Direct-to-participant recruitment of mothers and infants: A strategic approach during challenging pandemic times.

Under traditional circumstances, most clinical trials rely on in-person operations to identify, recruit, and enroll study participants and to complete study-related visits. During unusual circumstances, such as the COVID-19 pandemic, the typical clinical trial model is challenged and forced to explore alternative approaches to implementing study recruitment, participant enrollment, and data collection strategies. One such alternative is a direct-to-participant approach which leverages electronic resources and relevant technological devices (e.g., smart phones) available to researchers and patients. This approach functions under the assumption that a participant has access to a device that connects to the internet such as a smart phone, tablet, or computer. Researchers are then able to transition a typical paper-based, in-person model to an electronic-based, siteless, remote study. This article describes the challenges clinicians and researchers faced when implementing a direct-to-participant study approach during the COVID-19 pandemic. The lessons learned during this study of infant populations could help increase efficiency of future trials, specifically, by lessening the burden on participants and clinicians as well as streamlining the process for enrollment and data collection. While direct-to-adult participant recruitment is not a novel approach, our findings suggest that studies attempting to recruit the infant population may benefit from such a direct-to-participant approach.

Enhancing residents' neonatal resuscitation competency through unannounced simulation-based training.

BACKGROUND: Almost half of pediatric third-year residents surveyed in 2000 had never led a resuscitation event. With increasing restrictions on residency work hours and a decline in patient volume in some hospitals, there is potential for fewer opportunities. PURPOSE: Our primary purpose was to test the hypothesis that an unannounced mock resuscitation in a high-fidelity in-situ simulation training program would improve both residents' self-confidence and observed performance of adopted best practices in neonatal resuscitation. METHODS: Each pediatric and medicine-pediatric resident in one pediatric residency program responded to an unannounced scenario that required resuscitation of the high fidelity infant simulator. Structured debriefing followed in the same setting, and a second cycle of scenario response and debriefing occurred before ending the 1-hour training experience. Measures included pre- and post-program confidence questionnaires and trained observer assessments of live and videotaped performances. RESULTS: Statistically significant pre-post gains for self-confidence were observed for 8 of the 14 NRP critical behaviors (p=0.00-0.03) reflecting knowledge, technical, and non-technical (teamwork) skills. The pre-post gain in overall confidence score was statistically significant (p=0.00). With a maximum possible assessment score of 41, the average pre-post gain was 8.28 and statistically significant (p<0.001). Results of the video-based assessments revealed statistically significant performance gains (p<0.0001). Correlation between live and video-based assessments were strong for pre-post training scenario performances (pre: r=0.64, p<0.0001; post: r=0.75, p<0.0001). CONCLUSIONS: Results revealed high receptivity to in-situ, simulation-based training and significant positive gains in confidence and observed competency-related abilities. Results support the potential for other applications in residency and continuing education.