A pragmatic cluster randomised trial evaluating three implementation interventions

Centre for Health Related Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK. .
Implementation Science (Impact Factor: 4.12). 08/2012; 7(1):80. DOI: 10.1186/1748-5908-7-80
Source: PubMed


Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.
A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.
Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.
This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.
ISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE).

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    • "These provided an initial framework with which to synthesize the purposively selected texts, which involved annotation, extraction and theming to develop the framework of core concepts. Applying the core concept framework The findings of a cluster-randomized controlled trial to evaluate implementation strategies to address the practice of prolonged fasts before routine surgery included an embedded process evaluation described in full elsewhere (Rycroft-Malone et al. 2012, 2013). A key evidence-based recommendation specifies nil by mouth before induction of anaesthesia should be at 2 hours (RCN/RCoA 2005). "
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    ABSTRACT: AimTo examine the application of core concepts from Complexity Theory to explain the findings from a process evaluation undertaken in a trial evaluating implementation strategies for recommendations about reducing surgical fasting times.Background The proliferation of evidence-based guidance requires a greater focus on its implementation. Theory is required to explain the complex processes across the multiple healthcare organizational levels. This social healthcare context involves the interaction between professionals, patients and the organizational systems in care delivery. Complexity Theory may provide an explanatory framework to explain the complexities inherent in implementation in social healthcare contexts.DesignA secondary thematic analysis of qualitative process evaluation data informed by Complexity Theory.Method Seminal texts applying Complexity Theory to the social context were annotated, key concepts extracted and core Complexity Theory concepts identified. These core concepts were applied as a theoretical lens to provide an explanation of themes from a process evaluation of a trial evaluating the implementation of strategies to reduce surgical fasting times. Sampled substantive texts provided a representative spread of theoretical development and application of Complexity Theory from late 1990's–2013 in social science, healthcare, management and philosophy.FindingsFive Complexity Theory core concepts extracted were ‘self-organization’, ‘interaction’, ‘emergence’, ‘system history’ and ‘temporality’. Application of these concepts suggests routine surgical fasting practice is habituated in the social healthcare system and therefore it cannot easily be reversed. A reduction to fasting times requires an incentivised new approach to emerge in the surgical system's priority of completing the operating list.Conclusion The application of Complexity Theory provides a useful explanation for resistance to change fasting practice. Its utility in implementation research warrants further attention and evaluation.
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    • "Our findings emphasise the role of facilitation and context, respectively, in implementing EBP [33] signifying that the framework was suitable. We found that employing Riks-Stroke in local quality improvement, stakeholders as individuals and teams is vital, facilitating trustworthiness in the data input and outtake as well as initiating quality improvement [34]. Further, the context in terms of management and staff engagement, and its relation to the facilitation of quality improvement, also corresponds to key elements of PARIHS. "
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    ABSTRACT: Background National quality registries (NQRs) purportedly facilitate quality improvement, while neither the extent nor the mechanisms of such a relationship are fully known. The aim of this case study is to describe the experiences of local stakeholders to determine those elements that facilitate and hinder clinical quality improvement in relation to participation in a well-known and established NQR on stroke in Sweden. Methods A strategic sample was drawn of 8 hospitals in 4 county councils, representing a variety of settings and outcomes according to the NQR’s criteria. Semi-structured telephone interviews were conducted with 25 managers, physicians in charge of the Riks-Stroke, and registered nurses registering local data at the hospitals. Interviews, including aspects of barriers and facilitators within the NQR and the local context, were analysed with content analysis. Results An NQR can provide vital aspects for facilitating evidence-based practice, for example, local data drawn from national guidelines which can be used for comparisons over time within the organisation or with other hospitals. Major effort is required to ensure that data entries are accurate and valid, and thus the trustworthiness of local data output competes with resources needed for everyday clinical stroke care and quality improvement initiatives. Local stakeholders with knowledge of and interest in both the medical area (in this case stroke) and quality improvement can apply the NQR data to effectively initiate, carry out, and evaluate quality improvement, if supported by managers and co-workers, a common stroke care process and an operational management system that embraces and engages with the NQR data. Conclusion While quality registries are assumed to support adherence to evidence-based guidelines around the world, this study proposes that a NQR can facilitate improvement of care but neither the registry itself nor the reporting of data initiates quality improvement. Rather, the local and general evidence provided by the NQR must be considered relevant and must be applied in the local context. Further, the quality improvement process needs to be facilitated by stakeholders collaborating within and outside the context, who know how to initiate, perform, and evaluate quality improvement, and who have the resources to do so.
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    • "The change agent role is a skills based role. Effective change agents are valued for their communication skills, people skills, ability to work collaboratively, handle difficult situations and delegate work (Ottaway 1983; Rycroft-Malone et al. 2012; Soo et al. 2009), and have boundary spanning networks. Change agent effectiveness can be improved with training in these skills, whereas champions cannot be trained in enthusiasm (Birkinshaw et al. 2008; Ottaway 1983). "

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