December 2, 2024

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Protocol for leading health services innovation: a hybrid type 2 mixed method implementation trial for developing and assessing a codesigned graduate certificate program in health innovation | BMC Medical Education

Protocol for leading health services innovation: a hybrid type 2 mixed method implementation trial for developing and assessing a codesigned graduate certificate program in health innovation | BMC Medical Education

Theoretical framework

The KTA framework is a model designed to facilitate the translation of research findings into practical applications, particularly in the context of health-related innovation [23, 29]. Comprising knowledge creation and action cycle components, the framework guides a systematic approach, emphasizing the adaptation of interventions to specific contexts and incorporating stakeholder involvement (e.g., education modules and skill development for practitioners). It promotes evidence-based practices and iterative processes, allowing for continuous improvement as interventions are implemented and evaluated. By providing a structured pathway from knowledge synthesis to practical implementation and feedback, the KTA framework is a valuable tool for the healthcare sector, ensuring that innovations are grounded in research, contextually relevant, and can lead to a positive impact on health outcomes. For example, as part of the knowledge creation phase, the project team methodically examined both health innovation and learning and teaching strategies to identify how the graduate certificate program could be adapted to include new, flexible and authentic learnings for multidisciplinary health professionals while adhering to the standards for qualifications in education in the Australian Qualifications Framework [30].

Subsequently, the academics adjusted their acquired knowledge to the local context by explicitly evaluating the challenges and enablers affecting the application of curriculum design as part of the action cycle of the KTA framework. For example, newly developed curricula, assessments, and educational tools were codesigned and directed by feedback from alumni, HealthInnTrans (the university’s established health sector advisory network), university learning and teaching experts, and health service management discipline academics. The process of feedback was iterative and initially linear, but we found that we needed the flexibility of returning to groups with specific questions. This provided the necessary flexibility to adapt design knowledge to the specific context.

Experience-based codesign (EBCD) is a methodology that actively involves end-users, including consumers and healthcare providers, to design and improve healthcare services [31]. This collaborative methodology prioritizes user experiences and needs by utilizing a participatory action research process that includes the principles of learning theory and narrative-based approaches to drive transformation. The user-centered approach of EBCD ensures that innovations directly address the real challenges faced by individuals in the healthcare system, enhancing the quality of care and increasing the likelihood of successful adoption. The EBCD process typically includes understanding personal experiences, identifying critical touchpoints, engaging in codesign workshops, and reviewing what has been developed. The codesign process allows all stakeholders to make meaningful contributions. For example, in this project, one crucial touchpoint was including authentic assessments that were not predominantly essay writing. The academic team developed assessment prototypes to align with the Australian Qualifications Framework, and health sector partners provided feedback on these prototype assessment tasks, which assisted them in understanding university requirements.

The RE-AIM framework, encompassing Reach, Effectiveness, Adoption, Implementation, and Maintenance, is a comprehensive tool used to assess the impact and sustainability of the implementation process [32, 33]. Particularly beneficial for codesigned education programs on health innovation, RE-AIM is a holistic approach that considers diverse dimensions, including inclusivity in reach, effectiveness in achieving goals, adoption by relevant entities, implementation fidelity, and long-term maintenance [32, 34]. This framework aligns with the principles of codesign, ensuring that interventions are not only effective but also accessible, acceptable, and sustainable over time. In this study, RE-AIM was used to evaluate the graduate certificate program and the knowledge and skill development of the students in the program.

Study design

Leading Health Services Innovation (LHSI) is a bespoke program designed collaboratively with health sector partners to support the health workforce in innovating, transforming and leading improvements in the healthcare sector. The LHSI program includes a codesigned Graduate Certificate in Health Services Innovation, micro credentialled stackable short courses, roundtables, and conferences. The Graduate Certificate in Health Services Innovation comprises four codesigned courses (syllabus subjects) that combine elements of leadership, facilitating innovation, and achieving successful implementation of new ways of working. The Graduate Certificate will be delivered part-time over two years and is offered in a blended learning mode, combining online, face-to-face and self-directed learning modes.

