COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: Modern, Convenient and Practical Recovery Care
Phase: NA
Conditions: Post ICU Syndrome
Sponsor: Washington University School of Medicine

 
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RESEARCH PROTOCOL 
 
STUDY TITLE 
COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: Modern, Convenient and 
Practical Recovery Care. 
 
SHORT TITLE 
CoV-PICS Clinic 
 
 
PI Name  Christopher Palmer, MD 
Washington University School of Medicine 
Department of Anesthesiology 
 
 
Version Date: July 6, 2020 
 
August 13, 2020 
 
August 27, 2020 
 
 

 
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1.  SYNOPSIS 
 
Study Title 
COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: 
Modern, Convenient and Practical Recovery Care. 
 
Objective 
To determine if discharged COVID-19 patients with PICS symptoms 
are willing and able to navigate the technology necessary to participate 
in a virtual outpatient clinic (feasibility and acceptance).  To determine 
if a multidisciplinary group of professionals, familiar with PICS, are 
able to interpret information obtained from virtual visits and patient 
self-reported surveys to make recommendations for future care based on 
baseline and changes in patient symptoms over time (feasibility).  To 
determine the ease of receiving and receptiveness of primary care 
physicians to a summary of clinic recommendations (feasibility and 
acceptance).  To determine if the PICS symptoms and patient 
characteristics of patients with an ICU stay due to COVID-19 are 
similar to those reported in the literature of non-COVID-19 patients.  
 
 
Study Period 
Planned enrollment duration: Aug 2020 – Feb 2021 
 
Planned study duration: Aug 2020 – Aug 2021 
 
Number of Patients 
 
80, adult (minimum age 18, no maximum) 
Study Treatment  
 
None 
Study Design 
 
Observational feasibility trial 
Inclusion and 
Exclusion Criteria 
Inclusion Criteria:  
1. Patients who are at least 18 years of age  
2. COVID-19 diagnosis with a stay in the intensive care unit at BJH 
3. Missouri resident  
 
Exclusion Criteria:  
1.  Severe cognitive deficits or dementia prior to hospitalization  
2.  Long-term resident of a skilled nursing facility prior to admission  
3.  Non-English speaking (will not have an interpreter available)  
4.  Hospice or Comfort Care at discharge  
5.  No plans to return to some degree of independent living at the time 
of discharge  
6. Pregnant or a prisoner at the time of discharge  
7.  Blind or deaf  

 
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If during the consent process if it is determined the patient will not have 
a home internet connection or smartphone access for the virtual clinic; 
or displays the inability to use either a computer or phone for virtual 
appointments, they will also be excluded from enrollment. 
Measurements 
Primary outcomes:  
1. Patient adherence and determination of feasibility and acceptance 
with the virtual clinic and telehealth visits based on the FIM® 
(feasibility of intervention measure), IAM® (intervention 
appropriateness measure) and the AIM® (acceptance of intervention 
measure)  
2. Patient attendance record 
3. Number of on-time arrivals to the virtual visit 
4. Number of patient successfully completed online questionnaires after 
initial training. 
5. Patient primary care or clinic physician feedback using the tools in #1 
and open ended comments.  
 
 
Secondary outcomes: (to compare patient characteristics to historical 
non-COVID-19 patients with PICS) 
1. ICU Memory Tool® (measures recall and aids in our understanding 
of the quality of life)  
2. PROMIS®29 Profile (measures anxiety, depression, fatigue, pain, 
physical function, sleep and ability to participate in social roles),  
3. MOCA-5 minute® (measures cognitive function),  
4. Katz and Lawton® (measures activities of daily living),  
5. PG-SGA short form® (screens for malnutrition risk),  
6. Five-time sit-to-stand, and Two-minute step test.26-31  
Statistical 
Methodology 
Descriptive statistics will be used to summarize the data.  Continuous 
variables will be reported as medians and interquartile ranges or means 
and standard deviations as appropriate.  Categorical variables will be 
reported as frequencies and percentages. Changes in the scores or times 
of the ICU Memory Tool®, PROMIS®29 Profile, MOCA-5 minute, 
Katz and Lawton®, PG-SGA short form®, Five time sit-to-stand and 
Two-minute step test, from hospital discharge to 3- and 6-month post 
discharge will be estimated using the Wilcoxon Signed Rank Test (non-
parametric alternative to t-test) and compared across different 
categorical variables (e.g. age, gender, discharged directly to home, 30-
day readmission) using ANOVA and continuous variables (e.g. 
APACHE IV, ICU length of stay) using ANCOVA.   
 
