Testing the leadership and organizational change for implementation (LOCI) intervention in Norwegian mental health clinics: a stepped-wedge cluster randomized design study protocol

BACKGROUND: Alignment across levels of leadership within an organization is needed for successful implementation of evidence-based practice. The leadership and organizational change for implementation (LOCI) intervention is a multi-faceted multilevel implementation strategy focusing on enhancing first-level general and implementation leadership while also engaging with organization upper management to develop an organizational climate for implementation. The aim of the project is to evaluate the effectiveness of LOCI in supporting the implementation of evidence-based treatment for PTSD in child- and adult-specialized mental health clinics in health trusts in Norway. METHODS: The study design is a stepped-wedge cluster randomized trial with enrollment of clinics in three cohorts. Executives, clinic leaders, and therapists will be asked to complete surveys assessing leadership and implementation climate. Surveys will be completed at baseline, 4, 8, 12, 16, and 20 months. Results from surveys will be shared with executives and clinic leaders to inform the subsequent creation of tailored leadership and climate development plans for enhanced implementation. Patients will complete surveys measuring traumatic events and post-traumatic stress symptoms during the therapy process. Therapy sessions will be audio or video recorded and scored for fidelity as part of training. DISCUSSION: This study aims to provide knowledge on how to improve leadership and organizational climate to enhance effective implementation of evidence-based treatments in mental health services. TRIAL REGISTRATION: The study has been registrated in ClinicalTrials with ID NCT03719651.