The aim of this project is to assess the implementation and effectiveness of the codesigned Graduate Certificate in Health Services Innovation for a multidisciplinary health workforce. The program is designed to support the health workforce in innovating, transforming, and leading improvements within the health sector.

In developing this graduate certificate program, we aimed to acknowledge the translational gap between healthcare science and service delivery as a crucial step in codesign. Specifically, tiered codesign protocols were designed to guide the project. This included acknowledging the need to allocate sufficient time and space for feedback from all stakeholders to support the development of a comprehensive understanding of different perspectives related to needs, evidence-based practice, and practical barriers in service delivery. For example, through face-to-face informal meetings, health sector partners provided competence training on practical challenges to the research team. Reciprocally, the academic team provided competence training to health sector partners on obligations such as the standards required for Australian qualifications at the graduate certificate level.

Additionally, the academic team recognized that developing trust, confidence, and a sense of ease was dependent on the quality of the relationships and the mutual connection that comes from a shared vision of developing an innovative health workforce. Robust connections developed because of frequent, sometimes daily, discussions between academics and key health sector personnel, reinforcing the strength of the relationship despite being situated in separate locations. Overall, the codesign process needed to be comprehensive, including attention to input from past alumni, local health sector experts, academic health service experts, learning and teaching curriculum development specialists, and a wider healthcare sector network.

Project aims

This project will use- KTA theory and EBCD to:

  1. 1.

    Co-design a graduate certificate program that incorporates healthcare innovation strategies and principles to provide the health workforce with knowledge, skills and ability to implement accessible, acceptable, and sustainable healthcare improvements. Success will be measured by the completion of the program syllabus, including four co-designed courses and feedback from stakeholders involved in the co-design process. See Fig. 2 for the evaluation phase.

  2. 2.

    Design learning and teaching strategies to develop translatable knowledge and skill development. Effectiveness will be assessed through student evaluations, see Fig. 2.

  3. 3.

    Design authentic assessment that builds on previous knowledge and skills and aligns to Australian Qualifications Framework level 8. The success of the assessments will be evaluated based on student performance metrics.

Fig. 2
figure 2

Evaluation phases of the LHSI program

The evaluation of the project will include the following principles of the RE-AIM framework to:

  1. 1.

    Deliver the graduate certificate courses using evidence-based knowledge and skill development strategies through workshop and online delivery.

  2. 2.

    Explore how co-designed innovation programs can motivate students to achieve competence and confidence in innovation implementation within their health service.

  3. 3.

    Evaluate the implementation and efficacy of the Leading Health Services Innovation program throughout each phase of the project.

The study setting and population

Our partner is one of the largest public hospital and health services (HHS) in the Southern Hemisphere, comprising the full scope of health services, including quaternary and tertiary hospitals, community-based health services and aged care. It is a statutory body governed by a board of directors and is a recognized leader in the provision of world-class healthcare, with expertise in numerous specialties that provides the leverage to expand and drive healthcare forward through research, technologies, and partnership opportunities.

The Academic Team comprises experts from the health services management and health economics disciplines.

Research priorities include knowledge translation and health services innovation through the delivery of an innovative program to connect clinical and business decision-making. The health workforce from this health service and from other Queensland Health Hospital and Health Services have the opportunity to undertake the newly codesigned Graduate Certificate in Health Services Innovation.