A consensus sample would be optimal in this feasibility study (all 
patients meeting criteria consented and participated), however since that 

 
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constitutes the agreement by the recipient that no unpublished information contained herein will be published or disclosed without 
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Page 4 
is unlikely, a convenience sample will be used. The future of patients 
with COVID-19 disease requiring ICU admission is uncertain.  A 
conservative estimate of 50% of these patients will develop PICS. In the 
first month at BJH, 29 patients were discharged from the ICU.  This 
translates into approximately 15 patients per month. Although this 
number may increase or decrease due to uncertainties surrounding the 
disease. Previous studies (see literature review) suggest care for PICS 
should begin within 12 weeks of discharge. Therefore once IRB 
approval is obtained, patients discharged within the past 10 weeks will 
be screened for possible participation. A post-hoc power analysis will be 
done. 
 
 
 
2.  STUDY PROTOCOL  
 
2.1 Background and Significance 
 
Background:  
Coronavirus disease 2019 (COVID-19) is a highly contagious virus transmitted via respiratory 
secretions and was established as a pandemic on March 11, 2020.1 The severity of the disease ranges 
from asymptomatic/mild (81%), to severe requiring oxygen (14%) and critical (5%) which requires 
intensive care unit (ICU) admission, ventilation and life support.2 Two-thirds of these severe cases 
will develop the most severe manifestation of the disease, acute respiratory distress syndrome 
(ARDS).3 Various epidemiologic reports show that the greatest mortality and morbidity risks concern 
frail and vulnerable people, in particular the elderly, and patients who suffer from multiple co-
morbidities or chronic diseases (mainly hypertension, diabetes, cardiovascular disease, chronic, 
respiratory disease, immune compromised status).  Patients requiring a stay in the ICU often have a 
considerably longer length of stay (LOS) than the typical ICU patient. At Barnes-Jewish Hospital 
(BJH) the typical LOS for an intubated ICU patient with COVID-19 disease is 10-12 days, whereas a 
non-COVID-19 medical ICU patient is 3-4 days. Thus far, the greatest attention has been paid to 
strategies to control contagion diffusion and life-saving measures for these critically ill infected 
patients.  It is now time to focus on the inevitable long-term consequences of surviving COVID-19 
disease.  This feasibility study will provide information not only regarding the long-term sequelae of 
COVID-19 disease, but also how to structure future care with a primary emphasis on telehealth, both 
of which may be important if society is faced with another highly contagious disease.  
 
The patients that survive will likely suffer from secondary physical, cognitive and mental 
impairments due to their prolonged stay in the ICU.4,5 Together, these components comprise the Post 
Intensive Care Syndrome (PICS).4 PICS purportedly affects 50 – 70% of ICU survivors which may 
develop during their stay or after discharge and it is estimated one-third of these survivors will die 
within a year.4,5  Post COVID-19 patients may be at increased risk of PICS due to a prolonged period 
of respiratory distress and immobility along with the potential of lung fibrosis and cardiovascular 

 
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deconditioning. In addition, unlike other patients with PICS, the survivors of COVID-19 may also 
find themselves facing distorted human relationships and social fabric within a changing economic 
picture, which may compound their mental health symptoms.5 The COVID-19 pandemic disease 
surge will create an unprecedented number of ICU survivors vulnerable to PICS in the upcoming 
months, generating a major public health issue.  
 
