Implementation Strategy Mechanisms Archives - Implementation Science at UW

✪ Study protocol for testing the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in elementary schools: a hybrid type 3 effectiveness-implementation randomized controlled trial

Abstract:

Background

Schools need to implement universal student supports that prevent social, emotional, and behavioral difficulties; minimize associated risks; and promote social, emotional, and behavioral competencies. The purpose of this study is to examine the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy for promoting school-level implementation leadership, implementation climate, and high-fidelity delivery of an evidence-based practice. We will test HELM with an exemplar EBP, Positive Behavioral Interventions and Supports (PBIS). The specific aims of the study are to: 1) experimentally evaluate the effects of HELM versus PBIS training and technical assistance only (control condition); and 2) explore for whom, under what conditions, how equitably, and through which processes HELM works to improve outcomes, as well as its cost-effectiveness.

Methods

This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools. Schools will be randomly assigned to HELM + PBIS training and technical assistance (n = 21 schools; n = 210 educators) or PBIS training and technical assistance only (n = 21 schools; n = 210 educators) in a 1:1 ratio within cohorts using covariate constrained randomization that accounts for degree of prior PBIS exposure (measured using the Tiered Fidelity Inventory at baseline) and school size. A series of mixed effects models (time within educator, educator within school) will test within-subject/between-subject interactions across three timepoints (12 months total) to examine whether HELM will show steeper gains than the control on implementation leadership (primary outcome), implementation climate, PBIS fidelity, and student outcomes. Mediational analyses will test hypothesized mechanisms of change (i.e., implementation leadership and climate) of HELM on PBIS fidelity. Sequential mixed-methods data collection and analyses will further explore how organizational mechanisms are linked to implementation outcomes. Cost-effectiveness analyses will compare costs and outcomes of PBIS training and technical assistance only versus PBIS implementation with HELM.

Discussion

The nature of leadership support in schools can make the difference between successful and unsuccessful EBP implementation. Testing HELM within the context of PBIS implementation will provide rigorous evidence about whether and how HELM can equitably address important EBP and student outcomes.

Trial Registration

Clinical Trials ID: NCT06586723. Date of Registration: August 27, 2024. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06586723?intr=helm&rank=1

Contributions to the Literature

Few effective strategies to enhance evidence-based practice implementation in schools address implementation leadership and climate, and those that do have only been evaluated qualitatively.
Schools have unique organizational characteristics, and it is important to test whether organizational implementation strategies developed in other contexts can be effective in improving implementation outcomes in schools.
This study will evaluate the effects of a tailored adaptation of the Leadership and Organizational Change for Implementation (LOCI) strategy for schools, entitled Helping Educational Leaders Mobilize Evidence (HELM), on implementation mechanisms (implementation leadership and implementation climate), PBIS fidelity, and student outcomes.
This study also will explore for whom, under what conditions, and how equitably HELM demonstrates its effects, providing critical information about influence on – and the limitations of – the impact of this organizational implementation strategy.
Finally, the study will evaluate the processes through which HELM works to improve outcomes, contributing to the emerging literature on implementation mechanisms, as well as its cost-effectiveness.

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Name of the registry
clinicaltrials.gov.

Peer Review reports

✪ Mechanism-Based Middle-Range Theories: Using Realist Syntheses to Reconcile Specificity to Context and Generalizability

Abstract:

Realist synthesis is a recognized methodological approach to evidence synthesis to inform evidence-based health policy and practice. The implicit assumption behind research synthesis is that the evidence it generates should be generalizable––drawing broad inferences from specific observations. While this understanding is generally shared among social scientists, tensions exist between having generalizable evidence and how this evidence can be useful in specific contexts. This paper considers the role of mechanism-based middle-range theories obtained from realist synthesis in bridging specificity to context and generalizability. Retroductive theorizing in realist synthesis helps to identify ideas about mechanisms related to the phenomenon embedded in the social and organizational contexts that could, in principle, have a much broader application. Also, because mechanism-based middle-range theories are linked to contextual features, they capture contextual nuances to enhance evidence implementation. We conclude that middle-range mechanisms provide an opportunity to achieve generalizability and contextualization in implementation science.

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✪ A research agenda to advance the study of implementation mechanisms

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.

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✪ Getting cozy with causality: Advances to the causal pathway diagramming method to enhance implementation precision

Abstract:

Background

Implementation strategies are theorized to work well when carefully matched to implementation determinants and when factors—preconditions, moderators, etc.—that influence strategy effectiveness are prospectively identified and addressed. Existing methods for strategy selection are either imprecise or require significant technical expertise and resources, undermining their utility. This article outlines refinements to causal pathway diagrams (CPDs), a method for articulating the causal process through which implementation strategies work and offers illustrations of their use.

Method

CPDs are a visualization tool to represent an implementation strategy, its mechanism(s) (i.e., the processes through which a strategy is thought to operate), determinants it is intended to address, factors that may impede or facilitate its effectiveness, and the series of outcomes that should be expected if the strategy is operating as intended. We offer principles for constructing CPDs and describe their key functions.

Results

Applications of the CPD method by study teams from two National Institute of Health-funded Implementation Science Centers and a research grant are presented. These include the use of CPDs to (a) match implementation strategies to determinants, (b) understand the conditions under which an implementation strategy works, and (c) develop causal theories of implementation strategies.

Conclusions

CPDs offer a novel method for implementers to select, understand, and improve the effectiveness of implementation strategies. They make explicit theoretical assumptions about strategy operation while supporting practical planning. Early applications have led to method refinements and guidance for the field.

