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A Guide to Implementation Science for Phase 3 Clinical Trialists: Designing Trials for Evidence Uptake

Authors:

Harriette G.C. Van Spall, Laura Desveaux, Tracy Finch, Cara C. Lewis, George A. Mensah, Yves Rosenberg, Kavita Singh, Francois Venter, Bryan J. Weiner, Faiez Zannad

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: November 2024

Read the full text in the subscription access Journal of the American College of Cardiology

✪ Balancing realist review outputs with the needs of policymakers and practitioners

Authors:

Ferdinand C Mukumbang, Sonja Klingberg, & Bipin Adhikari

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2024

Read the full text in the open access journal Health Policy and Planning

Abstract:

A realist review is a theory-driven approach to synthesizing evidence based on the realist philosophy of science. Realist reviews are conducted to provide the policy and practice community with a rich, detailed and practical understanding of complex social interventions that will likely be of much more use to them when planning and implementing programmes. Robust realist reviews must balance philosophical engagement, methodological rigour and relevance to practice. Nevertheless, they have been criticized for being more philosophically inclined and less methodologically robust, with findings that have little implication for practice. Using the philosophy/epistemology➔ methodology➔ theory➔ practice concept flow, we report how we balanced philosophical principles and practical insights in a recently conducted realist review on participatory practices that impact the benefits of non-communicable disease research and interventions in low- and middle-income countries. If realist reviews are not comprehensible enough for these practitioners, their utility and relevance may suffer from being limited to a specialist cohort of academics. We propose that realist review findings and outputs must be framed and communicated to meaningfully engage practitioners without undertaking translational efforts.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Community partner coauthorship for increased implementation science impact: Strengthening capacity and engagement

Authors:

Rebekka M. Lee, Cristina Huebner Torres, James G. Daly, Annette Thomas, Peggy A. Hannon, Sonja Likumahuwa-Ackman and Karen M. Emmons

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text open access in the journal Hepatology Communications

Abstract:

Engaging diverse partners in each phase of the research process is the gold standard of community-engaged research and adds value to the impact of implementation science. However, partner engagement in dissemination, particularly meaningful involvement in developing peer-reviewed manuscripts, is lacking. The Implementation Science Centers in Cancer Control are using the Translational Science Benefits Model to demonstrate the impact of our work beyond traditional metrics, including building capacity and promoting community engagement. This paper presents a case example of one center that has developed a policy for including community partners as coauthors. Standard practices are used to foster clear communications and bidirectional collaboration. Of published papers focused on center infrastructure and implementation research pilots, 92% have community partner coauthors. This includes 21 individuals in roles ranging from physician assistant to medical director to quality manager. Through this intentional experience of co-creation, community partners have strengthened implementation science expertise. Community coauthors have also ensured that data interpretation and dissemination reflect real-world practice environments and offer sustainable strategies for rapid translation to practice improvements. Funders, academic journals, and researchers all have important roles to play in supporting community coauthors as critical thought partners who can help to narrow the gap between research and practice.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ The pathway to delivering injectable CAB for HIV prevention: strategies from global PrEP leaders leveraging an adapted version of the Intervention Scalability Assessment Tool (ISAT)

Authors:

Lauren R. Violette, Kidist Zewdie, Nyawira Gitahi, Kristin Beima-Sofie, & Renee Heffron

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Longer-acting cabotegravir (CAB) is a novel, safe, and efficacious pre-exposure prophylaxis (PrEP) for HIV prevention. As we near a time for CAB scale-up, the experience of global leaders in PrEP research and implementation can be leveraged to identify optimal strategies for scaling and integrating CAB into existing PrEP infrastructure worldwide.

Methods

We recruited leaders of HIV prevention clinical trials and large PrEP programs through a combination of purposive and snowball sampling for participation in individual interviews. We conducted interviews using a semi-structured guide that compared CAB to oral PrEP and sought perspectives on barriers and strategies for CAB scale-up. Interviews were conducted virtually, audio recorded, and transcribed. We used thematic analysis, grounded in an adapted version of the Intervention Scalability Assessment Tool (ISAT), to identify critical elements for optimizing delivery of CAB.

