Abstract
BackgroundDelivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. The importance of clearly delineating delivery strategies within these complex interventions—and furthermore understanding the impact of each strategy on effectiveness—has recently emerged as an important facet of intervention research. Yet, few methodologies exist to prospectively test the effectiveness of delivery strategies and how they impact implementation. In the current paper, we describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation.Methods/designThe MOST framework contains three distinct phases: Preparation, Optimization, and Evaluation. The Preparation phase for this study occurred previously. The current study consists of the Optimization and Evaluation phases. Children aged 3-to-12 years old who are detected as “at-risk” for behavioral health disorders (n = 304) at a large, urban federally qualified community health center will be referred to a Family Partner—a bicultural, bilingual member of the community with training in behavioral health and systems navigation—who will perform FN. Families will then be randomized to one of 16 possible combinations of FN delivery strategies (2 × 2 × 2× 2 factorial design). The primary outcome measure will be achieving a family-centered goal related to behavioral health services within 90 days of randomization. Implementation data on the fidelity, acceptability, feasibility, and cost of each strategy will also be collected. Results from the primary and secondary outcomes will be reviewed by our team of stakeholders to optimize FN delivery for implementation and dissemination based on effectiveness, efficiency, and cost.DiscussionIn this protocol paper, we describe how the MOST framework can be used to improve intervention delivery. These methods will be useful for future studies testing intervention delivery strategies and their impact on implementation.Trial registrationClinicalTrials.gov, NCT03569449. Registered on 26 June 2018.
Highlights
Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both
Intervention optimization Delivery of behavioral interventions can be complex, as the majority of interventions consist of multiple components that can differ by order, locations, method, or individual
The importance of developing and testing efficient, effective delivery strategies for complex interventions has recently emerged as an important facet of intervention research [1]
Summary
Delivery of behavioral interventions is complex, as the majority of interventions consist of multiple components used either simultaneously, sequentially, or both. We describe a study protocol for a large randomized controlled trial in which we will use the Multiphase Optimization Strategy (MOST), a novel framework developed to optimize interventions, i.e., to test the effectiveness of intervention delivery strategies using a factorial design. We apply this framework to delivery of Family Navigation (FN), an evidence-based care management strategy designed to reduce disparities and improve access to behavioral health services, and test four components related to its implementation. Since its initial publication [4], multiple studies have utilized MOST to develop and test intervention components [5,6,7,8,9,10] with a primary focus on effectiveness [4, 10, 11]
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