Important changes—impact of COVID on trial procedures
RECRUITMENT
Patient recruitment occurred from January 2018 to August 2019. The first patient visits were held on September 2018 to August 2019. The 6-month follow-up was finalized in March 2020, and the 12-month follow-up was finalized in September 2020.Changes to the protocol were introduced after the trial commenced alongside the COVID-19 imposed restrictions at both the practice/provider level and patient level. COVID-19 had an impact on the ability of participating clinic sites to provide ongoing committed PP resources to the study. Many PPs were required to provide other COVID-19-related care services which impacted their ability to perform the duties and activities outlined in the PP role. In Newfoundland & Labrador, we recruited three sites; however only two sites were able to stay engaged throughout the project as one site did not follow the protocol due to staff shortages. Ontario originally had four sites involved; however, one site was unable to identify a PP to do the intervention after the first PP left the clinic and another could not follow protocol due to staff redeployment to COVID-19 activities. For many sites, the 12-month visit occurred 18 months after baseline. As of March 2020, a public health state of emergency was declared in Alberta, Ontario, and Newfoundland & Labrador. During this time all non-essential services were closed, impacting patients’ ability to obtain prevention and screening services. This required a change in protocol from in-person visits with the PP to virtual PP visits to continue with the study. Patient outcomes were also impacted as patients were no longer able to obtain recommended screening (e.g., paps, mammograms, etc.) or attend services to address prevention (e.g., dietary and exercise advice, alcohol cessation, etc.).