Theories and Frameworks 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

✪ Mental health policy implementation in low- and middle-income countries: a realist review protocol

Abstract:

Introduction

Formulating and implementing mental health policy is foundational to public mental health. The implementation of mental health policy varies in low- and middle-income countries (LMICs), with some countries having better implementation outcomes than others. Low implementation poses challenges relating to addressing the high burden and wide treatment gaps of mental health conditions. While different implementation strategies are applied to implement mental health policy in different contexts, there is little knowledge of what category of strategies are being used and how and why their implementation produces varied outcomes. To this end, we propose to conduct a realist synthesis to explain how, why, for whom, and under what health system conditions certain policy implementation strategies work or not in LMICs.

Methods and analysis

This paper will detail the protocol on conducting a realist review of the literature on mental health policy implementation in LMICs. Realist reviews/syntheses are theory-driven reviews designed to formulate and test (confirm, refute, or refine) initial programme theories to explain how, why, for whom and under what contexts a programme, intervention or policy works as intended or not. Theory is built by exploring and abstracting context-mechanism-outcome (CMO) configurations in the data. These CMO configurations are identified through retroductive theorizing, a mechanism-centred approach to theory development. We will adopt these steps to guide the process of realist synthesis: i) identify the research question, clarifying the scope of the review and formulating the initial programme theory (ii) conducting background searches in PubMed, PsycINFO, Africa-Wide Information, African Index Medicus (AIM), CINAHL and Scopus databases, and grey literature (iii) appraising the quality of studies and data extraction and (iv) synthesising data.

Registration

The review is part of a realist evaluation exploring mental health policy implementation in LMICs and is registered under PROSPERO (registration number: CRD42024580312). Findings will inform the development of initial mental health policy implementation programme theories explaining why and how mental health policy implementation in LMICs works.

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✪ Applying health equity implementation science frameworks to population genetic screening

Abstract:

Introduction

Implementation science frameworks with a focus on health equity have emerged to help guide the introduction of new interventions into healthcare and community settings while limiting health disparities. The purpose of this research was to explore the applicability of such frameworks to guide the equitable implementation of population genetic screening programs.

Methods

We searched PubMed and reference lists for relevant frameworks and examples of their use in health settings. We then assessed if and how selected frameworks provide guidance for different stages of population genetic screening: recruitment, sample collection, result return, follow-up care and long-term management, and cascade screening. Findings were synthesized into a list of health equity considerations specific to each stage.

Results

We identified 5 implementation frameworks that focus on health equity. Guidance varied by framework type: determinant (explaining what affects implementation outcomes), process (translating research into practice), or evaluation (assessing implementation). Common characteristics included focusing implementation efforts on populations who have historically experienced health inequities and adapting interventions to fit local contexts. Process models also highlighted the importance of community partnerships.

Discussion

Overall, frameworks offered broad recommendations applicable to population genetic screening program implementation. However, gaps still exist in guidance provided for later stages of population genetic screening. To improve the equitable implementation of genetic screening, future programs may benefit from utilizing one or more of these frameworks or by incorporating the health equity considerations and outcomes compiled in this analysis.

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✪ Navigating grey areas in HIV and mental health implementation science

Abstract:

Introduction

Implementation science (IS) offers methods to systematically achieve the Ending the HIV Epidemic goals in the United States, as well as the global UNAIDS targets. Federal funders such as the National Institutes of Mental Health (NIMH) have invested in implementation research to achieve these goals, including supporting the AIDS Research Centres (ARCs), which focus on high-impact science in HIV and mental health (MH). To facilitate capacity building for the HIV/MH research workforce in IS, “grey areas,” or areas of IS that are confusing, particularly for new investigators, should be addressed in the context of HIV/MH research.

