Abstract
BackgroundMany public health interventions based on apparently sound evidence from randomised controlled trials encounter difficulties when being scaled up within health systems. Even under the best of circumstances, implementation is exceedingly difficult. In this paper we will describe the implementation salvage experiences from the Melbourne Diabetes Prevention Study, which is a randomised controlled trial of the effectiveness and cost-effectiveness nested in the state-wide Life! Taking Action on Diabetes program in Victoria, Australia.DiscussionThe Melbourne Diabetes Prevention Study sits within an evolving larger scale implementation project, the Life! program. Changes that occurred during the roll-out of that program had a direct impact on the process of conducting this trial. The issues and methods of recovery the study team encountered were conceptualised using an implementation salvage strategies framework. The specific issues the study team came across included continuity of the state funding for Life! program and structural changes to the Life! program which consisted of adjustments to eligibility criteria, referral processes, structure and content, as well as alternative program delivery for different population groups. Staff turnover, recruitment problems, setting and venue concerns, availability of potential participants and participant characteristics were also identified as evaluation roadblocks. Each issue and corresponding salvage strategy is presented.SummaryThe experiences of conducting such a novel trial as the preliminary Melbourne Diabetes Prevention Study have been invaluable. The lessons learnt and knowledge gained will inform the future execution of this trial in the coming years. We anticipate that these results will also be beneficial to other researchers conducting similar trials in the public health field. We recommend that researchers openly share their experiences, barriers and challenges when conducting randomised controlled trials and implementation research. We encourage them to describe the factors that may have inhibited or enhanced the desired outcomes so that the academic community can learn and expand the research foundation of implementation salvage.
Highlights
Many public health interventions based on apparently sound evidence from randomised controlled trials encounter difficulties when being scaled up within health systems
We recommend that researchers openly share their experiences, barriers and challenges when conducting randomised controlled trials and implementation research
We describe how the need for adjustments to the real world Life! program created challenges for the nested randomised controlled trials (RCTs) and our implementation salvage for the Melbourne Diabetes Prevention Study (MDPS)
Summary
Evaluation roadblocks Encountering unexpected problems while conducting clinical trials is an inherent part of research, as discussed in detail by many authors [1,40,41,42,43,44,45]. To maintain fidelity of the intervention, the MDPS research team improved communication with DA-Vic to have more input over what was being delivered to trial participants This included a partnership agreement between local Life! The issues encountered when implementing the MDPS are similar to those outlined by leaders in population level diabetes prevention initiatives [23,24] They argue that in order for successful execution and sustainability of large population wide diabetes prevention programs consideration needs to be given to factors such as cost and resources, expertise of the research and implementation team, effective participant screening and uptake of the intervention, maintained investment from funding sources, ensuring management systems are of high quality and results are disseminated and utilised in an efficient way to all levels of government, the wider community and individuals. All authors read and approved the final version of the manuscript
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