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Table 4 Standards for Reporting Implementation Studies study checklist and rationale for choosing measures to report, adapted from Pinnock et al. [55]

From: Study protocol for IMAGE: implementing multidisciplinary assessments for geriatric patients in an emergency department observation unit, a hybrid effectiveness/implementation study using the Consolidated Framework for Implementation Research

STARI Checklist itemExplanationStudy compliant?
Title1Include identification as implementation study and methods usedYes 
Abstract2Include description of implementation strategy to be tested, evidence-based intervention, and key implementation and health outcomes.YesFramework: CFIR
Strategy: Lean Six Sigma
Introduction3Include a description of the problem, challenge/deficiency that intervention aims to address.Yes 
4Include the scientific background and rational for the implementation strategy and any pilot work.Yes 
Aims and objectives5Differentiate between the implementation objectives and any intervention or healthcare outcome objectives.YesAim 1: Implementation
Aim 2: Effectiveness
Methods: description6Include the design and key features of the evaluation and any changes to study protocol, with reasons.YesSingle site, pre-/post-cohort study
7Describe the context in which the intervention was implemented (social, economic, policy, healthcare, and organizational barriers and facilitators that influence implementation).YesPlan to provide updated Table 3 if circumstances change significantly.
8Include the characteristics of the inner setting or target site (locations, personnel, resources, etc.).Yes 
9Include a description of the implementation strategy.YesPlan to report Lean Six Sigma elements, CFIR barriers targeted and concept map
10Describe any subgroups recruited for additional research tasks and or nested studies.Not applicable
Methods: evaluation11Include pre-specified primary outcome and any secondary outcomes of the implementation strategy and how they were assessed.YesGoal of > 80% screening.
12Describe process evaluation objectives and outcomes related to the implementation strategy.Yes 
13Describe methods of capturing resource use, cost, economic outcomes, and analysis.No economic analysis.
14Include rationale for sample sizes.Yes 
15Describe methods of analysis and rationale for this choice.Yes 
16Describe any a priori subgroup analyses.Yes 
Results17Include proportion recruited and characteristics of the recipient population for the implementation strategy.Yes 
18Report the primary and other outcome(s) of the implementation strategy.Yes 
19Report 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 
20Include the resource use, costs, economic outcomes, and analysis for the implementation strategy.No economic analysis.
21Report the representativeness and outcomes of the subgroup recruited for research.YesWill compare to all ED patients and all Obs Unit patients ages ≥ 65 years.
22Report the fidelity to implementation strategy as planned as well as any adaptations to suit context and preferences.Yes 
23Include any contextual changes which may have affected outcomes.Yes 
24Include all important harms or unintended effects in each groupYesMonitoring for unintended effects on ED and Obs Unit operational metrics.
Discussion25Summarize the findings, strengths and limitations, and compare with other studies.Yes 
26Discuss the implications on policy and any potential impact with scaling the intervention.Yes 
General27Include statements on regulatory approvals and trial/study registration.Yes