DEID -- FLIPCUP FOR DEMO This file contains the metadata, events, and data for REDCap project "DEID -- FLIPCUP FOR DEMO". DEID -- FLIPCUP FOR DEMO 1 1 1 email 0 Copying structure, not data. Participant ID Survey Identifier First Name Last Name Position Position Other Specify Which site do you work at? Email Distribution List Notes Sample Number Complete? Survey Timestamp Contact Information [email_arm_1][first_name] [email_arm_1][last_name] [email_arm_1][position] [email_arm_1][site] [email_arm_1][email]<div class="rich-text-field-label"><p>Contact Information<br /><span style="font-weight: normal;">[email_arm_1][first_name] [email_arm_1][last_name]</span><br /><span style="font-weight: normal;">[email_arm_1][position]</span><br /><span style="font-weight: normal;">[email_arm_1][site]</span><br /><span style="font-weight: normal;">[email_arm_1][email]</span></p></div> Do you have any medical conditions that cause immunosuppression or do you take any medications that suppress your immune system? (known or suspected): Unable to follow up (no phone, will be out of the area in next few months): Unable to have blood drawn Current influenza-like illness Currently pregnant UNIVERSITY OF CALIFORNIA, SAN FRANCISCO CONSENT TO BE IN RESEARCH Study Title: Frontline Provider COVID-19 Underlying Prevalence - FLIPCUP This is a medical research study, and you do not have to take part. The study doctor, Ralph Wang M.D., Charley Murphy M.D., or Aaron Kornblith M.D. from the Department of Emergency Medicine will explain this study to you. If you have any questions, you may ask the study doctor. You are being asked to take part in this study because you are a front line health care professional. In this study, the researchers are collecting blood samples to learn more about COVID-19 sero- positivity. About 300 people will give blood samples for this research. Why is this study being done? Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread internationally and in the US. Front line health care providers have been exposed to coronavirus disease 2019 (COVID-19), with many important consequences: 1) the provider becomes ill; 2) asymptomatic carriers may expose patients and family members to COVID-19; 3) infected providers cannot continue to provide care, resulting in the need for sick call. Being a healthcare worker is considered a risk factor for contracting COVID-19. The emergency department (ED) environment is challenging and may lead to multiple higher risk exposures for COVID-19. We seek to assess the seropositivity of ED and anesthesia (frontline) providers (nurses, physicians, staff) over 4 months to identify independent predictors of infection. The impact of measuring the COVID-19 seropositivity in frontline providers during the pandemic (and identifying independent predictors of infection) will result in an improved estimate of the prevalence of infection among frontline workers and may allow us to identify modifiable risk factors leading to COVID seroconversion. We are using an antibody test called the SARS-CoV-2 IgG assay to assess prevalence and incidence. The use of this test is "investigational" which means it is not approved by the Food and Drug Administration (FDA). The test, however, has an Emergency Use Authorization (EUA) from the FDA, and is the standard test used at UCSF to detect COVID-19 antibodies. What will happen if I take part in this study? If you are eligible for the study and agree to participate you will go to the dedicated study space in the Emergency Department and give a blood sample. There will be 3 visits in total: the first visit, in 2 months, and in 4 months. For each visit, we will draw a tube of blood by sticking a needle in your vein. We will draw one tube of blood, or about 5ml. We will inform you of the result, and the test should result in 4-6 hours. To process your tests in the UCSF Lab you will be given a medical record number in the APEX system if you do not have one set up already. Your results will be available through the patient portal. If your results are positive we will call you the day they are available, usually the same day as they were drawn. If results are negative, we will send you an email. We will answer questions you have about the test results and are available at the test site to discuss results on other days. You are also welcome to call UCSF Occupational Health to discuss your test results privately or ask about other health concerns related to the SARS-CoV-2 test. However, you should not use the results to make decisions related to work, personal life, or family health. There will also be a questionnaire form to complete on demographics, job type and clinical duties, COVID-19 exposure at work and outside of work, and recent symptoms. Each visit will take about 30 minutes. • Study Location: UCSF Parnassus Emergency Department; UCSF Mission Bay Emergency Department What does it mean if my antibody testing is positive? • If your SARS-CoV-2 antibodies are "positive", that may mean that your immune system was exposed to a coronavirus. This could be the SARS-CoV-2 virus (that can cause the disease COVID-19), or a closely related virus such as coronavirus HKU1, NL63, OC43, or 229E. This exposure occurred at some time in the past, and you now have antibodies against it. • If it was the SARS-CoV-2 virus, you may or may not have been sick at the time, as sometimes the body can encounter and fend off the virus without your having ever had symptoms. Or, you could have had an illness that was from SARS-CoV-2 virus, whether or not you knew it at the time. • We are not yet certain what it means to have antibodies against the SARS-CoV-2 virus, in terms of being protected against getting it again. It may mean you have some protection, but that is not certain yet. And if it does offer some protection, we are not sure how long that protection lasts. • Furthermore, we do not know yet whether you could still transmit