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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PICS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Record Review - Inpatient Treatment | Other | Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | up to 6 months after consent |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 months after consent |
| Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Palmer, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine/Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32091533 | Background | Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available. | |
| 32221172 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months after consent |
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6 months after consent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Palmer | Washington University | 314-215-7384 | cmpalmer@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2020 | Feb 9, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2020 | Feb 9, 2022 | ICF_001.pdf |
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| 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. |
|
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 |
| 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. | 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 | 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 | 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 | 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. | up to 6 months after consent |
| Sommer P, Lukovic E, Fagley E, Long DR, Sobol JB, Heller K, Moitra VK, Pauldine R, O'Connor MF, Shahul S, Nunnally ME, Tung A. Initial Clinical Impressions of the Critical Care of COVID-19 Patients in Seattle, New York City, and Chicago. Anesth Analg. 2020 Jul;131(1):55-60. doi: 10.1213/ANE.0000000000004830. |
| 28721340 | Background | Rawal G, Yadav S, Kumar R. Post-intensive Care Syndrome: an Overview. J Transl Int Med. 2017 Jun 30;5(2):90-92. doi: 10.1515/jtim-2016-0016. eCollection 2017 Jun. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| No comorbidities | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Chronic Kidney Disease | Count of Participants | Participants |
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| Asthma | Count of Participants | Participants |
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| COPD | Count of Participants | Participants |
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| Other lung disease | Count of Participants | Participants |
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| Cancer | Count of Participants | Participants |
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| Hospital length of stay (d) | Median | Inter-Quartile Range | days |
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| ICU length of stay (d) | Median | Inter-Quartile Range | days |
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| # of patients on Mechanical Ventilation (%) | Count of Participants | Participants |
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| Time on ventilator (d) | Median | Inter-Quartile Range | days |
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| # of patients on ECMO | Number | # of patients on ECMO |
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| Discharge location (%) | Count of Participants | Participants |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months after consent |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | up to 6 months after consent |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months after consent |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Approximately 60 days after initial visit (scheduling dependent) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 6 months after consent |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Approximately 60 days after initial visit (scheduling dependent) |
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| 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 | Posted | Count of Participants | Participants | Up to 6 months after consent |
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| 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 | Posted | Count of Participants | Participants | Approximately 60 days after initial visit (scheduling dependent) |
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| 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. | Posted | Number | number of memories | up to 6 months after consent |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| 9 or more severe risk |
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| 9 or more severe risk |
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| Title | Measurements |
|---|---|
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| Unexplained feelings of panic |
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| Intrusive Memories |
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