Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial.

BackgroundThe Diabetes Prevention Program (DPP) study showed that lifestyle intervention resulted in a 58% reduction in incidence of type 2 diabetes among individuals with prediabetes. Additional large randomized controlled trials have confirmed these results, and long-term follow-up has shown sustained benefit 10-20 years after the interventions ended. Diabetes is a common and costly disease, especially among Veterans, and despite strong evidence supporting the feasibility of type 2 diabetes prevention, the DPP has not been widely implemented. The first aim of this study will evaluate implementation of the Veterans Affairs (VA) DPP in three VA medical centers. The second aim will assess weight and hemoglobin A1c (A1c) outcomes, and the third aim will determine the cost-effectiveness and budget impact of implementation of the VA DPP from a health system perspective.Methods/designThis partnered multi-site non-randomized systematic assignment study will use a highly pragmatic hybrid effectiveness-implementation type III mixed methods study design. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Seven hundred twenty eligible Veterans will be systematically assigned to the VA DPP clinical demonstration or the usual care VA MOVE!® weight management program. A multi-phase formative evaluation of the VA DPP implementation will be conducted. A theoretical program change model will be used to guide the implementation process and assess applicability and feasibility of the DPP for VA. The Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection, analysis, and interpretation of barriers and facilitators to implementation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of the VA DPP. Twelve-month weight and A1c change will be evaluated for the VA DPP compared to the VA MOVE!ProgramMediation analyses will be conducted to identify whether program design differences impact outcomes.DiscussionFindings from this pragmatic evaluation will be highly applicable to practitioners who are tasked with implementing the DPP in clinical settings. In addition, findings will determine the effectiveness and cost-effectiveness of the VA DPP in the Veteran population

Inside help: An integrative review of champions in healthcare-related implementation

Background/aims: The idea that champions are crucial to effective healthcare-related implementation has gained broad acceptance; yet the champion construct has been hampered by inconsistent use across the published literature. This integrative review sought to establish the current state of the literature on champions in healthcare settings and bring greater clarity to this important construct. Methods: This integrative review was limited to research articles in peer-reviewed, English-language journals published from 1980 to 2016. Searches were conducted on the online MEDLINE database via OVID and PubMed using the keyword "champion." Several additional terms often describe champions and were also included as keywords: implementation leader, opinion leader, facilitator, and change agent. Bibliographies of full-text articles that met inclusion criteria were reviewed for additional references not yet identified via the main strategy of conducting keyword searches in MEDLINE. A five-member team abstracted all full-text articles meeting inclusion criteria. Results: The final dataset for the integrative review consisted of 199 unique articles. Use of the term champion varied widely across the articles with respect to topic, specific job positions, or broader organizational roles. The most common method for operationalizing champion for purposes of analysis was the use of a dichotomous variable designating champion presence or absence. Four studies randomly allocated of the presence or absence of champions. Conclusions: The number of published champion-related articles has markedly increased: more articles were published during the last two years of this review (i.e. 2015-2016) than during its first 30 years (i.e. 1980-2009).The number of champion-related articles has continued to increase sharply since the year 2000. Individual studies consistently found that champions were important positive influences on implementation effectiveness. Although few in number, the randomized trials of champions that have been conducted demonstrate the feasibility of using experimental design to study the effects of champions in healthcare

Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: Results from the Expert Recommendations for Implementing Change (ERIC) study

BackgroundPoor terminological consistency for core concepts in implementation science has been widely noted as an obstacle to effective meta-analyses. This inconsistency is also a barrier for those seeking guidance from the research literature when developing and planning implementation initiatives. The Expert Recommendations for Implementing Change (ERIC) study aims to address one area of terminological inconsistency: discrete implementation strategies involving one process or action used to support a practice change. The present report is on the second stage of the ERIC project that focuses on providing initial validation of the compilation of 73 implementation strategies that were identified in the first phase.FindingsPurposive sampling was used to recruit a panel of experts in implementation science and clinical practice (N = 35). These key stakeholders used concept mapping sorting and rating activities to place the 73 implementation strategies into similar groups and to rate each strategy’s relative importance and feasibility. Multidimensional scaling analysis provided a quantitative representation of the relationships among the strategies, all but one of which were found to be conceptually distinct from the others. Hierarchical cluster analysis supported organizing the 73 strategies into 9 categories. The ratings data reflect those strategies identified as the most important and feasible.ConclusionsThis study provides initial validation of the implementation strategies within the ERIC compilation as being conceptually distinct. The categorization and strategy ratings of importance and feasibility may facilitate the search for, and selection of, strategies that are best suited for implementation efforts in a particular setting.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-015-0295-0) contains supplementary material, which is available to authorized users

