Trial Outcomes & Findings for CoV-PICS: A Virtual Post-ICU Clinic (NCT NCT04490278)

Last Updated: 2023-03-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

up to 6 months after consent

Results posted on

2023-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	6

Baseline Characteristics

CoV-PICS: A Virtual Post-ICU Clinic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With PICS n=14 Participants 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.
Age, Continuous	62.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Body Mass Index (BMI)	30.4 kg/m^2 STANDARD_DEVIATION 10.8 • n=5 Participants
No comorbidities	3 Participants n=5 Participants
Hypertension	7 Participants n=5 Participants
Diabetes	5 Participants n=5 Participants
Chronic Kidney Disease	5 Participants n=5 Participants
Asthma	2 Participants n=5 Participants
COPD	1 Participants n=5 Participants
Other lung disease	3 Participants n=5 Participants
Cancer	3 Participants n=5 Participants
Hospital length of stay (d)	21 days n=5 Participants
ICU length of stay (d)	11 days n=5 Participants
# of patients on Mechanical Ventilation (%)	7 Participants n=5 Participants
Time on ventilator (d)	10 days n=5 Participants
# of patients on ECMO	0 # of patients on ECMO n=5 Participants
Discharge location (%) Home	8 Participants n=5 Participants
Discharge location (%) Rehabilitation Facility	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - AIM	4.8 score on a scale Standard Deviation 0.31

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - IAM	4.6 score on a scale Standard Deviation 0.69

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Acceptance With COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Visits - FIM	4.7 score on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 1	5.4 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Approximately 60 days after initial visit (scheduling dependent)

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Symptoms - Daily Living - Visit 2	5.8 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 1	11.9 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Approximately 60 days after initial visit (scheduling dependent)

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Systems - Cognitive Visit 2	11.1 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit 0-1 no risk	3 Participants
Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit 2-3 mild risk	8 Participants
Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit 4-8 moderate risk	0 Participants
Post Intensive Care Syndrome (PICS) Systems - Nutrition Initial Visit 9 or more severe risk	3 Participants

SECONDARY outcome

Timeframe: Approximately 60 days after initial visit (scheduling dependent)

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit 0-1 no risk	3 Participants
Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit 2-3 mild risk	8 Participants
Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit 4-8 moderate risk	0 Participants
Post Intensive Care Syndrome (PICS) Systems - Nutrition Final Visit 9 or more severe risk	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With PICS n=14 Participants 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.
Post Intensive Care Syndrome (PICS) Symptoms - Memory Number of Factual memories	106 number of memories
Post Intensive Care Syndrome (PICS) Symptoms - Memory Number Feelings and memories	49 number of memories
Post Intensive Care Syndrome (PICS) Symptoms - Memory Number of delusions	38 number of memories
Post Intensive Care Syndrome (PICS) Symptoms - Memory Unexplained feelings of panic	7 number of memories
Post Intensive Care Syndrome (PICS) Symptoms - Memory Intrusive Memories	7 number of memories

Adverse Events

Patients With PICS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chris Palmer

Washington University

Phone: 314-215-7384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place