T HE METHODOLOGICAL APPROACH TO EVALUATE E-NP SERVICE

In 2000, The Medical Research Council (MRC) proposed a framework to develop and evaluate complex interventions that recognised the unique challenges that arise in the evaluation process.

The MRC framework and its published article have often been cited as authoritative guidance on methods of evaluating such interventions (Medical Research Council, 2000). Specific

requirements include a better approach to the development, reporting and implementation of interventions and a greater focus on the contextual features of where the interventions took place (Craig et al., 2013). The MRC has recently updated the original approach with a comprehensive revised guide taking on board the accumulated experiences of researchers that have utilised this approach (Craig et al., 2013). The updated guidelines provided valuable advancements on the original framework, to guide HSR when evaluating complex interventions. The new guideline is intended to help researchers make the appropriate methodological and practical decisions. The model details four key elements to guide the development of a complex intervention though to its evaluation;

o Development

o Feasibility/piloting

o Evaluation

o Implementation

Utilising this approach but modifying it to adapt to the already established service of the E-NP, involves a three-tiered process of ‘development, feasibility and evaluation’ (Figure 2).

Figure 2. Key elements’ of the E-NP framework

Development: Craig et al., (2013) posit that an early task in developing theoretical understanding of innovations is to identify existing evidence and to identify any theories. The discussion in this chapter has identified E-NP service, as a complex intervention; a hybrid service that includes medicine and nursing. Previously it was established that there are multiple interacting

components of the E-NP role and the outcomes of the intervention to be evaluated. The

generation of several hypotheses examining effectiveness of patient and service level outcomes has been formulated.

Feasibility/piloting. Craig et al., (2013) report the importance of good pilot work. Study 1 of this research project provided the necessary groundwork to establish information on patient sample characteristics. The findings from Study 1 guided recruitment, data collection methods and

Development

timelines. Study 2 was a pilot study to test the outcome measures retrospectively and refine primary outcomes for the proceeding study. It also allowed for refining of the data collection forms and spreadsheet for data management and engaged the ED setting for the upcoming RCT to commence. The pilot work across these two studies also established the study feasibility. The E-NP service was able to be evaluated subject to the research design accommodating the

pragmatic features of an intervention that is already in service.

Evaluation. There are many different study designs available to evaluate complex interventions.

Evaluation of E-NP service required a new approach that maintained fidelity to the gold standard of HSR and the design method chosen was an RCT. Craig et al., (2013) suggested randomisation should always be considered as a robust method of reducing bias. Therefore a pragmatic RCT was utilised in this inquiry into E-NP service effectiveness. It was not feasible to ensure double blinding in this study, as the intervention cannot be blinded to the patient groups; identification of the treating practitioner role is an important part of everyday clinical practice. However those involved in data analysis were blinded to the study allocation and the lead investigator was not directly involved ingroup allocation and did not have information about the group code.

The adaptation of the MRC framework (Medical Research Council, 2000) recognises the importance of establishing a theoretical basis for NP interventions (Brazil et al., 2005). This methodological approach builds upon the NP model as a service innovation (Figure 1) within the HSR paradigm to evaluate E-NP service effectiveness. This approach will attempt to understand the relationships between the intervention and the outcomes in two contexts. Namely the:

o Patient care level o Services level

Patient care level

Time to analgesia and pain score outcomes are direct clinical quality of care indicators that can be measured at the patient level. In the context of high demand for ED services, overcrowding and increased waiting times for assessment, such indicators are a reflection of clinically

important benefits for patients. It is essential to highlight that pain is a very common presenting complaint for emergency patients and its effective recognition and management is an important dimension of the quality of care provided in EDs. Time to analgesia and pain score

documentation is one of the mandated clinical indicators implemented by the Australian Council on Healthcare Standards in 2011 (Australian Council on Healthcare Standards, 2011) and hence very appropriate to be measured in examination of E-NP service effectiveness.

Services level

The important clinical indicators of waiting times, length of stay, unplanned representations, and left-without-being-seen rates are essential to ascertain the effectiveness of the intervention at the services level. These indicators are also mandated clinical indicators by the Australian Council of Healthcare Standards (Australian Council on Healthcare Standards, 2011). As ED demand continues to rise it often outstrips enhancements designed to maintain or improve performance.

The ability to examine the benefits the E-NP service has implications for other key clinical indicators that can impact not only the ED service but also a whole of hospital service (Lowthian and Cameron, 2012).

4.4 Summary

The NP model is distinctive in health service delivery as an innovation that operates from within a nursing paradigm with the augmentation of medical and other health professionals’ skills. This conceptual framework was used to guide this inquiry from a HSR paradigm that evaluated NPs as a service innovation at both the patient and service levels. However, the methodological complexities of evaluating NP service called for a new and dynamic approach to research design considering NP service as an intervention that inherently has a number of interacting elements.

To maintain fidelity of the gold standard approach to HSR, a pragmatic RCT was the approach chosen for this research.