Results of the AOK federal evaluations for the legal evaluation of the DMP for the indication type 2 diabetes mellitus

The disease management programs (DMP) aim to improve medical care for chronically ill patients across the board. The goal of the treatment program is to coordinate patient treatment throughout the entire course of a chronic illness and across the boundaries of individual service providers and to optimize the patient's health based on medical evidence. On the one hand, it is about minimizing the “variance” of treatment by the practitioner (Glaeske 2011) and enabling treatment principles for treatment by the medical profession based on medical evidence. On the other hand, the patient should also be actively involved in the treatment process. In the doctor-patient interaction, treatment goals should be set in terms of lifestyle changes or the achievement of medical values. The treatment steps and the health condition are recorded in a documentation form by the treating doctor. As part of the legal evaluation of the DMP, service expenditure and survey data on health-related quality of life are also collected for a sample of patients. This data is linked and evaluated – in a pseudonymized form – at the individual level.

> Due to the nationwide introduction of the DMP without a prior pilot phase, no control groups are provided for in the legal evaluation. It is therefore not possible to carry out randomized control group studies to check the effectiveness of DMP (Beyer et al. 2006). Various studies, initiated by health insurance companies and science, examine the satisfaction of program participants and their health development. According to a Barmer study, DMP patients are more satisfied with the quality of care and the doctor-patient relationship. The positive perception of the support for coping with the illness and the active participation in care design distinguish the program participants from the non-participants. The ELSID study also shows a significantly better assessment of the quality of care for DMP patients compared to non-participants (Miksch et al. 2011). In addition, in a study commissioned by the AOK, type 2 diabetes patients reported an improvement in their health and increased self-control since participating in the AOK's DMP programs (van Lente and Willenborg 2011). The results of the KORA study indicate that the improvements in DMP patients are due to the introduction of structured treatment programs (Stark et al. 2011). Patients are regularly examined and counseled. Critically, this study highlights the lack of evidence that this procedure has the desired positive effect on the medical parameters.
As discussed above, there are no equivalent control groups for the individual DMP programs in the legal evaluation in order to determine effects on the effectiveness of the DMP using a randomized control group design. However, this fundamental decision on evaluation design, which is often criticized in scientific discussions, is contrasted by another important characteristic of legal evaluation: To date, over 1.7 million cases (diabetes mellitus type 2) have been included in the evaluation of the AOK programs.
Evaluation results
The most important risk factors for diabetes mellitus include nicotine consumption, elevated blood pressure (arterial hypertension) and elevated blood sugar levels. An important starting point for therapy in DMP is therefore avoiding or influencing risk factors. Cigarette smoke has a negative effect on metabolism and the cardiovascular system, thereby promoting diabetes-related secondary diseases. The evaluations therefore begin with an analysis of the documented smoking behavior. According to the initial documentation, the proportion of smokers in the group of smokers is, by definition, 100% in the first half of the year of accession (Figure 1). The proportion of smokers fell significantly to 84.6% in the second half of the program participation and fell continuously to 51.5% over the six months of participation. This means that almost half of the former smokers have stopped smoking (see Fig. 1).
Increased blood pressure also has numerous negative influences on the cardiovascular system, which can potentiate diabetes-related complications in the vessels. Close monitoring and (if necessary) medication adjustment of the elevated blood pressure values to the normal range are therefore further therapy goals. For the analyzes of blood pressure development, those patients are considered for whom, according to the anamnesis information in the initial documentation, arterial hypertension is documented as the underlying disease - regardless of whether the patient has already been brought into the normotensive range at this point in time or not.
During the course of their DMP participation, the average systolic blood pressure of these patients drops from 142.3 mmHg in the first half of the year to 139.8 mmHg in the second half of the year to 136.2 mmHg in the thirteenth half of the year. The average diastolic blood pressure drops from 81.4 mmHg at the beginning to 80.3 mmHg in the second half of the year to 78.1 mmHg in the thirteenth half of the year.
Figure 2 shows the development of blood pressure values in a slightly more differentiated manner. For this purpose, the patients are divided into three categories: Category 1 includes patients without hypertension (systolic < 140 mmHg and diastolic < 90 mmHg), Category 2 patients with moderately elevated blood pressure (none of the other two categories) and Category 3 patients with significantly elevated blood pressure ( systolic > 160 mmHg and/or diastolic > 100 mmHg). The assignment to categories 1 to 3 occurs regardless of whether the patients are receiving antihypertensive therapy or not.
The development over time shows a significant increase in the proportion of people in category 1 in the normotensive range. In the first half of the year, 35.6% of patients had normal blood pressure values. After thirteen six months of being part of the program, 52.9% of the patients have a blood pressure value within the normal range. The proportion of patients with moderately elevated blood pressure values drops continuously from 53.9% to 41.6% of patients over time. The proportion of patients with significantly elevated blood pressure drops from 10.5% in the first half of the year to 5.5% in the thirteenth half of the year (Fig. 2).
By determining the proportion of glycolized hemoglobin (HbA1c) as a parameter of diabetic metabolic control, the average blood sugar level over the past (4-12) weeks can be assessed. For example, diabetics whose blood sugar levels are permanently well controlled are significantly better protected against the complications and secondary diseases of diabetes mellitus than those with higher HbA1c levels.
The average HbA1c value in the first half of the year was 7.0%; in the second half of the year it drops to 6.8%. It then increases continuously - in the fifth half of the year it reaches the initial level again and is finally at 7.2% in the thirteenth half of the participation year.
The development of the HbA1c values is shown in more detail in Fig. 3. For this purpose, patients are divided into five HbA1c classes. The proportion of patients with a normal HbA1c concentration (HbA1c values ≤6.0%) decreases continuously from the second half of the year from 24.0% to 12.1% in the thirteenth half of the year. The proportion of patients with an HbA1c value in the upper target range (6.0% < HbA1c ≤ 7.5%) varies between 54.3% in the first half of the year and 60.5% in the tenth half of the year. Among patients with an increased HbA1c value (up to 8.5%), there was an almost continuous increase from 13.3% to 18.5% in the last half of the year from the second half of the year. The proportion of patients with high risk 1 (8.5% < HbA1c ≤ 10.0%) increases continuously from 5.3% to 8.1% from the second half of the year. The group of high-risk patients 2 (HbA1c > 10.0%) increased slightly over time from 1.3% to 2.3% from the second half of the year (Fig. 3).
An important goal in the treatment of diabetes is to prevent or delay the onset of diabetes-related concomitant and secondary diseases. For the associated evaluations, a selection is made of those patients for whom the relevant endpoint is not yet documented in the initial documentation, i.e. there is still a risk of a first incidence. These subgroups are evaluated to determine in which proportion of the respective patients at risk a first incidence is documented. It should be noted that no statements can be made for the accession half year, as this is where the selection takes place, and that special effects are possible in the second half of the year. From the tenth half of the year onwards, a break in the time series can be observed.
This half year the data from the electronic documentation (eDMP) will be included for the first time. The documentation of medical values no longer takes place using a paper documentation form, but rather using a computer-supported electronic form. This is reflected in a clear level effect. However, this does not change the fundamental qualitative trend: a decrease in the documented first incidences over time for most parameters (Fig. 4).
The initial diagnosis of stroke was documented in 0.49% of patients at risk in the second half of their participation. In the third half of the year the proportion is 0.38% and drops to 0.25% by the ninth half of the year. With the introduction of the eDMP documentation, which will be reflected from the 10th half of the year, there is an increase in documented first incidences to 1.3%. This share value declines continuously in the following six months to 0.46% in the thirteenth half of the year. The proportion of patients diagnosed with a heart attack for the first time drops from 0.44% in the second to 0.24% in the third to 0.15% in the ninth half of the year. With the introduction of the new documentation, an increase in documented first incidences to a proportion of 0.29% can also be seen here. As the process progresses, this proportion drops to 0.18%.
A severe foot status (foot lesion defined as Wagner stages 2 to 5 and/or Armstrong stages C to D) is documented for the first time in 0.39% of patients in the second half of the year and 0.31% in the third half of the year. This proportion drops continuously to 0.20% in the ninth half of the year. With the change in the documentation method, there is an increase to 0.28% of patients, which decreases to 0.23% over time. The proportion of patients with a documented amputation for the first time is 0.11% in the second half of the year and fluctuates - with low absolute values - between 0.05% and 0.07% between the third and ninth half of the year. With the introduction of the new documentation method, an increase can also be noted here. As the disease progresses, the documented initial incidences decline to 0.10%.
The proportion of patients with nephropathy documented for the first time drops from 1.11% in the second half of the year to 0.81% in the third half of the year to 0.43% in the ninth half of the year. Due to peculiarities in the recording of nephropathy since the introduction of the new documentation method, no values are reported for the following six months. Blindness was first documented in 0.03% of patients in the second half of the year and in 0.02% in the third half of the year. Until the ninth half of the year, this share value fluctuates – with low absolute values – between 0.01% and 0.02%. With the change in the documentation method, there is an increase in the share value to 0.04%, which subsequently falls to 0.01%. Since these values would hardly be visible in the scaling in Figure 4, their graphical representation is omitted (Fig. 4.).
discussion
In summary, the longitudinal analysis of over 200,000 patients shows a positive development in important indicators. The proportion of smokers and the blood pressure values of the program participants decreased significantly. As the HbA1c value develops, there is a slight increase over time. In addition, when it comes to important concomitant and secondary diseases, it can be observed that the proportion of patients at risk with documented first incidences is decreasing.
When interpreting the results, it should be noted that, by definition, the cases considered do not contain any patients who have dropped out and therefore no patients who died during the observation period. This suggests systematic effects on the morbidity of the patients under consideration. In fact, the comparative evaluations show that the medical parameters considered would be less favorable if all cases were included in the evaluation (including the eliminated patients). However, this is a level effect; the qualitative progression would remain the same: the parameters considered improve over time.
The increase in documented incidences since the introduction of electronic documentation forms should be critically assessed. A comprehensive explanation of this phenomenon is currently missing. This method effect makes it difficult to make statements about the actual number of incidences. However, the observed trend remains despite the observed shift in levels between the ninth and tenth half of the year: the proportion of patients at risk with documented first incidences generally decreases. This is remarkable given that the age and duration of illness of the patients examined have increased by an average of six years. In general, the probability of endpoints occurring for the first time increases with increasing age. It can be assumed that the observed results arise from an interaction of different influencing factors, which should be the subject of further research activities. <<

method
The most current results of the legal evaluation of the disease management program (DMP) “AOK Curaplan Diabetes Mellitus Type 2”, which is carried out by infas, WIAD and Prognos on behalf of the AOK, have been available since September 30, 2011. An evaluation at federal level is created for the AOK Federal Association based on this data. Accordingly, descriptive evaluations are carried out on a case basis, in which the results are differentiated according to how many semesters of their participation in the program the participants are in. The entry cohorts from 2003-1 to 2004-1 are evaluated. In order to obtain a population that is stable over time for the longitudinal observation, all program participants or cases from the three half-year cohorts (program entry between January 1, 2003 and June 30, 2004) are selected who participate in the DMP without interruption at least until the thirteenth half-year of participation. This is a total of 209,476 patients. Of these, 56.7% are women and 43.4% are men. The average age of these patients is 65.8 years in the first half of the year. The focus of this article is on the accompanying and secondary diseases (heart attack, stroke, diabetic foot, nephropathy, amputation), the risk factors (development of blood pressure values, smoking) and the long-term blood sugar value HbA1c.