The present protocol has been registered within the Open Science Framework platform (https://osf.io/z8mre). It is reported in accordance with the reporting guidance provided in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement and the PRISMA extension for Scoping Reviews (PRISMA-ScR)  see PRISMA-P checklist in Additional file 1).
Information sources and searches
A search strategy (Additional file 2) was created using a combination of MeSH terms and keyword combinations. We will adapt the search strategy for each database. We will search electronic databases including MEDLINE (Ovid), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, PsycINFO and Web of Science from January 2000 onwards, to reflect current ICU care. We will search for ongoing or completed trials using the World Health Organisation International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/) and systematic reviews via the Cochrane Library. We will search for grey literature using Opengrey (http://www.opengrey.eu/), NHS evidence (https://www.evidence.nhs.uk/), Google Scholar and Prospero. We will scan reference lists of included studies for other studies of relevance. We will exclude editorials, commentaries and animal studies. LA will contact authors where necessary for full-text papers or to enquire about unpublished work identified through protocols or trial registries. A draft search for MEDLINE (Ovid) is available in Additional file 2.
Articles will be selected according to the following criteria for study population, intervention and comparator and study design.
We will include studies recruiting adult patients aged 18 years and older admitted to an intensive or critical care unit, high dependency or a weaning centre, respiratory care unit, or long-term acute care hospital (LTACH), regardless of length of stay. We will also include studies that include family members/caregivers and the healthcare practitioners responsible for the care of these patients as participants.
We will include studies with an active comparator (i.e. another quality improvement tool), a passive comparator (i.e. usual care), and no comparator
We will not make decisions related to inclusion of studies based on outcomes reported.
We will include all qualitative and quantitative study designs including experimental, quasi-experimental, observational studies, and qualitative studies except case series, as this design is not appropriate for the evaluation of a Quality Improvement (QI) tool. For pragmatic reasons we will only include studies published in English. We will include unpublished work in the form of conference proceedings and theses.
One author (LA) will independently screen titles and abstracts to remove obvious exclusions using Endnote X8. The full text of citations selected for potential inclusion will be retrieved and assessed independently by two authors (LA and CA) for eligibility, with a third reviewer (LR) available for arbitration if needed. All decisions will be recorded in an Excel file.
Data charting process
Two authors (LA and CA) will independently extract data using a Google form (Additional File 3) iteratively designed for this review by three authors (LA, CA and LR). The form captures the following variables:
- Participants - participant characteristics (patient/family member/healthcare worker), country, setting (e.g. ICU or weaning unit), admitting speciality).
- Study design – study type and methodology used
- Tool – the type, design, frequency of completion, content and aims of the QI tool described
- Tool development - We will extract data on how the tool was developed, including patient and family involvement and feasibility testing,
- Tool implementation – methods used and evaluated using the Theoretical Domains Framework  to describe barriers and facilitators to adoption.
- Outcomes - The effect of the interventions will be extracted including descriptive data and outcome measures used.
Differences in extracted data between the two reviewers will be resolved by discussion, and a third reviewer (LR) consulted if an agreement cannot be reached. LA will contact corresponding authors for missing information as needed (e.g. tool development or implementation strategies).
Critical appraisal of evidence sources
We will use the results of the MMAT  to help inform conclusions and recommendations from the scoping review, as a robust tool for describing quality of mixed-methods studies. The authors of the tool strongly discourage using stand-alone numerical scores for studies, and so we intend to use the tool as they advise to describe high, medium and low quality studies .
Evidence synthesis, analysis and interpretation
We will complete a PRISMA study flow diagram  to describe our search results. We will provide a narrative synthesis to describe our findings as recommended by Levac et al. .
We will summarise characteristics of included studies, including the setting (type of unit and country) and type of tool used using descriptive statistics.
To address our primary objective we will present tables grouped according to tool type (e.g. checklist, care plan, goal sheet)
describing the purpose and content of each tool. We will include reported outcomes, their measures (if applicable) and the effects of the intervention on these outcomes.
To address our secondary objectives, a table will be produced describing the patients and settings studied in each included tool, and tool development including source of content (e.g. published evidence, expert opinion) and whether patients and family members were involved in its development. Data on methods of tool implementation will be summarised with reported barriers and facilitators interpreted using the Theoretical Domains Framework.