time frame: Approximately 60 days after initial visit (scheduling dependent)
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.
Time frame: Up to 6 months after consent
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
Time frame: Approximately 60 days after initial visit (scheduling dependent)
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
Time frame: Up to 6 months after consent
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
Time frame: Approximately 60 days after initial visit (scheduling dependent)
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.
Time frame: up to 6 months after consent
| Milestone | Patients With PICS |
|---|---|
| Started | 20 |
| Completed | 14 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 6 |
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
| score on a scale | Patients With PICS |
|---|---|
| Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM | 4.8 ± 0.31 |
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
| score on a scale | Patients With PICS |
|---|---|
| Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM | 4.6 ± 0.69 |
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
| score on a scale | Patients With PICS |
|---|---|
| Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM | 4.7 ± 0.55 |
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
| score on a scale | Patients With PICS |
|---|---|
| Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1 | 5.4 ± 1.1 |
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
| score on a scale | Patients With PICS |
|---|---|
| Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2 | 5.8 ± 0.6 |
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.
| score on a scale | Patients With PICS |
|---|---|
| Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1 | 11.9 ± 2.1 |
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
| score on a scale | Patients With PICS |
|---|---|
| Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2 | 11.1 ± 2.1 |
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
| Participants | Patients With PICS |
|---|---|
| 0-1 no risk | 3 |
| 2-3 mild risk | 8 |
| 4-8 moderate risk | 0 |
| 9 or more severe risk | 3 |
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
| Participants | Patients With PICS |
|---|---|
| 0-1 no risk | 3 |
| 2-3 mild risk | 8 |
| 4-8 moderate risk | 0 |
| 9 or more severe risk | 3 |
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.
| number of memories | Patients With PICS |
|---|---|
| Number of Factual memories | 106 |
| Number Feelings and memories | 49 |
| Number of delusions | 38 |
| Unexplained feelings of panic | 7 |
| Intrusive Memories | 7 |
Collected over 6 months after consent.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With PICS | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Patients With PICS |
|---|---|
| Mean | 62.5 ± 10.9 |
| Sex: Female, Male(Participants) | Patients With PICS |
|---|---|
| Female | 9 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Patients With PICS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Patients With PICS |
|---|---|
| United States | 14 |
| Body Mass Index (BMI)(kg/m^2) | Patients With PICS |
|---|---|
| Mean | 30.4 ± 10.8 |
| No comorbidities(Participants) | Patients With PICS |
|---|---|
| Count of participants | 3 |
| Hypertension(Participants) | Patients With PICS |
|---|---|
| Count of participants | 7 |
| Diabetes(Participants) | Patients With PICS |
|---|---|
| Count of participants | 5 |
11 further baseline measures are reported on the registry.
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Washington University School of Medicine