Practice-Based Primary Care Clinical Research During the COVID Pandemic.

Abstract

Practice-Based Primary Care Clinical Research During the COVID Pandemic Barbara P Yawn Acknowledgments. Thank you to the investigators, research staff and Practice Based Research Network (PBRN) staff and practices in the CAPTURE trial. Funding. This work is funded by the lung division of the National Heart Lung and Blood Institute. All clinical research became challenging early in 2020 with the first surge of the SARS-CoV-2 (COVID) pandemic. All multi-centered academic clinical trials faced many challenges. Our study based not in academic centers or practices, but in primary care practice-based research networks (PBRNs) seemed to have added layers of challenges to identify, understand, and overcome. Our project enrolled primary care practices and then patients directly in their primary care practices for a single in-person visit. Before COVID, the clinical staff of the practices were invited to a lunch session that provided a 45-minute online review of the clinical topic. Patient participants completed the questionnaires and spirometry and peak flow testing required for this study at the time of their visit to their primary care office for another reason. 12-month follow up was done with an online, telephone or mailed patient survey, and from review of the past 12 months of health care use from participant's medical record abstraction and designed to be completed in about 50% of participants. Beginning in early March 2020, the practice sites and all of our practice-based research networks halted all research. Over the next few months, the sites allowed some COVID-related research to begin or resume. Our study did not fit that category. Over the summer months of 2020, some other studies that could be accomplished via virtual interactions like telephone or online surveys were allowed to restart. We did not meet that standard either since we need spirometry and peak flow testing. Most of our work had to be refocused from completing enrollment to identifying safety protocols and procedures for the consent and questionnaires. The spirometry and peak flow procedures, which were considered a nebulizing procedure, were a very large concern in the summer of 2020. The primary care clinics saw them as potentially viral spreading procedures. We were working with six PBRNs spread around the country with different periods of "surge" and very different oversight of practice-based primary care research. In some PBRNs, the requirements for safety were set by the PBRN's affiliated academic medical center. For other PBRNs, requirements were set, or also set, by regional health care systems. All practices needed to work with the local practices to understand their concerns, educate them on levels of risk, and address safety needs unique to that site. Obtaining personal protective equipment (PPE) was difficult since our study was not being completed in the hospital setting and was often not directly associated with an academic medical center. Once we obtained PPE through the AMA, SGIM, and AAFP programs, we needed to work on "fit testing" for the N95 masks, which is not readily available at all primary care practices or PBRNs (e.g., those based in rural areas). We needed to develop "cleaning and re-use" policies that fit with the academic and CDC guidance but were realistic for our broad spectrum of sites. [End Page 22] One approach that appeared to be acceptable to several primary care practices and research oversight groups was to offer visits virtually. While virtual enrollment and visit completion would have been a nice solution, our academic pulmonology investigators and the experts on our DSMB did not feel that at home pre- and postbronchodilator spirometry could be done with sufficient accuracy to meet the needs of our study. So, we developed the concept of "mixed" research visits—part virtual and part in person. Virtual visits, however, required a change in consenting to online or e-consent. For many sites, the use of e-consent was a barrier requiring new formats, new tools, and in some cases, extensive work with local IRBs to approve not only specific e-consent tools but also garner support for the concept of e-consent, even for our minimal risk study. IRBs expressed concerns that potential participants would not understand or be engaged...