It is imperative as a health system we determine multiple avenues to address the needs of these 
COVID-19 survivors. 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. This research will examine the feasibility, acceptance and potential impact of 
a multi-professional telehealth ICU recovery care platform in addressing the needs of discharged ICU 
patients with COVID-19 disease from the viewpoint of the patient, the primary care physician and 
clinic provider. These findings will advance our understanding of the ability to use telehealth to 
provide care in an environment of patient isolation, as well as to those who may have been 
discharged with suboptimal inpatient education.    
 
 
2.1.1 Preliminary Data 
Although some evidence exists regarding the characteristics of inpatients with COVID-19 disease, it 
is far from robust.  In addition, it is not clear what staff to inpatient interactions, such as frequency of 
therapy sessions or inpatient nursing education, were forgone due to the risk of viral contamination 
and need to preserve personal protection equipment.  A Washington University IRB approved 
(#202005039) observational study at BJH will add to the COVID-19 body of literature on these 
topics and some of the pertinent data obtained will be used in the interpretation of results of the 
proposed study herein.  Evidence regarding long-term complications of COVID-19 disease is lacking, 
however insights from PICS may provide a roadmap for the future care of these patients.  It is highly 
likely, COVID-19 patients will suffer from similar physical, cognitive and mental health issues long-
term.6,7  
 
The physical impairments associated with PICS are believed to stem from ICU acquired weakness 
(ICU-AW) which is a combination of polyneuropathy, myopathy, neuromyopathy and muscle 
deconditioning.6  Patients with PICS are reported to have poor mobility, frequent falls and a dramatic 
loss of independence with activities of daily living (ADLs).8 A study by Borges et. al. compared 72 
patients with sepsis/septic shock to a healthy control group.  The patients admitted to the ICU had a 
substantial reduction in physical activity, exercise capacity and muscle strength at 3 months post 
discharge.9 An evaluation of 109 ARDS patients, demonstrated that although there was an 
improvement in the six-minute walk test at 12 months, the results were still only 66% of predicted 
distance and only 49% of the patients had returned to work.10 These findings were confirmed in 
another study which found 69% of patients with PICS were still restricted in performing ADLs and 
50% had not returned to work 12 months after discharge.11   
 
In addition to long lasting physical detriments, new or worsening impairments in cognitive 

 
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constitutes the agreement by the recipient that no unpublished information contained herein will be published or disclosed without 
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function persist months to years after ICU discharge and are also associated with decrease ability to 
perform ADLs, as well as, reduced quality of life.12,13 There is strong evidence that patients with 
delirium while in the ICU may suffer from cognitive impairments long after they are discharged.6 
Delirium is a common condition resulting from critical illness. This is particularly true in patients 
who require increased sedation and prone positioning to improve oxygenation, such as COVID-19 
patients with ARDS. While receiving these medical interventions, patients often are unable to have 
clear memories leading to altered and sometimes frightening delusions from delirium.14,15   
 
Anxiety, post-traumatic stress disorder and depression (70%, 10-50%, and 30%, of survivors 
respectively) are the major mental illnesses noted in ICU survivors 12 months after discharge.16-18 
Theoretically, these percentages may be even higher in patients with COVID-19 disease who may 
experience exacerbated feelings of emptiness, due to separation and isolation from family and 
friends, a breakdown of their social network, as well as the uncertainty about their diagnosis.  
 
Prevention of PICS includes the incorporation of the ABCDEF bundle (assessment, prevention and 
management of pain; both spontaneous awakening and breathing trials; choice of analgesia and 
sedation; coordination of care and communication; delirium assessment, prevention and management; 
early mobility and exercise; and family engagement), widely known as the bundle that addresses the 
risks of sedation, delirium and immobility.19 Both inactivity and malnutrition may exacerbate ICU-
AW through skeletal muscle mass, strength and function loss. ICU diaries completed by staff and 
family members for the patient provide a description of experiences during ICU care. The diary may 
help to prevent PICS by improving the orientation of the patient and alleviating anxiety, depression 
and PTSD symptoms.20  
 