Study design

A mixed methods hybrid type 2 [35] clinical effectiveness and implementation trial was adopted for this study. This method is designed for dual testing of clinical intervention (workforce education) and implementation strategy (academic detailing). Direct blending of clinical effectiveness and implementation research aims to improve the speed of knowledge creation and support rapid translation. This hybrid design is motivated by the acknowledgment that traditional effectiveness studies tend to produce effectiveness estimates that are notably different from, and often worse than, the estimates obtained from efficacy studies [35]. The reason for this difference is attributed to the fact that effectiveness studies are frequently conducted under challenging, often “worst case”, conditions. These conditions include limited or no support from the research team during delivery and implementation, a lack of clear understanding about fidelity barriers, and a failure to make efforts to overcome these obstacles. In essence, the hybrid approach addresses these shortcomings and improves the accuracy of effectiveness estimates by incorporating elements from both efficacy and effectiveness studies. In the current hybrid type 2 study, the implementation intervention strategy (health workforce-led improvements) will be evaluated alongside and in support of the codesigned graduate certificate program. This creates a “medium case”, or “pragmatic”, set of delivery and implementation conditions that lie between the best and worst cases, which acknowledges that in real-world applications, studies often encounter a mix of challenges and support.

Sequential phases of data collection and analysis

This study design will involve multiple phases where qualitative and quantitative data are collected and analysed in different phases, allowing for the systematic integration of findings overtime. For this study, it will provide flexibility to adjust based on early findings, making it a good fit for a trial that balances clinical effectiveness and implementation outcomes [36]. In the final integration phase, findings from both clinical intervention and implementation strategy assessments will be synthesised to inform refinements to both components. This process will account for the “medium case” conditions under which the intervention was delivered and implemented, ensuring that real-world challenges and supports are considered.

This approach facilitates iterative testing and continuous refinement based on real-time data, aligning with the hybrid trial objective of accelerating knowledge translation and improving the accuracy of effectiveness estimates in pragmatic settings [36].

Sample size

Primary users of the program are the Hospital and Health Service (HHS) health workforce, defined as practitioners and administrators who are trained by the project team (i.e., administrative support officers, nurses, medical practitioners, allied health) and who are enrolled in the graduate certificate. The two cohorts will commence the program one year apart. Each cohort will consist of staff selected by the HHS with up to forty (40) places per cohort. Cohort 1 commenced July 2023 in the LHSI program, which consists of the Graduate Certificate of Health Services Innovation, three roundtables, and a yearly conference. Cohort 2 commences in July 2024.

Ethics

Ethical approval for this study was obtained from Griffith University (GU Ref No: 2023/566) and the Townsville Hospital Human Research Ethics Committee (HREC/2023/QTHS/100088). This research is considered negligible risk; however, the following key ethical issues have been identified: informed consent and power dynamics; and confidentiality [37, 38]. Informed consent and power dynamic is provided by the participants in the study where they will sign the purposefully designed consent form prior to the commencement of the interviews. The consent form will be contextualized to prevent participants feeling threatened by the format of a standard consent form. In addition, a participant information letter will be provided, outlining the purpose of the study, financial implications, confidentiality, consent implications and support network. Confidentiality is established by the researchers in order to protect the privacy of the individual participant and participating organisations. By using aggregated results in published work, and de-identification of organisations and participants, confidentiality will be maintained. Informed consent will be obtained from all participants prior to any involvement in the study. Consent for online anonymous surveys will be implied by the respondent completing the survey.

Codesign stakeholder group protocol

Program development procedures, materials and assessments will be discussed at regular meetings with a stakeholder group that represents alumni of a previous graduate certificate program undertaken by the HHS, HHS executive and research practitioners, HHS experts and educators, healthcare practitioners, health services and health economics academics, learning and teaching curriculum development experts and the HealthInnTrans network (health sector experts).

Data collection and analysis

Qualitative methods

According to the stage of the project, qualitative interviews will be conducted to identify a) workforce strengths and needs, b) current barriers to healthcare improvements, c) the value of the educational program and each course, d) the efficacy of knowledge translation, and d) satisfaction with the program. A thematic analysis of the interview transcripts and observation narratives will be used for its iterative process of making sense of the data [39]. Themes will be derived from the coded data, this process will be undertaken by two researchers independently. Information will be gathered regarding the intervention’s content, structure, operational methods and any potential changes over time. In addition, the experiences of healthcare professionals, along with facilitators and barriers will be explored. These analyses will provide insights to the projects aims and will assist with quality improvement of the program delivery, educational modules, and fidelity beyond the research project.

