Author: MAMTA JAIN
Ensuring equitable access to clinical trials
Although many at UT-Southwestern worked together to reduce barriers to opening clinical trials related to COVID-19, obstacles to implementing still existed. To provide access to potential therapeutic medications through a clinical trial, we needed to obtain consent from the participant. We usually do this through an in-person process with the investigator, coordinator, and the patient, but we could not enter patients’ rooms because there was not enough personal protective equipment (PPE). We received permission to obtain electronic consent by DocuSign, a process ideal for those who have an email and cell phone.
In our county hospital, Hispanic patients accounted for 90 percent of the admissions for COVID-19, and often did not have cell phones or an email address. Instead, we used the hospital’s tubing system to send a paper copy of the Spanish-language consent form to the nursing station. The patient’s nurse could pick up the paperwork there, and bring it to the patient to read. We employed bilingual coordinators to help facilitate coordination and translation of complex medical information from the investigator to the patient.
After explaining the study and obtaining permission to proceed, we then obtained a digital signature by DocuSign. We had the patient’s nurse take a donated iPad into the room of the patient, and sent the DocuSign document to an email account we created for the study. The coordinator would then walk the patient through the process of signing their name on the consent form on the iPad. After the investigator signed the consent, DocuSign would then send a completed signed copy to the coordinator, who printed the written consent and scanned it to the patient’s record. Through this elaborate, time-consuming effort, we were able to provide access to clinical trials to uninsured Hispanic patients who faced both language and digital barriers. We promoted health equity to uninsured members of the Hispanic community who were hardest hit by the COVID-19 pandemic in our region.
In our University Hospital, we were able to go to patients’ rooms (either in the ICU or on the floor) but not enter them, due to PPE shortages. If the patient did not have an email, we could communicate by phone or a video conferencing application on the hospital’s computer system. Together with the nurse, who was in the room with the patient, we explained the study, answered questions, had the patient sign their consent, and the nurse sign as the witness. The nurse then brought the consent to the window or door so a member of the research team could take a photograph. Subsequently, we obtained iPhones, which the nurses used to take a picture of the consent and upload it directly into the chart. In those studies that required a physical exam, the nurse was able to record heart and lung sounds through a Littman stethoscope, which the investigator listened to from the hospital’s computer system. We have used technology and teamwork to find innovative ways to perform research procedures during this unprecedented time. We have tried to build trust with our patients and our staff by working with them to provide access to therapies for COVID-19.
Mamta Jain is a board-certified Infectious Disease specialist and Professor of Medicine at UT Southwestern Medical Center. Her goal is to provide access to novel therapies through clinical trials. She has focused her efforts in medically underserved populations to help provide access to treatment for infectious such as HIV, hepatitis C, influenza, and now COVID-19.