Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial

Background: Our research consortium is preparing for a prospective multicenter trial evaluating the impact of teleneonatology on the health outcomes of at-risk neonates born in community hospitals. We completed a 6-month pilot study to determine the feasibility of the trial protocol. Methods: Four neonatal intensive care units (“hubs”) and four community hospitals (“spokes”) participated in the pilot—forming four hub-spoke dyads. Two hub-spoke dyads implemented synchronous, audio-video telemedicine consultations with a neonatologist (“teleneonatology”). The primary outcome was a composite feasibility score that included one point for each of the following: site retention, on-time screening log completion, no eligibility errors, on-time data submission, and sponsor site-dyad meeting attendance (score range 0–5). Results: For the 20 hub-spoke dyad months, the mean (range) composite feasibility score was 4.6 (4, 5). All sites were retained during the pilot. Ninety percent (18/20) of screening logs were completed on time. The eligibility error rate was 0.2% (3/1809). On-time data submission rate was 88.4% (84/95 case report forms). Eighty-five percent (17/20) of sponsor site-dyad meetings were attended by both hub and spoke site staff. Conclusions: A multicenter teleneonatology clinical effectiveness trial is feasible. Learnings from the pilot study may improve the likelihood of success of the main trial. Impact: A prospective, multicenter clinical trial evaluating the impact of teleneonatology on the early health outcomes of at-risk neonates born in community hospitals is feasible.A multidimensional composite feasibility score, which includes processes and procedures fundamental to completing a clinical trial, is useful for quantitatively measuring pilot study success.A pilot study allows the investigative team to test trial methods and materials to identify what works well or requires modification. Learnings from a pilot study may improve the quality and efficiency of the main effectiveness trial.