The overall study design is a stepped-wedge cluster randomized trial. A stepped-wedge is
a unidirectional crossover design in which clusters switch treatments at different time
points, enabling statistically rigorous assessment of interventions while reducing
ethical and resource limitations for quality improvement studies.[1] Seven centers will
be randomly assigned to implement the QI bundle at staggered 1-month intervals after a
baseline period. Only the timing of the dissemination visit will be randomized; all sites
will receive the same materials and perform the same activities (e.g. focus group,
process map development, simulations).
This study is an effectiveness-implementation hybrid study. The
effectiveness-implementation hybrid design is ideal for assessing both clinical
interventions and implementation.17 Importantly, our interventions have strong
face-validity, are evidence-based, low-risk and low-cost. For instance, the price to
change BZD formulations is nominal (~$1 per dose), and other QI bundle interventions are
primarily focused on frontline staff process changes. While testing the effect of the QI
bundle on time to BZD treatment, we will utilize this framework and mixed methods
analysis to measure implementation and identify barriers and facilitators. Thus, this
proposal is of high-value, as it will provide randomized multicenter efficacy data while
providing understanding for broad implementation following study end.
For the effectiveness component, we will utilize a stepped-wedge cluster randomized
design. Based on our preliminary data, the intraclass correlation coefficient is
estimated around 0.5, an overall sample size of 60 episodes will be adequate to achieve
powers greater than 90%. A potential pitfall of the stepped wedge design is the potential
confounding effects of temporal trends. We will mitigate this by tracking data at the
primary site, which will be in the sustain phase throughout the study entirety. We reduce
temporal effects of site enrollment (e.g., staffing changes, temporal trends in hospital
admissions) by enrolling sites at different times throughout the calendar year.
The implementation component was designed utilizing the Practical, Robust Implementation
and Sustainability Model (PRISM).[2] PRISM provides a scientifically rigorous and
structured approach to implementation strategy development through domains focusing on
(1) program, (2) external environment, (3) implementation and sustainability
infrastructure and (4) recipients.[2] These elements are addressed as follows:
Program. Organizational readiness across the study sites will be critical for success.
Our proposal is based on evidence derived from a successful single-center study. The QI
bundle is low-cost and all interventions are currently FDA-approved. Our innovative
de-implementation of time-consuming, low-value workflows (e.g. IV medication
administration) will decrease care complexity in the initial stages of SE treatment. The
QI bundle components are trialable, adaptable and reversible. Treatment results are
immediately observable by stakeholders through individual outcomes (SE cessation) and
shared measure and feedback data reports. We highlight improved outcomes and safety as
organizational, caregiver, and patient priorities to achieve broad buy-in.
External Environment. Regulatory and professional organization priorities support our
area of study and primary efficacy outcomes. Rapid treatment of SE has been identified as
a quality measure by the AAN11, and guidelines for such care have been published by the
AES.[3] Additionally, our study proposal further aligns with NAEC, which mandates a focus
on rapid treatment of SE through pathway requirements across 260 hospitals. Data from our
proposal will serve as a framework for accomplishing the goal of rapid SE treatment,
which is inconsistently met at present.[4]
Implementation and sustainability infrastructure. Our infrastructure will utilize proven
features associated with successful implementation projects.[5,6] Co-investigators
experienced in working within pSERG will provide a bridge to the local QI and clinical
teams, engaging stakeholders at all 3 organizational levels (frontline staff, mid-level
management and senior administration). Measure and feedback will be emphasized through
control chart data and implementation reports. Furthermore, the adaptable protocol allows
for site-specific implementation strategies for the QI bundle as well as iterative PDSA
development in the Sustain and Independent phases in order to address local drivers.
Recipients. Positive organizational characteristics are supported by LOS from senior
hospital administrators and nurse managers. Furthermore, the co-investigators have
previously collaborated with pSERG from their respective centers. Each site has access to
data through Export, Transform, Load (ETL) data queries and EHR. The diverse demographics
of patients is aided through intentional site selection and inclusion of nearly all ages
of children. Importantly, our proposed interventions of performing basic seizure first
aid and using non-IV forms of BZD aligns with those of patients and families in the
ambulatory setting.[7]