Although individual symptoms of PICS have been reported over the past decade, PICS first became 
recognized in 2015.17  Often signs and symptoms of PICS do not manifest until the patient has 
returned home, requiring evaluation and treatment in the outpatient setting. A wide variety of follow-
up strategies to prevent/limit the impairments associated with PICS for ICU survivors have been 
examined which include: communication of care between the ICU team and primary provider, peer 
support groups, follow-up phone-calls from the ICU staff to patient, and scheduled in-person 
consultations.21 There has also been the establishment of PICS outpatient clinics to attempt to manage 
this complex patient population. The goals of these clinics have been to improve recovery, decrease 
the cost burden on the healthcare system and improve the patient’s quality of life.22 
Unfortunately, very few outpatient PICS clinics currently exists and those that do are generally in 
metropolitan areas.  However, according to the American Hospital Association approximately 80% of 
ICU beds are located in community hospitals, suggesting these clinic may not be easily accessible by 
the majority of patients who need them (https://www.aha.org/statistics/fast-facts-us-hospitals). 
 
Services offered and clinical professionals available may vary from clinic to clinic.  Most have a 
medical director specializing in PICS and nursing support.  Other professionals may include some 
combination of a neuropsychologist, social worker, pharmacist, physical therapy, occupational 
therapy, case manager and dietitian.  In clinics with limited professionals, services include the patient 
evaluation and then coordination of care with referrals to primary care, subspecialty services, 

 
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constitutes the agreement by the recipient that no unpublished information contained herein will be published or disclosed without 
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physical and occupational therapy as needed.  A review of 30 clinics demonstrated the majority were 
limited to physician and nurse interactions while incorporating patient self-evaluation tools.21  
Most patients returned for their first clinic visit within six to twelve weeks after hospital discharge, 
although some initiated visits within 3 weeks21.   
 
Unfortunately, not all PICS outpatient clinics are widely utilized. Some authors report only 20-50% 
of patients discharged from the ICU suffering from symptoms, will seek follow-up care at a PICS 
clinic.23,24 For example, in a single center study, 34 discharged ICU patients demonstrated significant 
declines in mobility (p=0.026), ADLs (p<0.001) combined with increased anxiety/depression 
(p=0.048), yet under half of them sought follow-up care.24 When asked why they were not accessing 
healthcare services the main reasons included: unclear how to obtain referral, unable to afford the 
service, and lack of physical strength or transport to get to the clinic. PICS patients often suffer from 
financial difficulties due to the inability to return to work, which may make it more difficult for them 
to travel to a clinic.24 However, like other patients they want to get better.  Interviews of 39 adult 
critical illness survivors revealed the following core patient priorities during recovery: going home, 
improving mobility, participating in self-care, restoring physical and psychological health, and 
resuming previous roles and routines.25  
 
Discharged patients with COVID-19 disease may experience increased challenges with transportation 
and treatment at an “in-person” clinics due to current restrictions in place for public and healthcare 
worker protection.   
 
 
2.2 Objective 
 
• Evaluate discharged ICU COVID-19 patients’ involvement in, and acceptance with virtual 
CoV-PICS clinic visits.    
• Test the design of a mutli-professional telehealth outpatient CoV-PICS clinic for effective 
care processes that evaluate impairments in physical, cognitive and mental health function in 
patients with COVID-19 disease. 
• Determine the feasibility and acceptance of Primary Care Physicians regarding information 
provided and communication process from the CoV-PICS clinic.  
• Determine if the PICS symptoms experienced by COVID-19 patients are similar to 
historically reported symptoms in non-COVID 19 patients with PICS.  
 
2.3 Patient Selection 
 
Patients who are +COVID-19 with a stay in the ICU. This screening list (name, medical record 
number) will be provided by the PI for (IRB#202005039) study: “The Effects of COVID-19 on 
Nursing Indicators, Delirium, Nutritional Status and Functional Mobility”.  The research coordinator 
will review the medical record for exclusion criteria, if none exist, and a contact phone number is 
available, the research coordinator will complete a phone screen (see attached).  
 

