Process evaluation of a multi-disciplinary complex intervention to improve care for older patients with chronic conditions in rural areas (the HandinHand Study): study protocol

Demographic change, increasing health care needs and consumer expectations highlight the need for transforming and restructuring healthcare services worldwide [26]. With a growing population of people over 60, healthcare systems are faced with challenges to meet growing demands within a context of a shortage of healthcare professionals. Most older people are able to care for themselves, but in later life many also suffer from one or multiple chronic illnesses and disabilities and require support from healthcare professionals. Health care needs of persons with chronic health conditions are multi-fold and complex and cannot be adequately met by one health profession alone. Rather, care models involving multidisciplinary teams and coordinating services to include a mix of skills and competencies tailored to the complex needs of persons with chronic conditions have shown to improve outcome [15, 21].

Particularly for people in rural areas, many countries have responded to growing demands for multidisciplinary care models acknowledging evidence of the importance of person-centred care approaches enabling support and empowerment for self-management at home for people with chronic conditions [8, 19]. In many countries, models of community-based, ambulatory care have been proposed instead of models of acute medical care provided mostly by hospitals aiming to increase health care access and reduce potentially avoidable hospitalisations [20, 21].

In primary care, the effectiveness of traditional, physician-driven models have been questioned and alternative models were successfully implemented [15]. Collaborative, integrated care models have been shown to have a positive impact on a number of patient outcomes in a variety of primary care settings [21]. New opportunities have emerged for nurses, especially advanced practice nurses (APN), to meet patients’ demands and unmet needs [1‐4, 11, 19]. Internationally, APN claim essential roles as practitioners within health care systems and are in a prime position to drive innovative care models to improve the coordination of multidisciplinary health care for older people [19]. Advanced nursing practice has been defined as “patient-focused application of an expanded range of competencies to improve health outcomes for patients and populations in a specialized clinical area of the larger discipline of nursing.” (Tracy & O´Grady, [30]). Current evidence suggests that when APN are competent and empowered within the health system to practice as independent professionals, their work is associated with improvements in several measures of health outcomes and behaviour and leads to comparable or better results compared to care provided by medical doctors alone [17, 18].

In Germany, the establishment of educational and practice opportunities for nurses to become APN started later and developed slower than in many other Western countries, and the German health system still faces important legislative, professional and structural barriers that prevent APNs (or indeed any nurse) to practice as independent professionals. A re-organisation of health care provision and greater autonomy for nursing practice has been recommended by various legislative and professional bodies in Germany for many years but so far, the legal framework for such independent provision of healthcare by nurses is lacking [6, 27, 28]. In Germany, nurses are not entitled to bill for healthcare provided, refer patients to other health professionals, or prescribe drug or nursing aids. Nurses are authorised to practice medical care e.g. wound care management only upon delegation and referral from medical professionals. Also, academic educational opportunities for nurses beyond basic training in the form of tertiary education have developed much later than in most developed countries. Hence, from a global perspective, the development of APN roles and opportunities in Germany is clearly delayed and there is a dire need for concerted efforts to increase evidence-based advanced and expanded practice opportunities.

The “HandinHand” (HiH) study, funded by the German Innovation Fund of the Joint Federal Committee [9], addresses the development and evaluation of expanded nursing roles within an innovative, multidisciplinary care model in primary care. The study will investigate the effects of a complex intervention that aims to improve outcomes for community-dwelling older people with chronic conditions. The core of this intervention will be the implementation of an Expert Nursing Centre (ENC), comprising a team of qualified nurses with expanded practice competencies and additional tertiary nursing education at Bachelor-level working in collaboration with general practitioners (GPs) and other health care professionals (HCP). Successful development, implementation and utilisation of any new role is complex, particularly in multidisciplinary teams [29]. Therefore, a comprehensive process evaluation will be undertaken alongside the main study to explore barriers and facilitators regarding implementation, mechanisms of impact and the context of the study. This paper describes the process evaluation, including design and methods.

The comprehensive process evaluation will enable to obtain important indications at different levels as to which hindering and facilitating factors need to be taken into account in the future. Because of the complexity and the need to gain the relevant insights, the challenge will be to limit the analyses to the core questions and handle the amount and potential incommensurability of data. To overcome this challenge, the logic model will provide orientation and structure and will help to focus [23].

The MRC framework addresses further key recommendations for process evaluations [23] that need to be discussed. As there will be a separation between the process and outcome evaluation, the methods and timing of the data collections with the institutions responsible for the outcome evaluation (RWI) were discussed in advance and synergies were identified. The cooperation and communication is constructive and trusting. In addition, a representative of the RWI is a permanent guest at the meetings of the advisory board. Advisory support was provided by the research team in the development of the intervention. If required, different aspects of the intervention and nursing sciences in general are discussed between the EN team leader and the research team. As the research team is aware of the need to remain credible evaluators, they will reflect their role and the potential impact on the research process regularly within the research team.

As the intervention, for which the TIDieR instrument was used [12], was discussed in detail in the project advisory board and between the HiH core team and the research team, a precise description of the intervention exists. Changes made after four months were recorded accordingly.

The recommended entry level for ANP is Master-level tertiary education (ICN, [13]). Given the late development of Master-level tertiary education for nurses and that there are still hardly any APNs working regularly in primary care in Germany, the implementation of the ENC comprising ENs with an additional tertiary nursing education at Bachelor-level can be an important intermediate step to advance the development of nurses with expanded roles. At this level, nurses are provided with the skills and competencies required for evidence-based expanded practice. At the same time, the roles for this type of practice will need to be developed and evaluated in terms of scope, effectiveness, and integration into the existing healthcare system. Such roles could pave the way for an expanded, autonomous nursing practice towards ANP implementation in Germany to improve care for older people with chronic illnesses. As this complementary role of nurses does not yet exist in this setting, there will be a special focus on the development of the role of the ENs and their competencies as well as their scope of practice within the process evaluation.

The chosen methodological approach has several advantages. The applied mixed methods approach allows to measure key variables quantitatively as well as qualitative. This will enable to build upon quantitative findings more precisely in interviews or focus groups. In addition, all core participants and relevant stakeholders will be interviewed several times during the course of the project, so that the perspectives at different levels can be considered. To avoid collecting unnecessary data, smaller purposively selected samples have been chosen.

It will be essential to integrate relevant unpredictable contextual factors such as the COVID-19 pandemic into the data collection, which is why all interviewees will be asked about the influence of the pandemic. In the course of data collection, some planned data collections needed and will need to be postponed due to the COVID-19 pandemic and some data collection methods were and will be adapted, i.e. changing from face-to-face to video interviews or from focus groups to individual interviews.