Quantitative methods

The National Health Service (NHS) Creating a Culture for Innovation tool [40] will be administered at three timepoints: at the start of the program, at the conclusion of the four courses of the Graduate Certificate and at 12 months post completion for each cohort.

In addition, an adapted version of the Academic Behavioral Confidence (ABC) Scale and the General Causality Orientations Scale (GCOS) [41] will be used at the beginning and end of each of the Graduate Certificate programs for both cohorts 1 and 2 (30–40 participants per cohort) (Fig. 2). The sample size will be restricted by the number of individuals enrolled in the Graduate Certificate. The ABC scale measures constructs of self-concept and self-efficacy and is a psychometric means of assessing the confidence that students have in their own anticipated research skills and study behaviors in relation to their degree program. The understanding that students have of their research skills can be important for making sense of their expectations of teaching, learning and assessment [42, 43]. The adapted ABC scale consists of 10 items that will allow for responses on a 5-point Likert scale. Data analysis will involve descriptive statistics to summarize the data collected from the NHS Creating a Culture for Innovation tool, the Academic Behavioral Confidence (ABC) Scale, and the General Causality Orientations Scale (GCOS). Changes over time will be examined by comparing results across the three timepoints for the NHS tool and between the beginning and end of the Graduate Certificate programs for the ABC and GCOS scales. Paired t-tests or repeated measures ANOVA will be conducted to assess any statistically significant differences in motivation and confidence levels across the timepoints [44]. Additionally, correlation analyses may be performed to explore relationships between participants’ self-efficacy, confidence, and motivation in relation to research and innovation skills. The data collected from these instruments will be used to assess the motivation and confidence levels of the participants in relation to research skills, specifically innovation and implementation, skills and knowledge.

Implementing the codesign process

Codesign of the graduate certificate program began early in the project, with the healthcare organization providing an outline of its aims and objectives for each of the four courses in the program. The university then provided an outline of learning outcomes and scaffolded skill development for each of the courses to the health sector partner to form a basis for starting the codesign process. Once the outlines were agreed upon, course design commenced by codesigning a course profile (subject information). The course profile outlines the course aims, learning outcomes, knowledge and skill development, and assessment criteria. All of these components are codesigned to ensure that the program is responsive to health sector needs. The stakeholder codesign spectrum, shown in Fig. 3, is designed to include more than just consultation and feedback and includes active stakeholder involvement in identifying issues and potential solutions.

Fig. 3
figure 3

Spectrum of codesign approach

The codesign spectrum will be implemented at different stages for the four courses in the graduate certificate. Stage 1 of the codesign process involves the development of a course outline and profile by the academic team. Health sector partner approval is then required to proceed to key stakeholder presentations (alumni, HHS experts, HHS educators, academics and university learning and teaching design experts). A review of the feedback and adjustments are then made to the course outline before proceeding. Stage 2 of the codesign process involves the presentation of the adjusted course profile to the Curriculum Advisory Board (CAB) (University and HHS executives governing the LHSI program). Reviews and further adjustments are made, and the manuscript is resubmitted to the CAB for final approval and support for submission to the Dean Learning and Teaching for university approval. Following this, the course will be developed within an online platform. A local project manager coordinated the codesign process through stage 1 and stage 2.

Evaluating the hybrid type 2 implementation trial

To allow for dual testing of clinical (workforce education) and implementation (academic detailing) interventions and strategies, the project will follow the RE-AIM framework to evaluate the LHSI program. A detailed description of the assessments of the RE-AIM domains is provided in Table 1.

Table 1 Hybrid type 2 evaluation framework

Project timeline

The project began in January 2023 and will continue through July 2027. The first two months involved establishing the codesign process and associated engagement phase of the project. During this period, a Curriculum Advisory Board was established to oversee governance of the project. The next phase involves course codesign, development, and delivery. Ongoing codesign, development, implementation, and evaluation will continue throughout the project. The proposed codesign approach is outlined in Fig. 4.

Fig. 4
figure 4

LHSI codesign project approach

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