Wait a Minute or More: A pragmatic stepped wedge cluster randomised implementation trial assessing a quality improvement program to increase delayed cord clamping for preterm infants.

The intervention comprises a funded, locally adapted quality improvement (QI) program, in addition to basic, accurate data collection and sharing of average number of seconds before cord clamping (NSCC) and rates of delayed cord clamping more than 60 seconds (DCC60 rates) with staff within and across sites. The overall study duration is 92 weeks, divided consecutively into a "Pre-Study Period" of 14 weeks (data collection only), 5 x Study Periods ("Study Period 1", "Study Period 2", etc.) of 14 weeks (data collection and sharing, and stepped QI program), and a "Sustained Implementation Period" of 8 weeks (data collection and sharing only). At the start of each 14-week study period from Study Period 2 onwards, a cluster group of up to 5 hospitals will commence a funded locally adapted QI program in addition to basic data collection and sharing, in a stepped manner. The QI program period will range between 14 weeks (for those allocated to commence in Study Period 5) and 56 weeks (for those allocated to commence in Study Period 2), depending on the randomly allocated step to which that cluster is assigned. The QI program period will cease at the conclusion of Study Period 5 at all sites. The study will continue for a further 8 weeks until the conclusion of the Sustained Implementation Period. The locally adapted QI program period includes local QI team building, QI education (virtual workshop), implementation of locally adapted change ideas, virtual check-in monitoring meetings with a central QI facilitator, data sharing with other clusters also receiving the locally adapted QI program (as opposed to sharing with the central coordinating centre or with all sites, regardless of QI program status) and collaborative learning via quarterly meetings. The QI education will comprise training in "Evidence-based Practice for Improving Quality" (EPIQ). Individual teams will use EPIQ methods to identify causes and drivers preventing delayed cord clamping specific to their site. The intervention is the same for all sites in the study (i.e. all sites will be asked to implement the above components), with the exception of the duration of the program and noting that individual sites will identify change ideas specific to their circumstances. Local QI team formation and implementation of local change ideas is expected within 4 weeks of transition to the QI program step for a given site. Local QI teams are recommended be comprised of 6-8 members, including an obstetrician, a neonatologist/paediatrician, a neonatal nurse, a midwife, a nurse or midwifery educator, a clinical nurse or midwife and a parent. In-keeping with EPIQ methodology, local QI teams will determine the most appropriate means to address their local change ideas. Local QI teams will be supported by a central QI facilitator, who will provide the QI education (virtual workshop) and ongoing support. Local QI teams are recommended to meet with the central facilitators every 4-6 weeks for the duration of their QI program duration (varies between 14 - 56 weeks). Virtual check-in meetings will be held quarterly (i.e. every 3 months) across the study for sites who have commenced their QI program step. Details of local QI team membership, change ideas identified, implementation of individual change ideas, check-in meetings and virtual meeting attendance will be recorded in the study database.