NorthStar, a support tool for the design and evaluation of quality improvement interventions in healthcare

Background The Research-Based Education and Quality Improvement (ReBEQI) European partnership aims to establish a framework and provide practical tools for the selection, implementation, and evaluation of quality improvement (QI) interventions. We describe the development and preliminary evaluation of the software tool NorthStar, a major product of the ReBEQI project. Methods We focused the content of NorthStar on the design and evaluation of QI interventions. A lead individual from the ReBEQI group drafted each section, and at least two other group members reviewed it. The content is based on published literature, as well as material developed by the ReBEQI group. We developed the software in both a Microsoft Windows HTML help system version and a web-based version. In a preliminary evaluation, we surveyed 33 potential users about the acceptability and perceived utility of NorthStar. Results NorthStar consists of 18 sections covering the design and evaluation of QI interventions. The major focus of the intervention design sections is on how to identify determinants of practice (factors affecting practice patterns), while the major focus of the intervention evaluation sections is on how to design a cluster randomised trial. The two versions of the software can be transferred by email or CD, and are available for download from the internet. The software offers easy navigation and various functions to access the content. Potential users (55% response rate) reported above-moderate levels of confidence in carrying out QI research related tasks if using NorthStar, particularly when developing a protocol for a cluster randomised trial Conclusion NorthStar is an integrated, accessible, practical, and acceptable tool to assist developers and evaluators of QI interventions.


Background
Clinical evidence is essential to enhance the delivery of care and improve patient outcomes. Yet the transfer of research findings into clinical practice tends to be a slow and haphazard process. One of the central aims of quality improvement (QI) activities is to enhance such transfer. In spite of the growing body of rigorously conducted studies on the effectiveness of various QI strategies [1], the strategies selected for QI activities tend to be based more upon prevailing disciplinary customs and habits than scientific evidence and explicit rationales [2,3].
In 1999, the European Commission (EC) published a report that considered various ways to improve the effectiveness and efficiency of European health care systems [4]. The report recommended work to inform strategies for the effective dissemination and implementation of research findings. The Research-Based Education and Quality Improvement (ReBEQI) project was developed to improve QI research and practice, and respond to the EC recommendations [5]. The project group comprised seven partners in six European countries (Appendix, see Table  4), each with substantial experience in QI research [6]. The project took place over three years (December 2002-November 2005 and was funded by the European Commission's Quality of Life and Management Living Resources 5 th Framework Program. The ReBEQI project had two objectives: 1. To establish a framework for the selection, implementation, and evaluation of interventions to promote evidence-based clinical practice.
2. To provide clinicians, policy-makers, and researchers with a suite of evidence-based, Internet tools, guided by the framework, to inform the development and evaluation of interventions to promote evidence-based clinical practice.
NorthStar is a major product of the ReBEQI project. It is a software program that packages information on the design and evaluation of evidence-based QI interventions into an integrated, easily accessible, and practical tool. In this paper, we provide a general overview of the guiding principles, content development and software development of NorthStar and report its preliminary evaluation. We refer readers to the ReBEQI website for further information on ReBEQI and to see the NorthStar content in full [5].

Guiding principles
The development of NorthStar was guided by four principles. First, the information and tools it offers need to be evidence-based, while being explicit about the limitations of existing evidence. For example, whilst there is a growing body of evidence on the effectiveness of various QI interventions, it is recognised that no single intervention will be consistently effective across a wide range of problems and contexts [1]. Second, NorthStar has to be appropriate to the diverse needs of its target audience, who may have varying levels of skills and experience in quality improvement and research. Third, NorthStar has to be simple to read and navigate to ensure its relevance, acceptability and usefulness.

Content development
The target audience of the tool include QI researchers, healthcare professionals and managers responsible for developing, delivering and evaluating continuing education (CE) and QI programmes at a national or regional level. Consequently, the two areas we covered were the design of QI interventions and their evaluation. The intention was for the tool to be useful to users with varying levels of experience in QI research, and for the text to be instructional as well as informative. For example, when describing the different types of cluster, randomised controlled trials (cluster RCTs), in addition to outlining the features of each type, the text would guide the user with regard to when the use of each design might be appropriate.
A lead individual from the ReBEQI group was identified for each section of the tool according to individual expertise. This lead person took responsibility for preparing the first draft of that section, based on a review of the published literature as well as other outputs of the ReBEQI project (e.g. a literature review of QI models and frameworks). At least two other ReBEQI members reviewed the section. An editor ensured that the different sections were consistent with regard to content, structure and writing style. All group members reviewed the final version for wider feedback and final approval.
The content builds on the framework developed by ReBEQI for the selection, implementation and evaluation of QI interventions. It guides the user on how to identify "determinants of practice" in designing the intervention and on how to design a cluster RCT as the preferred evaluation study design. Determinants of practice are the factors that affect practice patterns and explain the variation in the effectiveness of different QI interventions in changing practice patterns; they are usually categorized as "barriers and facilitators" or as "moderators and mediators" [7,8]. The NorthStar section on cluster RCTs is based, in part, on the Trial Protocol Tool, a product of the Pragmatic Randomized Controlled Trials in HealthCare (PRACTIHC) group [9].