 
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2.3.1 Inclusion Criteria 
 
1. Patients who are at least 18 years of age  
2. COVID-19 diagnosis with a stay in the intensive care unit at BJH  
 
2.3.2 Exclusion Criteria 
1.  Severe cognitive deficits or dementia prior to hospitalization  
2.  Long-term resident of a skilled nursing facility prior to admission  
3.  Non-English speaking (will not have an interpreter available)  
4.  Hospice or Comfort Care at discharge  
5.  No plans to return to some degree of independent living at the time of discharge  
6. Pregnant or a prisoner at the time of discharge  
7.  Blind or deaf  
If during the consent process if it is determined the patient will not have a home internet connection 
or smartphone access for the virtual clinic; or displays the inability to use either a computer or phone 
for virtual appointments, they will also be excluded from enrollment. 
 
2.4. Study Design 
 
Observational feasibility.  To determine if discharged COVID-19 patients with PICS symptoms are 
willing and able to navigate the technology necessary to participate in a virtual outpatient clinic.  To 
determine if a multidisciplinary group of professionals, who are licensed in the state where the 
participant lives, familiar with PICS, are able to interpret information obtained from virtual visits and 
patient self-reported surveys to make recommendations for future care based on baseline and changes 
in patient symptoms over time.  To determine the ease of receiving and receptiveness of primary care 
physicians to a summary of clinic recommendations.  To determine if the PICS symptoms and patient 
characteristics of patients with an ICU stay due to COVID-19 are similar to those reported in the 
literature of non-COVID-19 patients.  
 
 
2.4.1 Study Procedures 
 
Study Procedures – Patient and PCP involvement 
Consent  
Verbal consent is being sought. RC will be in a private space and obtain consent.  
All visits with the patient will be “virtual”.  
Chart Review 
Once patient consent is obtained, a prospective or retrospective chart review 
(depending on availability of research team members) will be conducted to obtain 
several data points (see attached).    
Day 1 
RC: Add patient to enrollment log:  Study ID, first name, 3 letters of last name, 
MRN#, hospital discharge date, date returned home (if different from discharge 
date), and patient preferred email and phone number.  If patient consents, PCP 
name, office phone number and fax number.  This will be in a password protected 
Excel file available only to research team members.  
Day 1 
RC: Document date/time of consent, upload pdf of note to RedCap 

 
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Day 1  
 
RC: Patient emailed a copy of the verbal consent, as well as, an information sheet, 
including a timeline for the study and “what to expect” and “what not to expect”. 
 
What to expect: Timeline for study, Initial surveys, follow up surveys at 3 and 6 
months, team visits (when – at minimum every 12 weeks; time commitment – 60-
75 minutes), bi-weekly touch base email by RC s, individual visits with team 
members if warranted, summary of team recommendations after each visit, 
potential contact from PCP (if patient consented for information to be shared) and 
contact information for RC and PI for any questions or concerns throughout the 
study period.  All providers engaging in telehealth visits will be licensed in the 
state were the participant lives. 
 
What not to expect:  Clinic physicians or other providers to write prescriptions, 
order lab tests or perform any treatments  
Day 1-2 
 
Week 10 post 
initial visit 
And 
Week 22 post 
initial visit 
 
 
RC: If patient not enrolled in MyChart or has forgotten how to access, call patient 
and walk them through obtaining access.  Direct link (attached to the patient’s 
study ID) will be emailed or texted (per patient preference) to access the following 
surveys, requesting one week turn-around time:   
ICU Memory Tool® (measures recall and aids in our understanding of quality of 
life) 
PROMIS®29 Profile (measures anxiety, depression, fatigue, pain, physical 
function, sleep and ability to participate in social roles) 
MOCA-5 minute® (measures cognitive function) 
PG-SGA short form® (screens for malnutrition risk) 
Day 2-9 
Week 11 and 
Week 23 post 
initial visit 
RC: Will send form email from PI to PCP (if patient agreed to share information) 
providing an overview of the study (see attached) 
RC will obtain notice from RedCap when surveys opened. RC will check 
completeness of survey responses.  If surveys not completed within 5 days, send 
reminder email. If not completed in 7 days, call patient offering to administer 
surveys over the phone.    
Day 11 
Week 11 and 
Week 23 post 
initial visit 
RC: If patient does not complete surveys within 7 days of receipt and has not 
responded to phone calls; considered an enrollment fail (start of study) or 
withdrawal from study (repeat surveys), document on enrollment log.  
Day 2-11 
Week 11 and 
Week 23 post 
initial visit 
RC: If surveys completed, send thank you email.  Email and/or call patient to 
schedule first virtual visit.  Email link to research team members for them to 
review responses in RedCap.  
Day 9 – 18 
Week 12 and 
Week 24 post 
initial visit 
RC: Schedule initial 60-75 minute virtual assessment based on MD schedule. 
Email all team members to obtain availability in non-physician visit time. Send 
outlook calendar appointments to team members. All providers engaging in 
telehealth visits will be licensed in the state were the participant lives. 
 
