Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care

Rinad S Beidas, Brian K Ahmedani, Kristin A Linn, Steven C Marcus, Christina Johnson, Melissa Maye, Joslyn Westphal, Leslie Wright, Arne L Beck, Alison M Buttenheim, Matthew F Daley, Molly Davis, Marisa E Elias, Shari Jager-Hyman, Katelin Hoskins, Adina Lieberman, Bridget McArdle, Debra P Ritzwoller, Dylan S Small, Courtney Benjamin Wolk, Nathaniel J Williams, Jennifer M Boggs, Rinad S Beidas, Brian K Ahmedani, Kristin A Linn, Steven C Marcus, Christina Johnson, Melissa Maye, Joslyn Westphal, Leslie Wright, Arne L Beck, Alison M Buttenheim, Matthew F Daley, Molly Davis, Marisa E Elias, Shari Jager-Hyman, Katelin Hoskins, Adina Lieberman, Bridget McArdle, Debra P Ritzwoller, Dylan S Small, Courtney Benjamin Wolk, Nathaniel J Williams, Jennifer M Boggs

Abstract

Background: Insights from behavioral economics, or how individuals' decisions and behaviors are shaped by finite cognitive resources (e.g., time, attention) and mental heuristics, have been underutilized in efforts to increase the use of evidence-based practices in implementation science. Using the example of firearm safety promotion in pediatric primary care, which addresses an evidence-to-practice gap in universal suicide prevention, we aim to determine: is a less costly and more scalable behavioral economic-informed implementation strategy (i.e., "Nudge") powerful enough to change clinician behavior or is a more intensive and expensive facilitation strategy needed to overcome implementation barriers?

Methods: The Adolescent and child Suicide Prevention in Routine clinical Encounters (ASPIRE) hybrid type III effectiveness-implementation trial uses a longitudinal cluster randomized design. We will test the comparative effectiveness of two implementation strategies to support clinicians' use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems. All pediatric practices in the two health systems will receive S.A.F.E. Firearm materials, including training and cable locks. Half of the practices (k = 16) will be randomized to receive Nudge; the other half (k = 16) will be randomized to receive Nudge plus 1 year of facilitation to target additional practice and clinician implementation barriers (Nudge+). The primary implementation outcome is parent-reported clinician fidelity to the S.A.F.E Firearm program. Secondary implementation outcomes include reach and cost. To understand how the implementation strategies work, the primary mechanism to be tested is practice adaptive reserve, a self-report practice-level measure that includes relationship infrastructure, facilitative leadership, sense-making, teamwork, work environment, and culture of learning.

Discussion: The ASPIRE trial will integrate implementation science and behavioral economic approaches to advance our understanding of methods for implementing evidence-based firearm safety promotion practices in pediatric primary care. The study answers a question at the heart of many practice change efforts: which strategies are sufficient to support change, and why? Results of the trial will offer valuable insights into how best to implement evidence-based practices that address sensitive health matters in pediatric primary care.

Trial registration: ClinicalTrials.gov, NCT04844021 . Registered 14 April 2021.

Keywords: Behavioral economics; Evidence-based practice; Firearm safety promotion; Hybrid effectiveness-implementation trials; Implementation science; Pediatrics; Primary care; Violence prevention.

Conflict of interest statement

The authors declare the following competing interests: RSB receives royalties from Oxford University Press. She has served as a consultant to Camden Coalition of Healthcare Providers. She provides consultation to United Behavioral Health. She serves on the Clinical and Scientific Advisory Board for Optum Behavioral Health.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Guiding implementation frameworks. This figure depicts the contextual factors—guided by the Consolidated Framework for Implementation Research (CFIR) [40] (left)—that will be examined in relation to S.A.F.E. Firearm implementation and trial outcomes—guided by the Proctor et al. framework [55] (right)
Fig. 2
Fig. 2
CONSORT diagram
Fig. 3
Fig. 3
S.A.F.E Firearm name and logo based on crowdsourcing. S.A.F.E. Firearm name and logo, which was identified based on feedback from firearm owning and non-firearm owning parents [43]
Fig. 4
Fig. 4
Study timeline. Timeline depicting study phases (pre-trial “pre-implementation” phase, trial “active implementation” phase, and post-trial “sustainment” phase) and study activities

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