Results

From October 2021 to April 2022, we interviewed 30 participants with extensive experience in PrEP research, care, and programming. Participants worked in all seven WHO regions and reported a median of 20 years working in HIV and 10 years in PrEP. Participants agreed that CAB was efficacious and discrete, therefore having the potential to address current concerns about oral PrEP adherence and stigma. Participants indicated direct and indirect costs for provider training, expansion of existing medical infrastructure, and the current medication cost of CAB as major concerns for roll out. The true cost to the end-user and health system were unknown. There were some conflicting strategies on how to best address product targeting, presentation of efficacy, and timing of product availability with scale-up. Some thought that targeting CAB for the general population could normalize PrEP and decrease stigma, while others thought that prioritizing key populations could optimize impact by targeting those with highest risk. Overall, participants emphasized that to ensure successful CAB scale-up, communities and stakeholders must be involved at every stage of planning and implementation.

Conclusions

Our evaluation found that although there is a clear and urgent need for additional HIV PrEP options beyond daily oral PrEP, CAB scale-up must be thoughtful, flexible, and based in lessons learned from oral PrEP rollout.

Contributions to the literature
  • We used the Intervention Scalability Assessment Tool (ISAT), a quantitative tool used to inform decision-making for the scale-up of health interventions, as a framework for a qualitative analysis.
  • To our knowledge, this is the first use of the ISAT to assess scalability of injectable cabotegravir (CAB) for HIV pre-exposure prophylaxis (PrEP).
  • Our findings offer a summary of perspectives from global HIV PrEP leaders, experts, and advocates that can be used to map the process of CAB implementation using existing HIV prevention infrastructure.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ A research agenda to advance the study of implementation mechanisms

Authors:

Cara C. Lewis, Hannah E. Frank, Gracelyn Cruden, Bo Kim, Aubyn C. Stahmer, Aaron R. Lyon, Bianca Albers, Gregory A. Aarons, Rinad S. Beidas, Brian S. Mittman, Bryan J. Weiner, Nate J. Williams, Byron J. Powell & MNoE Group

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Implementation science scholars have made significant progress identifying factors that enable or obstruct the implementation of evidence-based interventions, and testing strategies that may modify those factors. However, little research sheds light on how or why strategies work, in what contexts, and for whom. Studying implementation mechanisms—the processes responsible for change—is crucial for advancing the field of implementation science and enhancing its value in facilitating equitable policy and practice change. The Agency for Healthcare Research and Quality funded a conference series to achieve two aims: (1) develop a research agenda on implementation mechanisms, and (2) actively disseminate the research agenda to research, policy, and practice audiences. This article presents the resulting research agenda, including priorities and actions to encourage its execution.

Method

Building on prior concept mapping work, in a semi-structured, 3-day, in-person working meeting, 23 US-based researchers used a modified nominal group process to generate priorities and actions for addressing challenges to studying implementation mechanisms. During each of the three 120-min sessions, small groups responded to the prompt: “What actions need to be taken to move this research forward?” The groups brainstormed actions, which were then shared with the full group and discussed with the support of facilitators trained in structured group processes. Facilitators grouped critical and novel ideas into themes. Attendees voted on six themes they prioritized to discuss in a fourth, 120-min session, during which small groups operationalized prioritized actions. Subsequently, all ideas were collated, combined, and revised for clarity by a subset of the authorship team.

Results

From this multistep process, 150 actions emerged across 10 priority areas, which together constitute the research agenda. Actions included discrete activities, projects, or products, and ways to shift how research is conducted to strengthen the study of implementation mechanisms.

Conclusions

This research agenda elevates actions to guide the selection, design, and evaluation of implementation mechanisms. By delineating recommended actions to address the challenges of studying implementation mechanisms, this research agenda facilitates expanding the field of implementation science, beyond studying what works to how and why strategies work, in what contexts, for whom, and with which interventions.

