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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Protocol for a hybrid type 3 cluster randomized trial of a technical assistance system supporting coalitions and
Louis D Brown1, Sarah M Chilenski2, Rebecca Wells3
1School of Public Health in El Paso, The University of Texas Health Science Center at Houston, 5130 Gateway East Blvd., Rm 316, El Paso, TX, 79905, USA. louis.d.brown@uth.tmc.edu.
Background:
Over 5000 community anti-drug coalitions operating in the USA serve as a cornerstone of federal drug prevention. These coalitions, however, have demonstrated effectiveness in preventing substance use only when they use technical assistance (TA) and implement evidence-based programs (EBPs). The absence of TA and EBP implementation by coalitions is a key research-to-practice gap. The Coalition Check-Up TA system is designed to fill this gap by supporting community coalition implementation of EBPs. Existing TA models for evidence-based coalition approaches are resource intensive and coalition model specific. The Coalition Check-Up is a lower cost strategy that works with a variety of types of coalitions to support sustainable implementation of EBPs. This study protocol describes a hybrid type 3 effectiveness-implementation trial applying Wandersman's Interactive Systems Framework to test the effects of the Coalition Check-Up on coalition EBP implementation capacity and outcomes. The Interactive Systems Framework outlines how the prevention support system-especially TA-bolsters EBP dissemination and implementation.
Methods:
Using a cluster randomized controlled design, this trial will test the overall effectiveness of the Coalition Check-Up, including how it contributes to EBP implementation and prevention of youth substance use. The first aim is to estimate the impact of the Coalition Check-Up on coalitions' capacity to do their work. We will recruit 68 anti-drug coalitions for random assignment to the Coalition Check-Up or "TA as usual" condition. We will evaluate whether the Coalition Check-Up improves coalition capacity using measures of coalition member responses about team processes, coalition network composition, and collaborative structure. Our second aim is to estimate the impact of the Coalition Check-Up on implementation of EBPs, and our third aim is to estimate the impact of the Coalition Check-Up on youth substance use.
Discussion:
This project will clarify how the Coalition Check-Up, a scalable approach to TA due to its low cost, affects coalition capacity to support EBP implementation. Analyses also provide insight into causal pathways from the prevention support system to the prevention delivery system outlined by the Interactive Systems Framework. Results will build the evidence-base for how to support community coalitions' sustainable implementation of evidence-based prevention programs and policies.
Trial Registration:
Clinicaltrials.gov registration number NCT04592120 . Registered on October 19, 2020.
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