Background Ghana significantly reduced maternal and newborn mortality between 1990 and 2015, largely through efforts focused on improving access to care. Yet achieving further progress requires improving the quality and timeliness of care. Beginning in 2013, Ghana Health Service and Kybele, a US-based non-governmental organization, developed an innovative obstetric triage system to help midwives assess, diagnosis, and determine appropriate care plans more quickly and accurately. In 2019, efforts began to scale this successful intervention into six additional hospitals. This protocol describes the theory-based implementation approach guiding scale-up and presents the proposed mixed-methods evaluation plan. Methods An implementation theory was developed to describe how complementary implementation strategies would be bundled into a multi-level implementation approach. Drawing on the Interactive Systems Framework and Evidenced Based System for Implementation Support, the proposed implementation approach is designed to help individual facilities develop implementation capacity and also build a learning network across facilities to support the implementation of evidence-based interventions. A convergent design mixed methods approach will be used to evaluate implementation with relevant data drawn from tailored assessments, routinely collected process and quality monitoring data, textual analysis of relevant documents and WhatsApp group messages, and key informant interviews. Implementation outcomes of interest are acceptability, adoption, and sustainability. Discussion The past decade has seen a rapid growth in the development of frameworks, models, and theories of implementation, yet there remains little guidance on how to use these to operationalize implementation practice. This study proposes one method for using implementation theory, paired with other kinds of mid-level and program theory, to guide the replication and evaluation of a clinical intervention in a complex, real-world setting. The results of this study should help to provide evidence of how implementation theory can be used to help close the "know-do" gap. Plain language summary Every woman and every newborn deserves a safe and positive birth experience. Yet in many parts of the world, this goal is often more aspiration than reality. In 2006, Kybele, a US-based non-governmental organization, began working with the Ghanaian government to improve the quality of obstetric and newborn care in a large hospital in Greater Accra. One successful program was the development of a triage system that would help midwives rapidly assess pregnant women to determine who needed what kind of care and develop risk-based care plans. The program was then replicated in another large hospital in the Greater Accra region, where a systematic theory to inform triage implementation was developed. This paper describes the extension of this approach to scale-up the triage program implementation in six additional hospitals. The scale-up is guided by a multi-level theory that extends the facility level theory to include cross-facility learning networks and oversight by the health system. We explain the process of theory development to implement interventions and demonstrate how these require the combination of local contextual knowledge with evidence from the implementation science literature. We also describe our approach for evaluating the theory to assess its effectiveness in achieving key implementation outcomes. This paper provides an example of how to use implementation theories to guide the development and evaluation of complex programs in real-world settings.
