Development, implementation, and evaluation of a novel guideline engine for pediatric patients with severe traumatic brain injury: a study protocol.

Background: Severe traumatic brain injury (TBI) is a leading cause of death and disability for children. The Brain Trauma Foundation released evidence-based guidelines, a series of recommendations regarding care for pediatric patients with severe TBI. Clinical evidence suggests that adoption of guideline-based care improves outcomes in patients with severe TBI. However, guideline implementation has not been systematic or consistent in clinical practice. There is also a lack of information about implementation strategies that are effective given the nature of severe TBI care and the complex environment in the intensive care unit (ICU). Novel technology-based strategies may be uniquely suited to the fast-paced, transdisciplinary care delivered in the ICU, but such strategies must be carefully developed and evaluated to prevent unintended consequences within the system of care. This challenge presents a unique opportunity for intervention to more appropriately implement guideline-based care for pediatric patients with severe TBI.

Methods: This mixed-method study will develop a novel technology-based bedside guideline engine (the implementation strategy) to facilitate uptake of evidence-based guidelines (the intervention) for management of severe TBI. Group model building and systems dynamics will inform the guideline engine design, and bedside functionality will be initially assessed through patient simulation. Using the Promoting Action on Research Implementation in Health Services (PARIHS) framework, we will determine the feasibility of incorporating the guideline engine in the ICU. Study participants will include pediatric patients with severe TBI and providers at three trauma centers. Quantitative data will include measures of guideline engine acceptance and organizational readiness for change. Qualitative data will include semi-structured interviews from clinicians. We will test the feasibility of incorporating the guideline engine in "real life practice" in preparation for a future clinical trial that will assess clinical and implementation outcomes, including feasibility, acceptability, and adoption of the guideline engine.

Discussion: This study will lead to the development and feasibility testing of an adaptable strategy for implementing guideline-based care for severe TBI, a strategy that meets the needs of individual critical care environments and patients. A future study will test the adaptability and impact of the bedside guideline engine in a randomized clinical trial.