>> Innovation fund projects in the area of new forms of care – such as “Structural migration in the middle area of Templin”, or IGiB-StimMT for short – often involve complex interventions. According to Kerkemeyer, these are usually contrasted with simple interventions, although according to her it should be noted here that a clear distinction between the two terms is extremely difficult. According to the inav health economist, the literature defines an intervention as complex if it fulfills one or more of the following characteristics:
• a variety of interacting components.
• a high number of involved patient groups, service providers, organizations or other actors from different social, economic, cultural, ecological or political contexts and settings.
• Interdisciplinarity and multisectorality.
• Multiple indications with corresponding intended outcomes.
• Learning ability and adaptability of the intervention through feedback loops.
• And/or impairment of the effectiveness of the intervention by the behavior of those providing or receiving the intervention.

However, complexity is not necessarily a characteristic of the intervention itself. According to Kerkemeyer, for example, the setting in which an intervention is to be implemented can also be complex. Complex interventions also consist of several individual components that are mutually dependent. The Medical Research Council, which also established the previous definition, has proposed a phase model for the development and evaluation of complex interventions. This model can be compared and described with the PDCA cycle (Plan, Do, Check, Act). First a development is started, then a pilot phase follows, concluded by a comprehensive evaluation that includes reporting, after which the results recognized as successful are to be implemented.
According to Kerkemeyer, the question here is which instruments should be used to evaluate complex interventions. For various reasons, these usually cannot be randomized controlled trials, or RCTs for short, which are considered the gold standard in the evaluation of simple interventions. According to Kerkemeyer, a rethink must take place in the course of evaluating complex interventions. This also has to do with the fact that evaluations in the past have primarily served to demonstrate effectiveness. However, the focus is now increasingly on the fact that evaluations have a “significantly wider spectrum than pure effectiveness assessments”. Instead of proving, the original evaluation purpose of learning is increasingly coming to the fore of evaluation interest. The reason for this is that understanding change processes can sometimes produce a much greater benefit than pure evidence of effectiveness with sometimes only small effect sizes.
When evaluating complex interventions, a mixed methods design is often used, with the term “mixed methods” being used as an umbrella term for various concepts of method combination. Kerkemeyer: “Accordingly, mixed methods can mean that the combination of qualitative and quantitative analysis steps is already firmly designed into the methodology. Or that different, i.e. qualitative and/or quantitative methodological approaches are pursued for a question in different phases of investigation.” And when combining quantitative and qualitative research methods, integration and combination models could in turn be implemented. Here a distinction would be made between preliminary study, generalization and in-depth models.
The evaluation of complex interventions could now be a combination of an umbrella evaluation and/or component-specific individual evaluations. In addition, results, processes and goals should be
Health economic evaluation or at least individual parts must always be taken into account in the evaluation of complex interventions:
• Result evaluation means the comparison between the postulated goal and the ultimately achieved goal state, for example pre-post comparison, target-actual comparison, group comparisons.
• Process evaluation describes the change in processes and structures such as barriers and difficulties in implementation, implementation errors, but also how and when implementation was achieved.
• Health economic evaluation focuses on identifying and quantifying costs and benefits.

Above all, Kerkemeyer is absolutely certain that the evaluation of complex interventions requires “rethinking and creativity”.
What does the evaluation concept look like?
exactly what was used at IGiB-StimMT? This was explained by Michelle Kutscher and Manuel Recker, both research assistants at the Institute for Applied Health Services Research (inav) in Berlin, which was commissioned with the evaluation.
According to Kutscher, a standardized evaluation is not easily possible in an almost unique setting and context such as IGiB StimMT. Kutscher: “The more complex, multi-layered and dynamic an intervention is, the higher the requirements for the evaluation approach are.” Therefore, inav chose the aforementioned mixed methods approach with a combination of qualitative and quantitative for the evaluation of the complex intervention at hand Methods.
The evaluation of IGiB StimMT is based on three pillars:
• The first pillar is the structure and process analysis. This included the collection of structural data, the satisfaction survey of service providers, the stakeholder survey and participant observation.
• The second pillar is the health economic evaluation. An effectiveness analysis and a cost analysis are carried out here, which are calculated using routine data from statutory health insurance and the Association of Statutory Health Insurance Physicians.
• The third pillar is the evaluation of the results of individual care modules. This includes an effect of evaluating the treatment paths and the structured urinary incontinence treatment program using questionnaires.
In order to show what such an evaluation can look like, Kutscher and Recker presented the first results of the sub-projects Coordination and Advisory Center (KBZ), the Medical On-Call Practice (ÄBP) and the Decision Unit (DU), which were analyzed quantitatively using structural data. The structural data collection was again carried out in the sense of an observation or cross-sectional study, whereby the various target parameters for the structural data analysis were determined from different data sources. On the one hand, the data in the project was documented separately, and on the other hand it was drawn from the billing data of the Brandenburg Association of Statutory Health Insurance Physicians, from the hospital information system of the Sana Hospital Templin and from the KBZ documentation software.
According to Kutscher, the structural data analysis served to map the actual use of the new care components and structures of IGiB StimMT by the resident population in Templin in the intervention area. The analysis based on quantitatively collected data would have made it possible to make statements about the degree of implementation of the care offers. To do this, the structural data across the various supply modules were first incorporated into a target/actual comparison. By subtracting the target value from the actual value, a difference would result that would enable an assessment of success and could provide indications as to whether a reversal or readjustment of the respective intervention component might be necessary in certain areas.
In addition to the collection of structural data, other data is also included in the evaluation of the care modules, such as that from the stakeholder survey and participant observation. At IGiB StimMT, the stakeholder survey was carried out using guideline-based interviews at two points in time - at the beginning and at the end of the project. This would have included various multipliers from the Templin middle area, such as the mayor, but also representatives of outpatient general practitioners and specialists and outpatient care services. <<
from:
MVF editor-in-chief Peter Stegmaier

About IGiB-StimMT

The structural migration in the central area of Templin, StimMT for short, is a project of IGiB GbR (AOK Nordost, BARMER, KV Brandenburg) and Sana Kliniken Berlin-Brandenburg GmbH. IGiB-StimMT gGmbH was founded to implement the project. The IGiB-StimMT gGmbH and the other consortium partners (Sana Kliniken Berlin-Brandenburg GmbH, AOK Nordost, BARMER, KV Brandenburg as well as KV COMM GmbH, AGENON GmbH and inav GmbH) aimed to make the regional care structures and processes in the central Templin area demand-oriented and regionally specific to the changing conditions of demographic change. For this purpose, an outpatient inpatient center (ASZ) Templin was built at the site of today's Templin Hospital, accompanied by a renovation and new building. From 2017 to the end of 2020, the project was funded by the Innovation Fund.