Software development
We developed NorthStar as a Microsoft Windows HTML help system, the standard help system used with Windows 95 and above. This choice gives the tool a familiar Windows interface and provides a range of off-the-shelf functionality. The software for running Windows HTML help, including Internet Explorer upon which it relies, is part of the Windows operating system. The basic HTML help development tool, Microsoft HTML Help Workshop, is available free from Microsoft's website. We also created a web-based version using chm2web by A!K Research Labs [10] that is platform-independent and works with any modern browser.
For the content, we created HTML versions of Word documents using Mozilla 1.4 for Mac OS X. We then linked the HTML documents to the help system in HTML Help Workshop. The HTML documents can contain links to the full spectrum of electronic document formats and can, therefore, include not only textual information but graphics, documents created by other programs, sound, video, as well as links to websites and other programs. Once the HTML documents have been added or updated, the collection is compiled into a single file (a .chm file). The compiled .chm file included the main text of NorthStar, while accompanying documents such as pdf or Word files were organized as external files in the same folder as the compiled .chm file.

Preliminary evaluation
We undertook a questionnaire survey of two groups of potential NorthStar users. The first group comprised eight postgraduate students attending a research methodology course in Göteborg, Sweden. The course focused on the planning of intervention studies within the broader context of health systems research. The second group consisted of 25 individuals, nominated by the seven ReBEQI partners, responsible for developing, delivering, and/or evaluating CE and QI activities. Most of them were based in the ReBEQI partner countries. We surveyed the first group during a class session in 2006, and contacted the second group by e-mail during 2005-2006. We sent nonresponders one e-mail reminder two weeks after the initial contact.
We asked respondents to spend around twenty minutes browsing NorthStar (with no constraints to the browsing sequence) and to fill out a questionnaire. First, we asked respondents about their main professional roles, their roles in CE and QI, and their experience in QI research. We then asked them to estimate the time spent browsing NorthStar and which sections they reviewed the longest. We also asked respondents to use a seven-point scale (1 representing 'not at all,' and 7 'a lot.') to rate their level of confidence with the use of NorthStar, and in carrying out 10 named tasks relevant to QI research. A final question requested open-ended feedback on the format and userfriendliness of NorthStar. A copy of the questionnaire is available as an Additional File. We used descriptive statistics to report aggregated responses from the two groups because of the relatively small number of participants from each.

NorthStar Content
NorthStar consists of 18 sections covering the design and evaluation of QI interventions. After two introductory sections (About NorthStar and Introduction), NorthStar discusses how to involve stakeholders (Stakeholder Involvement). It then examines how to identify and select priorities in order to use resources efficiently (Priority Setting). Next, it provides guidance on how to identify, critically appraise, adapt, and develop relevant clinical practice guidelines (Clinical Practice Guidelines). It also discusses the why, what and how of measuring baseline performance defined as the measurement of actual clinical practice and its comparison to desired clinical practice (Measuring Baseline Performance).
NorthStar discusses what the determinants of practice are and how to identify them using both explorative methods and theory-based methods (Identifying Determinants of Practice). It then provides guidance on what intervention strategy to use, and how to select determinants of practice, and use them to tailor the intervention (Designing the Intervention).
NorthStar assists the user in the choice of appropriate study design to test the QI intervention (Choosing the Study Design). It then discusses the usefulness, limitations, and types of pilot studies (Pilot Studies). The major section of NorthStar is dedicated to the development of protocols for cluster RCTs (Cluster RCT Protocol Tool). Next, it examines when to use and how to design an interrupted times series evaluation (Interrupted Time Series Evaluation). NorthStar reviews two other types of evaluation (Process Evaluation and Economic Evaluation). It also provides guidance on how to form or identify networks of QI researchers, health professionals, health service managers, and policy makers (CE and QI programs). Finally NorthStar provides useful resources (Glossary, Libraries and Web Resources). Table 1 shows the general outline of each of these sections.