Contributions to the literature
  • This research agenda operationalizes a set of activities to strengthen the implementation science field’s focus on why and how strategies work.
  • The research agenda addresses the following activities: accumulating knowledge, innovating methods and overcoming design challenges, improving measurement, providing guidance for specifying causal mechanisms, increasing focus on theorizing, engaging the policy and practice community, engaging funders, building capacity, enhancing equity, and effectively disseminating methods.
  • Studying implementation mechanisms can promote pragmatic strategy development, equitable processes and outcomes, and policy relevance by clarifying pathways for overcoming contextually specific barriers and achieving outcomes of interest.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Use of concept mapping to inform a participatory engagement approach for implementation of evidence-based HPV vaccination strategies in safety-net clinics

Authors:

Jennifer Tsui, Michelle Shin, Kylie Sloan, Thomas I. Mackie, Samantha Garcia, Anne E. Fehrenbacher, Benjamin F. Crabtree & Lawrence A. Palinkas

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Multiple evidence-based strategies (EBS) for promoting HPV vaccination exist. However, adolescent HPV vaccination rates remain below target levels in communities at high risk for HPV-associated cancers and served by safety-net clinics. Participatory engaged approaches are needed to leverage the expertise of community and clinical partners in selecting EBS relevant to their local context. We engaged concept mapping as a method to inform the adoption and adaptation of EBS that seeks to empower implementation partners to prioritize, select, and ultimately implement context-relevant EBS for HPV vaccination.

Methods

Using 38 EBS statements generated from qualitative interviews and national HPV vaccine advocacy sources, we conducted a modified concept mapping activity with partners internal to safety-net clinics and external community members in two study sites of a larger implementation study (Greater Los Angeles and New Jersey), to sort EBS into clusters and rate each EBS by importance and feasibility for increasing HPV vaccination within safety-net clinics. Concept mapping findings (EBS statement ratings, ladder graphs and go-zones) were shared with leaders from a large federally qualified health center (FQHC) system (focusing on three clinic sites), to select and implement EBS over 12 months.

Results

Concept mapping participants (n=23) sorted and rated statements, resulting in an eight-cluster solution: 1) Community education and outreach; 2) Advocacy and policy; 3) Data access/quality improvement monitoring; 4) Provider tracking/audit and feedback; 5) Provider recommendation/communication; 6) Expanding vaccine access; 7) Reducing missed opportunities; and 8) Nurse/staff workflow and training. The FQHC partner then selected to intervene on eight of 17 EBS statements in the “go-zone” for action, with three from “reducing missed opportunities,” two from “nurse/staff workflow and training,” and one each from “provider tracking/audit and feedback,” “provider recommendation/communication,” and “expanding vaccine access,” which the research team addressed through the implementation of three multi-level intervention strategies (e.g., physician communication training, staff training and workflow assessment, audit and feedback of clinic processes).

Conclusions

Concept mapping provided a powerful participatory approach to identify multilevel EBS for HPV vaccination relevant to the local safety-net clinic context, particularly when several strategies exist, and prioritization is necessary. This study demonstrates how a clinic system benefited directly from the ratings and prioritization of EBS by multilevel clinic and community partners within the broader safety-net clinic context to identify and adapt prioritized solutions needed to advance HPV vaccine equity.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ A Community-Partnered Research Process for Implementation Strategy Design: Developing Resources to Support Behavioral Classroom Interventions

Authors:

Gwendolyn M. Lawson, Julie Sarno Owens, David S. Mandell, Samantha Tavlin, Steven Rufe, Aubrey Depa, Aaron R. Lyon, & Thomas J. Power

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

Read the full text in the open access journal School Mental Health

Abstract:

