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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 item

Explanation

Study compliant?

Title

1

Include identification as implementation study and methods used

Yes

 

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

 

4

Include the scientific background and rational for the implementation strategy and any pilot work.

Yes

 

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

 

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

 

13

Describe methods of capturing resource use, cost, economic outcomes, and analysis.

No economic analysis.

14

Include rationale for sample sizes.

Yes

 

15

Describe methods of analysis and rationale for this choice.

Yes

 

16

Describe any a priori subgroup analyses.

Yes

 

Results

17

Include proportion recruited and characteristics of the recipient population for the implementation strategy.

Yes

 

18

Report the primary and other outcome(s) of the implementation strategy.

Yes

 

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

 

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

 

23

Include any contextual changes which may have affected outcomes.

Yes

 

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

 

26

Discuss the implications on policy and any potential impact with scaling the intervention.

Yes

 

General

27

Include statements on regulatory approvals and trial/study registration.

Yes

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