Expert recommendations for implementing change (ERIC): Protocol for a mixed methods study

BACKGROUND: Identifying feasible and effective implementation strategies that are contextually appropriate is a challenge for researchers and implementers, exacerbated by the lack of conceptual clarity surrounding terms and definitions for implementation strategies, as well as a literature that provides imperfect guidance regarding how one might select strategies for a given healthcare quality improvement effort. In this study, we will engage an Expert Panel comprising implementation scientists and mental health clinical managers to: establish consensus on a common nomenclature for implementation strategy terms, definitions and categories; and develop recommendations to enhance the match between implementation strategies selected to facilitate the use of evidence-based programs and the context of certain service settings, in this case the U.S. Department of Veterans Affairs (VA) mental health services. METHODS/DESIGN: This study will use purposive sampling to recruit an Expert Panel comprising implementation science experts and VA mental health clinical managers. A novel, four-stage sequential mixed methods design will be employed. During Stage 1, the Expert Panel will participate in a modified Delphi process in which a published taxonomy of implementation strategies will be used to establish consensus on terms and definitions for implementation strategies. In Stage 2, the panelists will complete a concept mapping task, which will yield conceptually distinct categories of implementation strategies as well as ratings of the feasibility and effectiveness of each strategy. Utilizing the common nomenclature developed in Stages 1 and 2, panelists will complete an innovative menu-based choice task in Stage 3 that involves matching implementation strategies to hypothetical implementation scenarios with varying contexts. This allows for quantitative characterizations of the relative necessity of each implementation strategy for a given scenario. In Stage 4, a live web-based facilitated expert recommendation process will be employed to establish expert recommendations about which implementations strategies are essential for each phase of implementation in each scenario. DISCUSSION: Using a novel method of selecting implementation strategies for use within specific contexts, this study contributes to our understanding of implementation science and practice by sharpening conceptual distinctions among a comprehensive collection of implementation strategies

Coincidence analysis: a new method for causal inference in implementation science

Background Implementation of multifaceted interventions typically involves many diverse elements working together in interrelated ways, including intervention components, implementation strategies, and features of local context. Given this real-world complexity, implementation researchers may be interested in a new mathematical, cross-case method called Coincidence Analysis (CNA) that has been designed explicitly to support causal inference, answer research questions about combinations of conditions that are minimally necessary or sufficient for an outcome, and identify the possible presence of multiple causal paths to an outcome. CNA can be applied as a standalone method or in conjunction with other approaches and can reveal new empirical findings related to implementation that might otherwise have gone undetected. Methods We applied CNA to a publicly available dataset from Sweden with county-level data on human papillomavirus (HPV) vaccination campaigns and vaccination uptake in 2012 and 2014 and then compared CNA results to the published regression findings. Results The original regression analysis found vaccination uptake was positively associated only with the availability of vaccines in schools. CNA produced different findings and uncovered an additional solution path: high vaccination rates were achieved by either (1) offering the vaccine in all schools or (2) a combination of offering the vaccine in some schools and media coverage. Conclusions CNA offers a new comparative approach for researchers seeking to understand how implementation conditions work together and link to outcomes.publishedVersio

Toward criteria for pragmatic measurement in implementation research and practice: a stakeholder-driven approach using concept mapping

Background: Advancing implementation research and practice requires valid and reliable measures of implementation determinants, mechanisms, processes, strategies, and outcomes. However, researchers and implementation stakeholders are unlikely to use measures if they are not also pragmatic. The purpose of this study was to establish a stakeholder-driven conceptualization of the domains that comprise the pragmatic measure construct. It built upon a systematic review of the literature and semi-structured stakeholder interviews that generated 47 criteria for pragmatic measures, and aimed to further refine that set of criteria by identifying conceptually distinct categories of the pragmatic measure construct and providing quantitative ratings of the criteria’s clarity and importance. Methods: Twenty-four stakeholders with expertise in implementation practice completed a concept mapping activity wherein they organized the initial list of 47 criteria into conceptually distinct categories and rated their clarity and importance. Multidimensional scaling, hierarchical cluster analysis, and descriptive statistics were used to analyze the data. Findings: The 47 criteria were meaningfully grouped into four distinct categories: (1) acceptable, (2) compatible, (3) easy, and (4) useful. Average ratings of clarity and importance at the category and individual criteria level will be presented. Conclusions: This study advances the field of implementation science and practice by providing clear and conceptually distinct domains of the pragmatic measure construct. Next steps will include a Delphi process to develop consensus on the most important criteria and the development of quantifiable pragmatic rating criteria that can be used to assess measures