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Embedding school cultures and climates that promote evidence-based practice implementation for youth with autism: A qualitative study

✪ A systematic review of empirical studies examining mechanisms of implementation in health

Abstract:

Background

Understanding the mechanisms of implementation strategies (i.e., the processes by which strategies produce desired effects) is important for research to understand why a strategy did or did not achieve its intended effect, and it is important for practice to ensure strategies are designed and selected to directly target determinants or barriers. This study is a systematic review to characterize how mechanisms are conceptualized and measured, how they are studied and evaluated, and how much evidence exists for specific mechanisms.

Methods

We systematically searched PubMed and CINAHL Plus for implementation studies published between January 1990 and August 2018 that included the terms “mechanism,” “mediator,” or “moderator.” Two authors independently reviewed title and abstracts and then full texts for fit with our inclusion criteria of empirical studies of implementation in health care contexts. Authors extracted data regarding general study information, methods, results, and study design and mechanisms-specific information. Authors used the Mixed Methods Appraisal Tool to assess study quality.

Results

Search strategies produced 2277 articles, of which 183 were included for full text review. From these we included for data extraction 39 articles plus an additional seven articles were hand-entered from only other review of implementation mechanisms (total = 46 included articles). Most included studies employed quantitative methods (73.9%), while 10.9% were qualitative and 15.2% were mixed methods. Nine unique versions of models testing mechanisms emerged. Fifty-three percent of the studies met half or fewer of the quality indicators. The majority of studies (84.8%) only met three or fewer of the seven criteria stipulated for establishing mechanisms.

Conclusions

Researchers have undertaken a multitude of approaches to pursue mechanistic implementation research, but our review revealed substantive conceptual, methodological, and measurement issues that must be addressed in order to advance this critical research agenda. To move the field forward, there is need for greater precision to achieve conceptual clarity, attempts to generate testable hypotheses about how and why variables are related, and use of concrete behavioral indicators of proximal outcomes in the case of quantitative research and more directed inquiry in the case of qualitative research.

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Testing and Exploring the Limits of Traditional Notions of Fidelity and Adaptation in Implementation of Preventive Interventions

✪ From Classification to Causality: Advancing Understanding of Mechanisms of Change in Implementation Science

Abstract:

Background

The science of implementation has offered little toward understanding how different implementation strategies work. To improve outcomes of implementation efforts, the field needs precise, testable theories that describe the causal pathways through which implementation strategies function. In this perspective piece, we describe a four-step approach to developing causal pathway models for implementation strategies.

Building causal models

First, it is important to ensure that implementation strategies are appropriately specified. Some strategies in published compilations are well defined but may not be specified in terms of its core component that can have a reliable and measureable impact. Second, linkages between strategies and mechanisms need to be generated. Existing compilations do not offer mechanisms by which strategies act, or the processes or events through which an implementation strategy operates to affect desired implementation outcomes. Third, it is critical to identify proximal and distal outcomes the strategy is theorized to impact, with the former being direct, measurable products of the strategy and the latter being one of eight implementation outcomes (1). Finally, articulating effect modifiers, like preconditions and moderators, allow for an understanding of where, when, and why strategies have an effect on outcomes of interest.

Future directions

We argue for greater precision in use of terms for factors implicated in implementation processes; development of guidelines for selecting research design and study plans that account for practical constructs and allow for the study of mechanisms; psychometrically strong and pragmatic measures of mechanisms; and more robust curation of evidence for knowledge transfer and use.

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✪ The impact of inter-organizational alignment (IOA) on implementation outcomes: evaluating unique and shared organizational influences in education sector mental health

Abstract:

Background

Integrated healthcare delivered by work groups in nontraditional service settings is increasingly common, yet contemporary implementation frameworks typically assume a single organization—or organizational unit—within which system-level processes influence service quality and implementation success. Recent implementation frameworks predict that inter-organizational alignment (i.e., similarity in values, characteristics, activities related to implementation across organizations) may facilitate the implementation of evidence-based practices (EBP), but few studies have evaluated this premise. This study’s aims examine the impact of overlapping organizational contexts by evaluating the implementation contexts of externally employed mental health clinicians working in schools—the most common integrated service delivery setting for children and adolescents. Aim 1 is to estimate the effects of unique intra-organizational implementation contexts and combined inter-organizational alignment on implementation outcomes. Aim 2 is to examine the underlying mechanisms through which inter-organizational alignment facilitates or hinders EBP implementation.

Methods/design

This study will conduct sequential, exploratory mixed-methods research to evaluate the intra- and inter-organizational implementation contexts of schools and the external community-based organizations that most often employ school-based mental health clinicians, as they relate to mental health EBP implementation. Aim 1 will involve quantitative surveys with school-based, externally-employed mental health clinicians, their supervisors, and proximal school-employed staff (total n = 120 participants) to estimate the effects of each organization’s general and implementation-specific organizational factors (e.g., climate, leadership) on implementation outcomes (fidelity, acceptability, appropriateness) and assess the moderating role of the degree of clinician embeddedness in the school setting. Aim 2 will explore the mechanisms through which inter-organizational alignment influences implementation outcomes by presenting the results of Aim 1 surveys to school-based clinicians (n = 30) and conducting semi-structured qualitative interviews. Qualitative data will be evaluated using an integrative inductive and deductive approach.

Discussion

The study aims are expected to identify intra- and inter-organizational constructs that are most instrumental to EBP implementation success in school-based integrated care settings and illuminate mechanisms that may account for the influence of inter-organizational alignment. In addition to improving school-based mental health, these findings will spur future implementation science that considers the relationships across organizations and optimize the capacity of implementation science to guide practice in increasingly complex systems of care.

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Read the full text in the open access journal Qualitative Health Research

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

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

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Read the full text in the open access journal Frontiers in Public Health

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Building causal models

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Read the full text in the open access journal Implementation Science

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