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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Available from: Jo Rycroft-Malone,
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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.
    BMC Health Services Research 08/2014; 14(1):354. DOI:10.1186/1472-6963-14-354 · 1.71 Impact Factor
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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). "

    Academy of Management Annual Meeting Proceedings 11/2013; 2013(1):14029-14029. DOI:10.5465/AMBPP.2013.14029abstract
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    • "Despite an increasing attention to theory in implementation research, there is still much to learn about theory use and development. In this paper, we report on the findings from a theoretically grounded process evaluation that was embedded in a large trial evaluating implementation interventions [12]. The aim is to provide an explanation of implementation processes, and how this contributes to theory building through the development of the Promoting Action on Research Implementation in Health Services (PARIHS) framework [13-15]. "
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    ABSTRACT: Background: The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework. Methods: The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets. Results: A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes. Conclusions: This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.
    Implementation Science 03/2013; 8(1):28. DOI:10.1186/1748-5908-8-28 · 4.12 Impact Factor
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