Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: Protocol for a Cluster Randomized Controlled Trial

BACKGROUND: Family-centered rounds is recognized as a best practice for hospitalized children, but it has only been possible for children whose families can physically be at the bedside during hospital rounds. The use of telehealth to bring a family member virtually to the child’s bedside during rounds is a promising solution. We aim to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes. METHODS: This two-arm cluster randomized controlled trial will randomize families of hospitalized infants to have the option to use telehealth for virtual rounds (intervention) or usual care (control). The intervention-arm families will also have the option to participate in rounds in-person or to not participate in rounds. All eligible infants who are admitted to this single-site neonatal intensive care unit during the study period will be included. Eligibility requires that there be an English-proficient adult parent or guardian. We will measure participant-level outcome data to test the impact on family-centered rounds attendance, parent experience, family-centered care, parent activation, parent health-related quality of life, length of stay, breastmilk feeding, and neonatal growth. Additionally, we will conduct a mixed methods implementation evaluation using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. DISCUSSION: The findings from this trial will increase our understanding about virtual family-centered rounds in the neonatal intensive care unit. The mixed methods implementation evaluation will enhance our understanding about the contextual factors that influence the implementation and rigorous evaluation of our intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05762835. Status: Not yet recruiting. First Posted: 3/10/2023; Last Update Posted: 3/10/2023.