Christopher Fittipaldi Akiba

Background: More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone’s ability to improve naloxone distribution in general and among BIPOC specifically. Methods: We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone’s ability to improve SSPs’ naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness. Discussion: This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.

Background: Fidelity measurement of implementation strategies is underdeveloped and underreported, and the level of reporting is decreasing over time. Failing to properly measure the factors that affect the delivery of an implementation strategy may obscure the link between a strategy and its outcomes. Barriers to assessing and reporting implementation strategy fidelity among researchers are not well understood. The aims of this qualitative study were to identify barriers to fidelity measurement and pragmatic pathways towards improvement. Methods: We conducted in-depth interviews among researchers conducting implementation trials. We utilized a theory-informed interview approach to elicit the barriers and possible solutions to implementation strategy fidelity assessment and reporting. Reflexive-thematic analysis guided coding and memo-writing to determine key themes regarding barriers and solutions. Results: Twenty-two implementation researchers were interviewed. Participants agreed that implementation strategy fidelity was an essential element of implementation trials and that its assessment and reporting should improve. Key thematic barriers focused on (1) a current lack of validated fidelity tools with the need to assess fidelity in the short term, (2) the complex nature of some implementation strategies, (3) conceptual complications when assessing fidelity within mechanisms-focused implementation research, and (4) structural issues related to funding and publishing. Researchers also suggested pragmatic solutions to overcome each barrier. Respondents reported using specification and tracking data in the short term until validated tools become available. Participants suggested that researchers with strategy-specific content expertise lead the way in identifying core components and setting fidelity requirements for them. Addressing the third barrier, participants provided examples of what pragmatic prospective and retrospective fidelity assessments might look like along a mechanistic pathway. Finally, researchers described approaches to minimize costs of data collection, as well as more structural accountability like adopting and enforcing reporting guidelines or changing the structure of funding opportunities. Discussion: We propose short- and long-term priorities for improving the assessment and reporting of implementation strategy fidelity and the quality of implementation research. Conclusions: A better understanding of the barriers to implementation strategy fidelity assessment may pave the way towards pragmatic solutions.

Background: Fidelity measurement of implementation strategies is underdeveloped and underreported, and the level of reporting is decreasing over time. Failing to properly measure the factors that affect the delivery of an implementation strategy may obscure the link between a strategy and its outcomes. Barriers to assessing and reporting implementation strategy fidelity among researchers are not well understood. The aims of this qualitative study were to identify barriers to fidelity measurement and pragmatic pathways towards improvement. Methods: We conducted in-depth interviews among researchers conducting implementation trials. We utilized a theory-informed interview approach to elicit the barriers and possible solutions to implementation strategy fidelity assessment and reporting. Reflexive-thematic analysis guided coding and memo-writing to determine key themes regarding barriers and solutions. Results: Twenty-two implementation researchers were interviewed. Participants agreed that implementation strategy fidelity was an essential element of implementation trials and that its assessment and reporting should improve. Key thematic barriers focused on (1) a current lack of validated fidelity tools with the need to assess fidelity in the short term, (2) the complex nature of some implementation strategies, (3) conceptual complications when assessing fidelity within mechanisms-focused implementation research, and (4) structural issues related to funding and publishing. Researchers also suggested pragmatic solutions to overcome each barrier. Respondents reported using specification and tracking data in the short term until validated tools become available. Participants suggested that researchers with strategy-specific content expertise lead the way in identifying core components and setting fidelity requirements for them. Addressing the third barrier, participants provided examples of what pragmatic prospective and retrospective fidelity assessments might look like along a mechanistic pathway. Finally, researchers described approaches to minimize costs of data collection, as well as more structural accountability like adopting and enforcing reporting guidelines or changing the structure of funding opportunities. Discussion: We propose short- and long-term priorities for improving the assessment and reporting of implementation strategy fidelity and the quality of implementation research. Conclusions: A better understanding of the barriers to implementation strategy fidelity assessment may pave the way toward pragmatic solutions.

Implementation strategies are systematic approaches to improve the uptake and sustainability of evidence-based interventions. They frequently focus on changing provider behavior through the provision of interventions such as training, coaching, and audit-and-feedback. Implementation strategies often impact intermediate behavioral outcomes like provider guideline adherence, in turn improving patient outcomes. Fidelity of implementation strategy delivery is defined as the extent to which an implementation strategy is carried out as it was designed. Implementation strategy fidelity measurement is under-developed and under-reported, with the quality of reporting decreasing over time. Benefits of fidelity measurement include the exploration of the extent to which observed effects are moderated by fidelity, and critical information about Type-III research errors, or the likelihood that null findings result from implementation strategy fidelity failure. Reviews of implementation strategy efficacy often report wide variation across studies, commonly calling for increased implementation strategy fidelity measurement to help explain variations. Despite the methodological benefits of rigorous fidelity measurement, implementation researchers face multi-level challenges and complexities. Challenges include the measurement of a complex variable, multiple data collection modalities with varying precision and costs, and the need for fidelity measurement to change in-step with adaptations. In this position paper, we weigh these costs and benefits and ultimately contend that implementation strategy fidelity measurement and reporting should be improved in trials of implementation strategies. We offer pragmatic solutions for researchers to make immediate improvements like the use of mixed methods or innovative data collection and analysis techniques, the inclusion of implementation strategy fidelity assessment in reporting guidelines, and the staged development of fidelity tools across the evolution of an implementation strategy. We also call for additional research into the barriers and facilitators of implementation strategy fidelity measurement to further clarify the best path forward.