Schools need effective, sustainable implementation strategies to support teachers in using effective Tier 1 (i.e., whole class) and Tier 2 (i.e., targeted) behavioral interventions in the classroom. This paper describes an iterative, community-partnered process of developing implementation resources to support teachers in using Tier 1 and 2 positive behavior management interventions; we call these resources the Positive Behavior Management Toolkit (PBMT). There were two key aspects to the iterative development process: 1) working with a Program Development Team of district—and school-employed partners to identify priorities, interpret data, provide feedback on resources, and plan for sustainment; and 2) conducting a series of tryouts in which teachers used a version of the PBMT in their classrooms and provided quantitative and qualitative feedback on acceptability, appropriateness, feasibility, and recommendations for improvement. In partnership with the Program Development Team, we used data from the tryouts to inform revisions to the PBMT. This paper presents quantitative and qualitative data from the tryouts and describes how these data informed revisions to the PBMT. We also describe the processes by which we engaged the team, considerations related to contextual appropriateness, and lessons learned related to community-engaged intervention development research.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Imagining and implementing healthy city interventions: Combined results from parallel concept mapping exercises in Montreal with community members and stakeholders

Authors:

Zoé Poirier Stephens, Caislin Leah Firth, Michael Cantinotti, Daniel Fuller, Meghan Winters & Yan Kestens

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: May 2024

Read the full text in the subscription access journal Canadian Journal of Public Health

✪ Helping Educational Leaders Mobilize Evidence (HELM): The iterative redesign of the Leadership and Organizational Change for Implementation (LOCI) intervention for use in schools

Authors:

Jill Locke, Cathy M. Corbin, Vaughan K. Collins, Mark G. Ehrhart, Roger Goosey, Kurt Hatch, Christine Espeland, Clayton R. Cook, and Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Few “intervention agnostic” strategies have been developed that can be applied to the broad array of evidence-based practices (EBPs) in schools. This paper describes two studies that reflect the initial iterative redesign phases of an effective leadership-focused implementation strategy—Leadership and Organizational Change for Implementation (LOCI)—to ensure its acceptability, feasibility, contextual appropriateness, and usability when used in elementary schools. Our redesigned strategy—Helping Educational Leaders Mobilize Evidence (HELM)—is designed to improve principals’ use of strategic implementation leadership to support the adoption and high-fidelity delivery of a universal EBP to improve student outcomes.

Method

In Study 1, focus groups were conducted (n = 6) with 54 district administrators, principals, and teachers. Stakeholders provided input on the appropriateness of original LOCI components to maximize relevance and utility in schools. Transcripts were coded using conventional content analysis. Key themes referencing low appropriateness were summarized to inform LOCI adaptations. We then held a National Expert Summit (Study 2) with 15 research and practice experts. Participants provided feedback via a nominal group process (NGP; n = 6 groups) and hackathon (n = 4 groups). The research team rated each NGP suggestion for how actionable, impactful/effective, and feasible it was. We also coded hackathon notes for novel ideas or alignment with LOCI components.

Results

Study 1 suggestions included modifications to LOCI content and delivery. Study 2's NGP results revealed most recommendations to be actionable, impactful/effective, and feasible. Hackathon results surfaced two novel ideas (distributed leadership teams and leaders’ knowledge to support educators EBP use) and several areas of alignment with LOCI components.

Conclusion

Use of these iterative methods informed the redesign of LOCI and the development of HELM. Because it was collaboratively constructed, HELM has the potential to be an effective implementation strategy to support the use of universal EBP in schools.

Plain Language Summary

Our research team designed a strategy (HELM) for school principals to improve the support they provide to staff to implement practices proven to work in research for improving student outcomes. We designed HELM by conducting focus groups with school district administrators, principals, and teachers. Participants were asked for their feedback on how to adapt an existing leadership strategy (LOCI) to the school context. After collecting this feedback, we held a meeting with 15 research and practice experts. During this meeting, the group of experts reviewed the focus group feedback and decided how to incorporate it into the design of the HELM strategy. We believe that collecting this feedback and involving research and practice experts in interpreting and integrating participant feedback into the HELM strategy will make HELM a more effective strategy for supporting school principals’ in implementing supports in their schools.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**