NorthStar software
NorthStar is available as an HTML Help system, or as a browser-based version. Figure 1

NorthStar preliminary evaluation
Eight participants from the student group and ten from the ReBEQI nominees responded to the survey (total response rate 18/33; 55%). One respondent from the ReBEQI group provided free text responses only, so we included only 17 responses in the quantitative analysis.
Fourteen (82%) respondents described themselves as health care researchers; others were health care practitioners and managers. Nine (53%) reported intermediate levels of experience in QI research compared with seven (41%) who described themselves as either beginners or having no role in QI research and one (6%) experienced QI researcher. The mean time spent browsing NorthStar was 20.6 minutes. Participants spent most of the time looking at 'Identifying Determinants of Practice' (8/17; 47%) and 'Designing the Intervention' (6/17; 35%). The levels of confidence in carrying out, with the use of North-Star, the ten tasks related to QI research, were all above the

Task
Mean (range) Involve stakeholders in quality improvement intervention research 4.9 (3-7) Identify and select priorities in order to use resources efficiently 5.2 (4-6) Critically appraise clinical guidelines 5.1 (4-7) Measure baseline performance (defined as the measurement of actual clinical practice and its comparison to desired clinical practice) 4.9 (3)(4)(5)(6) Identify determinants of clinical practice 5.2 (4-6) Decide what intervention strategy to use to improve the quality of care 5.4 (4-7) Choose an appropriate study design to evaluate a continuing education or quality improvement strategy 5.5 (5-7) Develop a protocol for a cluster randomised trial 5.7 (5-7) Conduct a process evaluation 5.2 (4-6) Design an interrupted time series evaluation 5.1 (4-6) *Based on a 1-7 scale where 1 = not at all confident and 7 = very confident Journal articles or books referenced in the text

Resources
Useful documents (accessible directly in NorthStar), links to websites, software, and recommended further reading (brief and sometimes annotated bibliography of key references) mid-point of the scale (i.e., four; Table 2). Respondents indicated the greatest confidence in being able to develop a protocol for a cluster randomised trial (mean 5.7) and the least confidence in being able to involve stakeholders in QI research and measuring baseline performance (both means 4.9).
Respondents generally made positive comments about the format and user-friendliness of NorthStar (illustrative comments in the Table 3). Some also mentioned technical problems around its use, while others questioned its major focus on RCTs as the 'gold standard' method for evaluating quality improvement strategies.

Discussion
NorthStar is a tool that aims to support the development and evaluation of interventions to improve the quality of healthcare. Its target audience includes QI researchers, healthcare professionals, and managers responsible for developing, delivering and evaluating CE and QI programmes at a national or regional level.
NorthStar has a number of strengths. The work reflects the collective experience of several established European inter-disciplinary collaborations, but also is based on recent literature reviews and the ReBEQI group's own innovative methodological work. The development of the content employed iterative processes of drafting, reviewing and editing. The resulting content is simple to read, pragmatic and focused on assisting the user in developing and evaluating the QI intervention. In addition, NorthStar is available as both a browser-based version and an HTML help file version, and will soon be available in French and Italian, as well as English. While the focus of NorthStar is on QI programmes at a national or regional level, those in charge of smaller-scale programmes (e.g. local QI initiative) might also find selected components useful.
However, NorthStar has a number of limitations. Because of the limitations of the existing evidence, many recommendations within NorthStar are based on pragmatic interpretations of that evidence. We used structured rather than systematic reviews to draft sections -although these drew upon systematic reviews. In addition, we do intend to incorporate into NorthStar further evidence on the effectiveness of QI strategies as it becomes available.
The results of our modest evaluation suggest that North-Star will form a useful reference and educational tool for QI research in general, and for developing a protocol for a cluster randomised trial, in particular. Potential users seemed mostly interested in the sections that identify determinants of practice and the design of interventions, which are both recognised as challenges requiring greater attention in the implementation field [12]. However, our evaluation of NorthStar was limited by a small sample size, the limited representativeness of participants, the lack of a comparison, and the assessment of intermediate outcomes.
For example, we have not evaluated the impact of the use of NorthStar on the processes and outcomes of development and evaluation of QI interventions. It also is possible that actual or perceived technical barriers to using NorthStar will discourage some potential users.

Conclusion
NorthStar is an integrated and practical tool to assist QI researchers, healthcare professionals, and managers responsible for developing, delivering and evaluating CE and QI programmes at a national or regional level. Our preliminary evaluation is broadly positive. In its current form, NorthStar is mainly designed to meet the needs of QI researchers.

Availability and Requirements
Project homepage http://www.rebeqi.org NorthStar is available from the 'Tools and databases' menu.

Operating system
Windows HTML Help version works in Windows 95 and above. Web-based system works with Linux, Mac OS 9/OS × and Windows.

Other requirements
Windows HTML Help requires that Internet Explorer version 3 or above is installed. The browser-based version requires nothing more than a modern browser.

License
ReBEQI is happy to have its products used for personal and non-commercial use and at no charge in free educational programmes. However, when tuition is charged, ReBEQI royalty fee is 10% of gross receipts. If you are planning to use NorthStar within a for-profit organisation Screenshot from the browser-based version of NorthStar Figure 1 Screenshot from the browser-based version of NorthStar.