Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention The CORE Study

Background:Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs) has until recently however, been fairly limited.Method/Design:A nested process evaluation (NPE) was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users). Process evaluation data collection combines qualitative and quantitative methods with four aims: (1) to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2) to understand how the codesign intervention works, the cluster variability in implementation, and if the interventio...