Funding: NHLBI
Investigator(s): Bonafide, C
The EMO effectiveness deimplementation trial, funded by the National Heart, Lung, and Blood Institute is a four-phase project seeking to eliminate monitor over use in children with bronchiolitis and to identify a de-implementation strategy. Bronchiolitis is the leading cause of infant hospitalization. There are over 100,000 admissions and 1.7 billion dollars in hospital charges. Pulse oximetry is a common intervention but does not improve outcomes for patients during hospitalization when supplemental oxygen is being administered. This study discourages the continuous use of monitoring SPO2 for children who are in room air which will maximize quality and minimize waste in our health care.
EMO is designed as a multicenter hybrid type III effectiveness-deimplementation trial with a longitudinal cluster-randomized design. The trial will be conducted on PRIS Network hospital inpatient units that care for children with bronchiolitis, excluding ICUs, emergency departments, and step-down units. Subject populations include bronchiolitis patients, parents or guardians of bronchiolitis patients who participate in qualitative interviews, and hospital staff who care for bronchiolitis patients and participate in questionnaires and interviews. The trial includes 3 main phases (baseline, active deimplementation, and sustainability) and an exploratory fourth phase.
The Data and Safety Monitoring Board will oversee the clinical trial. The Clinical Research Collaboration Unit (CRCU) at the University of Pennsylvania serves as the DCC and provides project management, data management, and research technology support. All research data for this trial will be stored in an electronic database that is managed by the Research Technologies Department (RTD) of the CRCU.
The study recruitment started January 2022 and has completed its first 3 phases. The exploratory (4th) phase is scheduled to begin on December 1, 2024.