Discussion

A group of IS experts affiliated with NIMH-funded ARCs convened to identify common and challenging grey areas. The group generated a preliminary list of 19 grey areas in HIV/MH-related IS. From the list, the authors developed a survey which was distributed to all ARCs to prioritize grey areas to address in this paper. ARC members across the United States (N = 60) identified priority grey areas requiring clarification. This commentary discusses topics with 40% or more endorsement. The top grey areas that ARC members identified were: (1) Differentiating implementation strategies from interventions; (2) Determining when an intervention has sufficient evidence for adaptation; (3) Integrating recipient perspectives into HIV/MH implementation research; (4) Evaluating whether an implementation strategy is evidence-based; (5) Identifying rigorous approaches for evaluating the impact of implementation strategies in the absence of a control group or randomization; and (6) Addressing innovation in HIV/MH IS grants. The commentary addresses each grey area by drawing from the existing literature (when available), providing expert guidance on addressing each in the context of HIV/MH research, and providing domestic and global HIV and HIV/MH case examples that address these grey areas.

Conclusions

HIV/MH IS is key to achieving domestic and international goals for ending HIV transmission and mitigating its impact. Guidance offered in this paper can help to overcome challenges to rigorous and high-impact HIV/MH implementation research.

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

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.

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✪ Leveraging human-centered design and causal pathway diagramming toward enhanced specification and development of innovative implementation strategies: a case example of an outreach tool to address racial inequities in breast cancer screening

Abstract:

Background

Implementation strategies are strategies to improve uptake of evidence-based practices or interventions and are essential to implementation science. Developing or tailoring implementation strategies may benefit from integrating approaches from other disciplines; yet current guidance on how to effectively incorporate methods from other disciplines to develop and refine innovative implementation strategies is limited. We describe an approach that combines community-engaged methods, human-centered design (HCD) methods, and causal pathway diagramming (CPD)—an implementation science tool to map an implementation strategy as it is intended to work—to develop innovative implementation strategies.

Methods

We use a case example of developing a conversational agent or chatbot to address racial inequities in breast cancer screening via mammography. With an interdisciplinary team including community members and operational leaders, we conducted a rapid evidence review and elicited qualitative data through interviews and focus groups using HCD methods to identify and prioritize key determinants (facilitators and barriers) of the evidence-based intervention (breast cancer screening) and the implementation strategy (chatbot). We developed a CPD using key determinants and proposed strategy mechanisms and proximal outcomes based in conceptual frameworks.

Results

We identified key determinants for breast cancer screening and for the chatbot implementation strategy. Mistrust was a key barrier to both completing breast cancer screening and using the chatbot. We focused design for the initial chatbot interaction to engender trust and developed a CPD to guide chatbot development. We used the persuasive health message framework and conceptual frameworks about trust from marketing and artificial intelligence disciplines. We developed a CPD for the initial interaction with the chatbot with engagement as a mechanism to use and trust as a proximal outcome leading to further engagement with the chatbot.

Conclusions

The use of interdisciplinary methods is core to implementation science. HCD is a particularly synergistic discipline with multiple existing applications of HCD to implementation research. We present an extension of this work and an example of the potential value in an integrated community-engaged approach of HCD and implementation science researchers and methods to combine strengths of both disciplines and develop human-centered implementation strategies rooted in causal perspective and healthcare equity.

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“Another tool in the toolkit”—Perceptions, suggestions, and concerns of emergency service providers about the implementation of a supervised consumption site

Understanding implementation science from the standpoint of health organisation and management: An interdisciplinary exploration of selected theories, models, and frameworks

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✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial Registration

Contributions to the Literature

Authors:

✪ Open Access

Read the full text in the open access journal PLOS One

Abstract:

Introduction

Methods and analysis

Registration

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✪ Open Access

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

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Introduction

Methods

Results

Discussion

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✪ Open Access

Read the full text open access in the Journal of the International AIDS Society

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Introduction

Discussion

Conclusions

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✪ Open Access

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

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Background

Method

Results

Conclusion

Plain Language Summary

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✪ Open Access

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

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Background

Methods

Results

Conclusions

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Subscription Required for Full Text Access

Read the full text in the subscription access journal The International Journal on Drug Policy

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Subscription Required for Full Text Access

Read the full text in the subscription access Journal of Health Organization and Management

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✪ Open Access

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