1-2 days before  
virtual team visit 
 
RC: Send reminder email to research team members who will be on the visit. Send 
agenda for call – member/time slot. Send instructions/link for team members to 
join the virtual visit. Email the patient the instructions on how to access the virtual 
appointment in MyChart or the HIPPA approved WashU ZOOM link.   

 
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30 min before 
each virtual team 
visit 
RC: Email/call patient to address any concerns/questions regarding accessing 
virtual visit.  RC will be “host” of the link for the visit. 
Time of virtual 
team visit 
RC: Send text to research team that patient has successfully entered the virtual 
visit.   
During virtual 
team Visit 
RC will function as timekeeper – send “chats or texts” to research team members 
to keep them on time.  Team members will speak one at a time, with other 
members on mute.  MD will start with introduction and overview that summary of 
recommendations after the visit will be sent to the patient’s PCP and the patient, 
emphasizing the patient and the PCP will be responsible for implementing and 
monitoring recommended treatments. Each professional will follow with 
introduction/any additional questions.  The physical therapist and occupational 
therapist will go last to complete the following if the patient agrees/is able: 
Katz and Lawton® (measures activities of daily living) 
Five time sit-to-stand 
Two minute step test 
All providers engaging in telehealth visits will be licensed in the state were the 
participant lives. 
1-3 days post 
virtual team visit 
Team Members: responsible for documenting in EPIC their note/summary within 2 
days of visit 
RC: Email patient summary of recommendations are available in MyChart for 
patient to access.  Email PCP that summary is available in MyChart, or fax 
summary if PCP does not have access to MyChart.  Clinic MD may choose to 
contact PCP personally regarding patient evaluation if they deem necessary.  
2, 4, 6, 8, 10 
weeks post initial 
and second 
virtual team visit 
RC: Phone call to patient – What recommendations have been implemented?  Any 
questions for any member of the research team?  Any team member: may touch-
base with the patient or treating professional (home physical therapist) if 
recommendations have been implemented by the PCP (e.g. physical therapy, 
change in medication, change in diet) to determine if they have any questions 
regarding the treatment initiated.   If team member desires a virtual visit with 
patient – RC will host.  
Week 25 - 26 
RC: Send final surveys to patient via link.  An email with a link will also be sent to 
their PCP – at the start of their survey a statement will be made clearly stating if 
they complete the survey they are consenting to the study.  The final survey tools 
sent will include: FIM® (feasibility of intervention measure), IAM® (intervention 
appropriateness measure) and the AIM® (acceptance of intervention measure).  If 
surveys not completed within 5 days, send reminder email. If not completed in 7 
days, if patient – phone call offer to administer surveys over the phone; if PCP 
send 2nd email reminder. If the PCP does not complete, will consider denial to 
participate (document on enrollment form).  
Week 25 - 26 
RC: Once final surveys are completed email patient informing them their 
participation in the study is now completed, thanking them for their time and 
offering any final comments regarding the feasibility of the clinic may be emailed.  
 
RC: research coordinator, PI: principle investigator, PCP: primary care physician 
 
 

 
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2.4.2 Minimization of Bias 
 
There will be no specific gender or ethnic background for enrollment.    
 