A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework

<p>Abstract</p> <p>Background</p> <p>The Promoting Action on Research Implementation in Health Services framework, or PARIHS, is a conceptual framework that posits key, interacting elements that influence successful implementation of evidence-based practices. It has been widely cited and used as the basis for empirical work; however, there has not yet been a literature review to examine how the framework has been used in implementation projects and research. The purpose of the present article was to critically review and synthesize the literature on PARIHS to understand how it has been used and operationalized, and to highlight its strengths and limitations.</p> <p>Methods</p> <p>We conducted a qualitative, critical synthesis of peer-reviewed PARIHS literature published through March 2009. We synthesized findings through a three-step process using semi-structured data abstraction tools and group consensus.</p> <p>Results</p> <p>Twenty-four articles met our inclusion criteria: six core concept articles from original PARIHS authors, and eighteen empirical articles ranging from case reports to quantitative studies. Empirical articles generally used PARIHS as an organizing framework for analyses. No studies used PARIHS prospectively to design implementation strategies, and there was generally a lack of detail about how variables were measured or mapped, or how conclusions were derived. Several studies used findings to comment on the framework in ways that could help refine or validate it. The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships. Strengths identified included its flexibility, intuitive appeal, explicit acknowledgement of the outcome of 'successful implementation,' and a more expansive view of what can and should constitute 'evidence.'</p> <p>Conclusions</p> <p>While we found studies reporting empirical support for PARIHS, the single greatest need for this and other implementation models is rigorous, prospective use of the framework to guide implementation projects. There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements; greater conceptual discrimination among sub-elements may be necessary first. In general, it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies.</p

Implementation of evidence-based practice for benign paroxysmal positional vertigo: DIZZTINCT– A study protocol for an exploratory stepped-wedge randomized trial

Abstract Background Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, and accounts for 8% of individuals with moderate or severe dizziness. BPPV patients experience substantial inconveniences and disabilities during symptomatic periods. BPPV therapeutic processes – the Dix-Hallpike Test (DHT) and the Canalith Repositioning Maneuver (CRM) – have an evidence base that is at the clinical practice guideline level. The most commonly used CRM is the modified Epley maneuver. The DHT is the gold standard test for BPPV and the CRM is supported by numerous randomized controlled trials and systematic reviews. Despite this, BPPV care processes are underutilized. Methods/design This is a stepped-wedge, randomized clinical trial of a multi-faceted educational and care-process-based intervention designed to improve the guideline-concordant care of patients with BPPV presenting to the emergency department (ED) with dizziness. The unit of randomization and target of intervention is the hospital. After an initial observation period, the six hospitals will undergo the intervention in five waves (two closely integrated hospitals will be paired). The order will be randomized. The primary endpoint is measured at the individual patient level, and is the presence of documentation of either the Dix-Hallpike Test or CRM. The secondary endpoints are referral to a health care provider qualified to treat dizziness for CRM and 90-day stroke rates following an ED dizziness visit. Formative evaluations are also performed to monitor and identify potential and actual influences on the progress and effectiveness of the implementation efforts. Discussion If this study safely increases documentation of the DHT/CRM, this will be an important step in implementing the use of these evidenced-based processes of care. Positive results will support conducting larger-scale follow-up studies that assess patient outcomes. The data collection also enables evaluation of potential and actual influences on the progress and effectiveness of the implementation efforts. Trial registration ClinicalTrials.gov, ID: NCT02809599 . The record was first available to the public on 22 June 2016 prior to the enrollment of the first patients in October 2016.https://deepblue.lib.umich.edu/bitstream/2027.42/146751/1/13063_2018_Article_3099.pd

science

Research article Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementatio