Randomized trial of the leadership and organizational change for implementation (LOCI) strategy in substance use treatment clinics.

Introduction: Evidence-based practice (EBP) implementation represents a strategic change that requires alignment of leadership and support throughout organizations. Leadership and Organizational Change for Implementation (LOCI) is a multifaceted implementation strategy that aims to improve implementation leadership and climate within organizations through iterative cycles of leadership and climate assessment and feedback, leadership training and coaching, and strategic planning with upper-level leaders. This study tested the effects of LOCI on transformational and implementation leadership, implementation climate, implementation citizenship behavior, and EBP reach.

Methods: A multiple cohort, cluster randomized trial tests the effect of LOCI in 60 clinics across nine behavioral health organizations in California and Arizona, USA. The study randomized clinics within organizations to either LOCI or a leadership training webinar control condition in three consecutive cohorts. Repeated web-based surveys of direct service providers (n = 201, n = 179) assessed leadership, implementation climate, and implementation citizenship over time. Multilevel autoregressive modeling was the primary statistical analysis such that providers (level-1) were nested within clinics (level-2). The study predicted between-condition differences at 4-, 8-, and 12-month follow-up assessments. Provider engagement in a fidelity monitoring process assessed reach of motivational interviewing (i.e., number of sessions recorded/submitted for fidelity coding). An independent sample t-test explored between condition differences in motivational interviewing reach.

Results: Results indicated between condition differences at 4 months for implementation leadership, implementation climate, and implementation citizenship behavior such that greater improvements were evidenced in the LOCI condition compared to the control condition. Reach of MI was significantly greater in the LOCI vs control condition such that LOCI providers were significantly more likely to engage in the fidelity monitoring process (chi-square (1, n = 370) = 5.59, p = .018).

Conclusions: LOCI was developed based on organizational theories of strategic leadership and climate to affect organizational change processes that communicate that innovation implementation is expected, supported, and recognized as a value of the organization. The LOCI implementation strategy resulted in more positive hypothesized outcomes compared to the control condition. Organizational change strategies have utility for implementing health innovations in complex, multilevel contexts and for greater sustainment of facilitative leader behaviors, strategic implementation climate, and improved implementation outcomes.

Trial Registration: This study is registered with Clinicaltrials.gov gov (NCT03042832, 2 February 2017; retrospectively registered).