2.4.3 Pre-Study Period 
 
2.4.4 Study Period 
 
Methods: 
 
2.4.6 Observations and Measurements 
 
2.4.6.3 Primary Outcome Measures 
Primary outcomes:  
1. Patient adherence and determination of feasibility and acceptance with the virtual clinic and 
telehealth visits based on the FIM® (feasibility of intervention measure), IAM® (intervention 
appropriateness measure) and the AIM® (acceptance of intervention measure)  
2. Patient attendance record 
3. Number of on-time arrivals to the virtual visit 
4. Number of patient successfully completed online questionnaires after initial training. 
5. Patient primary care or clinic physician feedback using the tools in #1 and open ended comments.  
 
 
2.4.6.4 Secondary Outcome Measures 
Secondary outcomes: (to compare patient characteristics to historical non-COVID-19 patients with 
PICS) 
1. ICU Memory Tool® (measures recall and aids in our understanding of the quality of life)  
2. PROMIS®29 Profile (measures anxiety, depression, fatigue, pain, physical function, sleep and 
ability to participate in social roles),  
3. MOCA-5 minute® (measures cognitive function),  
4. Katz and Lawton® (measures activities of daily living),  
5. PG-SGA short form® (screens for malnutrition risk),  
6. Five-time sit-to-stand, and Two-minute step test.26-31 
 
2.4.6.5   Statistical Methods 
Descriptive statistics will be used to summarize the data.  Continuous variables will be reported as 
medians and interquartile ranges or means and standard deviations as appropriate.  Categorical 
variables will be reported as frequencies and percentages. Changes in the scores or times of the ICU 
Memory Tool®, PROMIS®29 Profile, MOCA-5 minute, Katz and Lawton®, PG-SGA short form®, 
Five time sit-to-stand and Two-minute step test, from hospital discharge to 3- and 6-month post 
discharge will be estimated using the Wilcoxon Signed Rank Test (non-parametric alternative to t-
test) and compared across different categorical variables (e.g. age, gender, discharged directly to 

 
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constitutes the agreement by the recipient that no unpublished information contained herein will be published or disclosed without 
prior written approval. 
 
DoCTR 
   
 
 
 
Page 12 
home, 30-day readmission) using ANOVA and continuous variables (e.g. APACHE IV, ICU length 
of stay) using ANCOVA.   
 
2.4.6.6   Sample Size 
A consensus sample would be optimal in this feasibility study (all patients meeting criteria consented 
and participated), however since that is unlikely, a convenience sample will be used. The future of 
patients with COVID-19 disease requiring ICU admission is uncertain.  A conservative estimate of 
50% of these patients will develop PICS. In the first month at BJH, 29 patients were discharged from 
the ICU.  This translates into approximately 15 patients per month. Although this number may 
increase or decrease due to uncertainties surrounding the disease. Previous studies (see literature 
review) suggest care for PICS should begin within 12 weeks of discharge. Therefore once IRB 
approval is obtained, patients discharged within the past 10 weeks will be screened for possible 
participation. A post-hoc power analysis will be done. 
 
2.5 Management of Intercurrent Events 
 
 
2.5.1 Adverse Experiences 
 
No adverse events are expected in this non-interventional study.  
 
2.5.2 Premature Discontinuation 
 
Subjects will be withdrawn if the investigator decides that discontinuation is in the best interest of the 
subject, inactivity by the subject or the subject requests withdrawal from the study. 
 
2.5.3 Potential Risks 
 
Minimal risk, only breach of patient confidentiality 
 
2.5.4 Procedures to Minimize Potential Risks 
 
The study offers minimal risk to the patient as no interventions will take place.  The following 
measures will be used to minimize breach of confidentiality risk: minimum necessary data collection, 
all patient data will be either be in RedCap (without any patient identifiers) or in a password 
protected Excel file.  Only research team members will have access to this data.  Any patient 
identifiers will be discarded per WashU protocol as soon as possible within the context of the study.  
All virtual visits will occur on a secure site via MyChart or WashU HIPPA approved Zoom.  Any 
transmitted electronic from will be done using recognized security for electronic submissions.  All 
providers engaging in telehealth visits will be licensed in the state were the participant lives. 
 