the infection to others, even if you have antibodies. It is important that you continue to protect yourself and community against SARS-CoV-2 infections through hand hygiene, social distancing, staying home when you are sick and wearing personal protective equipment when caring for patients. • It may even be possible, although unlikely, that the test may indicate you have antibodies against SARS-CoV-2 when you really do not. What does it mean if my antibody testing is negative? If your SARS-CoV-2 virus antibody test is "negative" this could mean one of three things: • It could mean that you have not had the SARS-CoV-2 virus infection recently (in the past few months), or • It could mean that the test fails to identify antibodies, when you actually have them, or • It could mean that you had or even have SARS-CoV-2 now, but your body has not yet had a chance to develop antibodies to it. It usually takes 1-2 weeks to develop antibodies after the onset of illness, but can sometimes take weeks or even longer. Some people may never develop antibodies despite having had an infection. Are there risks? The needle stick may hurt. There is a small risk of bruising and fainting, and a rare risk of infection. Also, there is a potential loss of confidentiality. We plan to protect you from these risks by using trained investigators who are experienced at blood draws. Also, we will protect you from loss of confidentiality by using REDCap, a password protected dataset restricted to study investigators. Medical record results in APEX will be available to you through the patient portal and to your medical providers. Medical records are covered by confidentiality laws and will not be released outside of your care providers without your permission Are there benefits? There are no direct benefits to you from participating in this study. However, this study will help doctors learn about whether front line healthcare workers have been exposed to SARS-CoV-2 in the past." Can I say "No"? Yes, you do not have to donate a blood sample for this study. If you decide not to be in this study you will not lose any of your regular benefits, and you can still receive medical care from UCSF. How will information about me be kept confidential? Participation in research involves some loss of privacy. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total privacy. If you do not have a UCSF medical record, one will be created for you. Your signed consent form and some of your research tests will be added to your UCSF medical record. Therefore, people involved with your future care and insurance may become aware of your participation and of any information added to your medical record as a result of your participation. Your personal information may be given out if required by law. If information from this research is published or presented at scientific meetings, your name and other identifiers will not be used. Information that identifies you will be destroyed when this research is complete. We will do our best to protect the information we collect from you. Information that identifies you will be kept secure and restricted. However, your personal information may be given out if required by law. If information from this research is published or presented at scientific meetings, your name and other identifiers will not be used. Information that identifies you will be destroyed when this research is complete. California regulations require laboratories to report new cases of COVID-19 to the county public health department.. All COVID-19 test results (positive, negative or inconclusive) must be reported. The reports may include details such as: your name, and other identifying information. Information about these new infections is used to track these diseases statewide and nationwide. Other than this required reporting, your results will be treated confidentially by the study staff. Personally identifying information will not be reported to other departments or agencies. For a full list of reportable conditions, see the following link: https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/ReportableDiseases.p df Authorized representatives from the following organizations may review your research data for the purpose of monitoring or managing the conduct of this study: • Representatives of the University of California • Representatives of the Food and Drug Administration (FDA) How will my specimens and information be used? Researchers will use your specimens and information to conduct this study. Specimens and information gathered during this research study will only be used for this study. They will not be shared with other researchers. Are there any costs or payments? You will not be charged for taking part in this study. You will not be paid for taking part in this study. What if I get injured? Tell the study doctor, Ralph Wang if you feel that you have been injured because of being in this research. You can tell the doctor in person or call him at 510-384-9514. Treatment and Compensation for Injury: If you are injured as a result of being in this study, the University of California will provide necessary medical treatment. The costs of the treatment may be billed to you or your insurer just like any other medical costs, or covered by the University of California or the study sponsor, depending on a number of factors. The University and the study sponsor do not normally provide any other form of compensation for injury. For further information about this, you may call the office of the Institutional Review Board at 415- 476-1814. Who can answer my questions about the study? You can talk to the study doctor about any questions, concerns, or complaints you have about this study: ralph.wang@ucsf.edu. Contact the study doctor, Ralph Wang, at 510-384-9514 If you wish to ask questions about the study or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the study, please call the