STARI Checklist item | Explanation | Study compliant? | ||
---|---|---|---|---|
Title | 1 | Include identification as implementation study and methods used | Yes | Â |
Abstract | 2 | Include description of implementation strategy to be tested, evidence-based intervention, and key implementation and health outcomes. | Yes | Framework: CFIR |
Strategy: Lean Six Sigma | ||||
Introduction | 3 | Include a description of the problem, challenge/deficiency that intervention aims to address. | Yes | Â |
4 | Include the scientific background and rational for the implementation strategy and any pilot work. | Yes | Â | |
Aims and objectives | 5 | Differentiate between the implementation objectives and any intervention or healthcare outcome objectives. | Yes | Aim 1: Implementation |
Aim 2: Effectiveness | ||||
Methods: description | 6 | Include the design and key features of the evaluation and any changes to study protocol, with reasons. | Yes | Single site, pre-/post-cohort study |
7 | Describe the context in which the intervention was implemented (social, economic, policy, healthcare, and organizational barriers and facilitators that influence implementation). | Yes | Plan to provide updated Table 3 if circumstances change significantly. | |
8 | Include the characteristics of the inner setting or target site (locations, personnel, resources, etc.). | Yes | Â | |
9 | Include a description of the implementation strategy. | Yes | Plan to report Lean Six Sigma elements, CFIR barriers targeted and concept map | |
10 | Describe any subgroups recruited for additional research tasks and or nested studies. | Not applicable | ||
Methods: evaluation | 11 | Include pre-specified primary outcome and any secondary outcomes of the implementation strategy and how they were assessed. | Yes | Goal of > 80% screening. |
12 | Describe process evaluation objectives and outcomes related to the implementation strategy. | Yes | Â | |
13 | Describe methods of capturing resource use, cost, economic outcomes, and analysis. | No economic analysis. | ||
14 | Include rationale for sample sizes. | Yes | Â | |
15 | Describe methods of analysis and rationale for this choice. | Yes | Â | |
16 | Describe any a priori subgroup analyses. | Yes | Â | |
Results | 17 | Include proportion recruited and characteristics of the recipient population for the implementation strategy. | Yes | Â |
18 | Report the primary and other outcome(s) of the implementation strategy. | Yes | Â | |
19 | Report the process data related to the implementation strategy (Lean Six Sigma), mapped to the mechanism by which the strategy is expected to work (improving capacity, opportunity, or motivation) | Yes | Â | |
20 | Include the resource use, costs, economic outcomes, and analysis for the implementation strategy. | No economic analysis. | ||
21 | Report the representativeness and outcomes of the subgroup recruited for research. | Yes | Will compare to all ED patients and all Obs Unit patients ages ≥ 65 years. | |
22 | Report the fidelity to implementation strategy as planned as well as any adaptations to suit context and preferences. | Yes | Â | |
23 | Include any contextual changes which may have affected outcomes. | Yes | Â | |
24 | Include all important harms or unintended effects in each group | Yes | Monitoring for unintended effects on ED and Obs Unit operational metrics. | |
Discussion | 25 | Summarize the findings, strengths and limitations, and compare with other studies. | Yes | Â |
26 | Discuss the implications on policy and any potential impact with scaling the intervention. | Yes | Â | |
General | 27 | Include statements on regulatory approvals and trial/study registration. | Yes | Â |