2.5.5   Data and Safety Monitoring Plan 

 
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Based on the small size and relatively low risk nature of the protocol, only a second team member not 
involved in data collection (statistician) will perform the duty of data and safety monitoring.  A 
review of 10% of the records added will occur every 3 months.  
 
3.  HUMAN SUBJECTS RESEARCH 
 
3.1 Protection of Human Subjects 
 
The study will be conducted under appropriate Washington University Institutional Review Board 
protocols and consent forms approvals.  The study will be conducted under the supervision of the PI, 
a Board-Certified and GCP-certified anesthesiologist, and a mentor with several years experience in 
the conduct of human volunteer studies. 
 
3.2 Sources of Materials 
 
Review of the patient’s electronic medical record (EPIC) may occur anytime between when the 
patient consents to study conclusion.  Responses to surveys will be collected as outlined in the study 
procedure above.  
 
3.2.1 List of Protected Health Information Collected for Study 
 
See data attachment. 
 
3.2.2 Data Management 
 
All materials will be stored in a secured environment (password protected) – either RedCap or a 
password protected Excel file.  Access will be limited to research team members only.  
 
3.3 Recruitment and Informed Consent 
 
Patients who are +COVID-19 with a stay in the ICU will be screened.  A list of patients that meet 
these criteria that includes the patient’s name and medical record number will be provided by the PI 
for (IRB#202005039) study: “The Effects of COVID-19 on Nursing Indicators, Delirium, Nutritional 
Status and Functional Mobility” (see attached letter).  The research coordinator will review the 
medical record for exclusion criteria, if none exist, and a contact phone number is available, the 
research coordinator will complete a phone screen (see attached).  The research coordinator will call 
in the patient from a private room.  If the phone screen demonstrates the patient has potential signs 
and symptoms of PICS and the mental capacity to answer questions, a verbal consent will be sought 
(see attached).  Prior to consent the patient will be asked if they need to move to a private area or if 
the prefer to invite family members to present.  Verbal consent is being sought as the current study 
does not include any patient intervention.   
 
 

 
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3.4 Potential Benefits of the Proposed Research to the Subjects and Others 
 
Participants 
The study team consists of team members with expertise in the area of critical care and 
therefore may be more likely to recognize presence of, or risk of developing, post-intensive care 
syndrome (PICS) symptoms.  Sharing this multi-professional expertise with the patient and their PCP 
or clinic physician may allow for a more timely and holistic approach to follow-up care. Patients, 
PCPs and clinic physicians will have an increased awareness of PICS.  
 
Society 
The characteristics of the symptoms displayed in this sample of COVID-19 patients can be 
compared to those of non-COVID-19 patients as previously reported in the literature.  This may 
provide insight for future care of patients since this is a new disease and so little is known. A large 
cohort of ICU survivors are likely to be at high risk for PICS.  The potential to treat or prevent this 
complication via a virtual approach could have a large public health impact. 
 
 
3.5 Inclusion of Women 
 
As a matter of operational policy, our studies of volunteers routinely and deliberately include 
equivalent numbers of women and men. To ensure sufficient enrollment of women, we typically 
close enrollment to men once their quota has been filled.  This approach has been highly successful. 
However, the nature of the current study precludes enrollment of a set number of female or male 
patients since the main criteria for inclusion is +COVID-19 admission with an ICU stay.  
 
3.6 Inclusion of Minorities 
 
All of our studies actively encourage the participation of minorities in the research.  Our minority 
recruiting typically matches the demographic composition of the Washington University community 
from which subjects will be recruited (78% white, 21% Black, <1 % Hispanic). However, the nature 
of the current study precludes enrollment of a set number of minorities since the main criteria for 
inclusion is +COVID-19 admission with an ICU stay.  
 
 
3.7 Inclusion of Children 
 
Children <18 yr will not be studied in this study 
 
4.  REFERENCES 
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