Lessons Learned in Virtual Launch of an Antenatal Opioid Exposure Study During the COVID-19 Pandemic.

Abstract

Background: The COVID-19 pandemic prompted researchers to develop new ways to design and launch studies and recruit and retain participants. Pregnant women and infants are considered vulnerable populations in research, and families affected by substance use are particularly difficult to recruit and retain. Recruitment for studies involving medical technologies such as MRI can also be difficult due to misconceptions and fear of the technologies.

Objectives: To describe "lessons learned" during the launch of the Outcomes of Babies with Opioid Exposure (OBOE) study, including successes and challenges when working with high-risk infants and families and the importance of engaging participants through recruitment materials and retention efforts.

Methods: The OBOE study is a multisite prospective longitudinal cohort study comparing infants with antenatal opioid exposure to unexposed controls from birth to 2 years of age. Chi-square tests were used to examine refusal reasons among caregivers of eligible infants by exposure group and differences in 6-month retention among subgroups based on social determinants of health.

Results: Four factors were essential in establishing the Consortium, implementing the study, and retaining participants: (a) creating venues for collaboration, (b) pivoting from in-person to virtual training, (c) anticipating potential enrollment barriers and addressing them directly, and (d) engaging participants through recruitment materials and retention efforts. With these factors in place, only 5% of caregivers of eligible opioid-exposed infants and 8% of control infants declined to participate in the study because of MRIs. Of 310 enrolled infants, 234 infants had attended the 6-month visit. Subgroups of enrolled infants were similar in retention at 6 months.

Discussion: Reporting our successes and challenges in setting up a nationwide consortium during the pandemic may help other consortia that need to be set up virtually. We anticipated that the serial MRIs would be a barrier to participation; however, few indicated they refused to participate because of MRIs, suggesting our efforts to address this potential barrier to enrollment were successful.