office of the Institutional Review Board at 415-476-1814. CONSENT You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep. You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you. PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled. Participating in this study will have no impact on your work situation or performance reviews. If you wish to be in this study, please sign below. Do you consent to this study? Signature (Consent) Telephone for contact so that we can provide you with updates related to this study Complete? Survey Timestamp Date of Enrollment Date of Birth: Cell phone # Alternate phone # Best method to contact you? Best method to contact you? Best method to contact you? What is your gender? What is your gender? What is your gender? What is your gender? Do you consider yourself to be Hispanic or Latino? (Includes Mexican, Puerto Rican, and Cuban) Do you consider yourself to be Hispanic or Latino? (Includes Mexican, Puerto Rican, and Cuban) Do you consider yourself to be Hispanic or Latino? (Includes Mexican, Puerto Rican, and Cuban) Do you consider yourself to be Hispanic or Latino? (Includes Mexican, Puerto Rican, and Cuban) What is your racial background? Please specify: Unless you have filled out the baseline demographic information above, you will not be able to view the link to the appointment scheduler.<div class="rich-text-field-label"><h3><span style="color: #e03e2d;">Unless you have filled out the baseline demographic information above, you will not be able to view the link to the appointment scheduler.</span></h3></div> Please use the link (to the Acuity scheduling app) below to sign up for an appointment to have your antibody test: WARNING: This link will take you to another web page.  This page will stay open.  Please return here after making your appointment. https://FLIPCUPscheduling.as.me/ AFTER you have made your appointment, please fill out the fields below.  You will receive a confimation email immediately and a reminder email one day prior to your appointment. <div class="rich-text-field-label"><div class="rich-text-field-label"> <p>Please use the link (to the Acuity scheduling app) below to sign up for an appointment to have your antibody test:</p> <p>WARNING: This link will take you to another web page.  This page will stay open.  <span style="color: #e03e2d;">Please return here after making your appointment.</span><br /><br /><a href="https://FLIPCUPscheduling.as.me/" target="_blank" rel="noopener">https://FLIPCUPscheduling.as.me/</a></p> <h4><span style="color: #e03e2d;">AFTER you have made your appointment, please fill out the fields below.  You will receive a confimation email immediately and a reminder email one day prior to your appointment.</span></h4> </div></div> Please specify: Were you able to sign up for an appointment? Appointment Date Appointment Time Why weren't you able to make an appointment? Other reason that you were unable to make an appointment Please arrive at the ACU-2 tent outside the Parnassus Emergency Department at your appointment time. You will fill out a survey about COVID-19 exposure, be registered into Apex, and have your blood drawn.<div class="rich-text-field-label"><p>Please arrive at the ACU-2 tent outside the Parnassus Emergency Department at your appointment time. </p> <p>You will fill out a survey about COVID-19 exposure, be registered into Apex, and have your blood drawn.</p></div> Complete? Survey Timestamp Do you go to UCSF for healthcare? Fever Cough Shortness of breath Sore throat Diarrhea In the past month received a Covid PCR test? If yes, date of covid PCR test: What was the result? Did you receive your covid test at UCSF? Have you traveled in the past month? If yes, have you traveled from outside the US? If yes, have you traveled from high prevalence state (NY, NJ, Connecticut, Detroit, Louisiana)? Have you been diagnosed with COVID-19 based on nasal swab/PCR test? Based on your judgement, how likely are you to have COVID-19 antibodies: Do you live with someone who has been diagnosed with COVID? Date of contact? Have you had contact with a known COVID positive patient? Did you have contact with Covid positive patient without PPE? Do you routinely use PAPR in respiratory codes? Do you routinely use n95 in respiratory codes? Do you routinely use n95 in in high risk patients? Do you routinely reuse n95 masks? Do you use professionally decontaminated PPE? Number of intubations in last month? Number of patients swabbed (NP or OP) in last month? Have you been in a room with receiving nebs in last month? Have you been in a room with receiving positive pressure ventilation in last month? Have you been in a room with receiving CPR in last month? Date/Time that you completed this form Complete? MRN Test Date Test Result Test Result Other Text Test Notes Complete? ED Attending ED Resident ED Nurse ED APP (Advanced Practice Provider) EMT Other Parnassus Mission Bay Both Incomplete Unverified Complete Yes No Yes No Yes No Yes No Yes No Yes No Incomplete Unverified Complete Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked White or Caucasian Black or African American Asian (Asian Indian, Chinese, Filipino, Japanese, Korean, Vietnamese, other) American Indian or Alaskan Native Hawaiian or Other Pacific Islander (Native Hawaiian, Guamanian, or Chamorro Samoan, other) More than one race Other Don't Know Yes No 8/31/2020 9/8/2020 9/14/2020 9/21/2020 7 am 8 am 9 am I'm not free during the available test date/times Study location not convenient Other (specify) Incomplete Unverified Complete Yes No Yes No Maybe Yes No Maybe Yes No Maybe Yes No Maybe Yes No Maybe Yes No Positive Negative Yes No Yes No Yes No Yes No Yes No 0% 1-2% 3-5% 6-10% 11-25% 26-50% 51-75% 76-100% Yes No None 1-3 3-10 >10 Yes No Yes No Yes No Yes No Yes No Yes No None 1-3 3-10 10 None 1-3 3-10 10 Yes No Yes No Yes No Incomplete Unverified Complete Negative Positive Other Incomplete Unverified Complete