Post ICU Syndrome
Conditions
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.
Interventions
OTHERMedical Record Review - Inpatient Treatment
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 - 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 - 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
| Measure | Time frame | Description |
|---|---|---|
| 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) 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 intervention |
| 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 - 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. |
| Post 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 intervention |
| 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 - 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With PICS Medical Record Review - Inpatient Treatment: Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record
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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Patients With PICS |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 10.9 |
| Asthma | 2 Participants |
| Body Mass Index (BMI) | 30.4 kg/m^2 STANDARD_DEVIATION 10.8 |
| Cancer | 3 Participants |
| Chronic Kidney Disease | 5 Participants |
| COPD | 1 Participants |
| Diabetes | 5 Participants |
| Discharge location (%) Home | 8 Participants |
| Discharge location (%) Rehabilitation Facility | 6 Participants |
| Hospital length of stay (d) | 21 days |
| Hypertension | 7 Participants |
| ICU length of stay (d) | 11 days |
| No comorbidities | 3 Participants |
| # of patients on ECMO | 0 # of patients on ECMO |
| # of patients on Mechanical Ventilation (%) | 7 Participants |
| Other lung disease | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
| Time on ventilator (d) | 10 days |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM | 4.8 score on a scale | Standard Deviation 0.31 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM | 4.7 score on a scale | Standard Deviation 0.55 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM | 4.6 score on a scale | Standard Deviation 0.69 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1 | 5.4 score on a scale | Standard Deviation 1.1 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2 | 5.8 score on a scale | Standard Deviation 0.6 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Memory | Number of Factual memories | 106 number of memories |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Memory | Number Feelings and memories | 49 number of memories |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Memory | Number of delusions | 38 number of memories |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Memory | Unexplained feelings of panic | 7 number of memories |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Symptoms - Memory | Intrusive Memories | 7 number of memories |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1 | 11.9 score on a scale | Standard Deviation 2.1 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2 | 11.1 score on a scale | Standard Deviation 2.1 |
Secondary
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit | 0-1 no risk | 3 Participants |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit | 2-3 mild risk | 8 Participants |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit | 4-8 moderate risk | 0 Participants |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit | 9 or more severe risk | 3 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit | 0-1 no risk | 3 Participants |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit | 2-3 mild risk | 8 Participants |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit | 4-8 moderate risk | 0 Participants |
| Patients With PICS | Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit | 9 or more severe risk | 3 Participants |