Implement Sci
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Randomized Controlled Trial Pragmatic Clinical Trial
Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India.
Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India. ⋯ The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality.
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Randomized Controlled Trial
A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.
Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. ⋯ This study takes up the challenge to evaluate an efficient strategy for large-scale implementation. Comparing effectiveness and costs of two different approaches, this study will help to define a preferred strategy for nationwide dissemination of best practices.
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Randomized Controlled Trial
A multifaceted feedback strategy alone does not improve the adherence to organizational guideline-based standards: a cluster randomized trial in intensive care.
Organizational data such as bed occupancy rate and nurse-to-patient ratio are related to clinical outcomes and to the efficient use of intensive care unit (ICU) resources. Standards for these performance indicators are provided in guidelines. We studied the effects of a multifaceted feedback strategy to improve the adherence to these standards. ⋯ A multifaceted feedback intervention did not improve the adherence to guideline-based standards on the organizational issues bed occupancy rate and nurse-to-patient ratio in the ICU. The reasons may be a limited confidence in data quality, the lack of practical tools for improvement, and the relatively short follow-up.
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Randomized Controlled Trial
A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.
The uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality. ⋯ This is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings.
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Randomized Controlled Trial
Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.
This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. ⋯ The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting.