The primary aim of the disease management program (DMP) for patients with diabetes mellitus type 2 is to improve the quality of health care and the treatment process. 12 years after its introduction in Germany, there is still no consensus as to whether DMP has been effective in reaching these goals.
Methods
A retrospective longitudinal population-based study between 2004 and 2015 were conducted to evaluate the DMP for type 2 diabetes in Bavaria using routinely collected patient medical records hold from the National Association of Statutory Health Insurance Physicians of Bavaria.
Results
During the first 12 years of DMP, the number of participants increased continually to reach 580,222 in 2015. The proportion of participants older than 70 years increased during the observation from 41.6 to 51.1%. The percentage of smokers increased slightly from 9 to 11%. Similarly, the distribution of body mass index remained constant with approximately 50% of patients having a body mass index >30 kg/m2. Control of HbA1c was without an appreciable change over the course, with between 8.3 and 9.4% of all patients with uncontrolled values higher than 8.5%. Prescription of metformin increased from 40.5% in 2004 to 54.1% in 2015. Among patients receiving insulin, the proportion receiving a combined therapy with metformin increased from 28.4% in 2004 to 50.8% in 2015. In contrast, the percentage with insulin monotherapy decreased from 55.4 to 33.7%. The proportion of patients with a diabetic education increased within the course from 12.8 to 29.3%.
Conclusion
Data from the German DMP for type 2 diabetes demonstrates an improvement in the quality of care with respect to pharmacotherapy and patient education and therefore to an improved adherence to guidelines. However, no appreciable improvement was observed with regard to smoking status, obesity or HbA1c control.
Hinweise
Michael Mehring and Ewan Donnachie are co-first authors
Background
Chronic diseases are one of the main causes of increased morbidity and mortality risk worldwide [1]. Diabetes mellitus was once a disease of concern almost exclusively in developed western industrial nations, but is now also increasingly an issue in developing countries. Worldwide, the number of adults with diabetes worldwide has more than doubled in the last 3 decades [2]. Diabetes mellitus is a chronic disease often associated with serious complications such as retinopathy, nephropathy, neuropathy, ischemic heart disease, peripheral vascular disease and cerebrovascular disease. Its global burden to public health systems and high potential for a deep impact on economies worldwide motivate further research to improve the management of patients with diabetes mellitus.
In Germany, disease management programs (DMP) for diabetes and other chronic conditions were introduced between 2003 and 2007. The aim was to improve the quality of health care and the treatment process [3]. Currently, more than 7.7 million statutorily insured patients in Germany are enrolled in one of the six disease management programs [4]. As of present, there are DMPs for patients with breast cancer, diabetes type 1 and type 2, coronary heart disease (CHD), asthma and chronic obstructive pulmonary disease (COPD). Further DMPs are currently being planned for patients with chronic heart failure, depression, and chronic back pain. Although 4.04 million statutorily insured patients took part in one of 1.723 registered DMPs for type 2 diabetes in 2015, it is still highly debated how effective these programs in Germany are [5] and if they have achieved their goals. The main reason for this nescience is that the DMP were introduced at a national level without incorporating a valid randomized or pseudo-experimental evaluation design [6]. Besides the methodological issues, interpretation of the available findings is further complicated by conflicting interests, for example due to the initial coupling of the DMP with the financial risk adjustment scheme for health care insurances. For this reason, we limit ourselves to a purely descriptive analysis of the DMP between 2004 until 2015 in order to assess how the structure and treatment of this patient collective has developed.
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A central intention of the German DMP was to introduce a data-driven system for continuous quality improvement [7]. For evaluation and quality improvement purposes relevant data on each patient is collected in a standardized procedure. The present investigation therefore assesses whether key indicators for quality improved during the first 12 years of DMP in Bavaria. In general studies investigating the utility of type 2 diabetes mellitus DMPs have come to varying conclusions. Some of these studies suggest that the German DMPs have improved the quality of care [8, 9]. Other studies showed no improvements for DMP-diabetes participants [10, 11].
Methods
The German DMP for diabetes mellitus type 2
In 2001 a committee of experts reporting to the German Federal Minister of Health criticized what they had identified as deficits in routine care of chronically ill patients, including those with diabetes mellitus type 2 [12]. A DMP was suggested as a quality program to facilitate the continuous improvement of this care. In the end the DMP for diabetes mellitus type 2 was accredited by the German Federal Insurance Agency (German: Bundesversicherungsamt) in 2002 and introduced in Bavaria in July 2004. Its aim is to improve long-term care by establishing standards for diagnosis, treatment, documentation, quality assurance and referral, whilst requiring active patient participation. In parallel to the introduction of DMP, the national diabetes mellitus type 2 guideline [13] was developed and brought into effect as a guideline for the German health care system. In order to enroll a patient into the DMP diabetes mellitus type 2, the diagnosis needs to be confirmed and documented by the coordinating general practitioner according to established criteria. Participating patients receive a quarterly or half-yearly check-up by their coordinating GP, with the interval decided by the physician based on symptom severity and overall patient health. A centralized reminder system for patients and practices helps to ensure that these regular consultations are not overlooked. Health insurance companies support their patients with structured information to assist self-management and by providing other insurer-specific incentives (e.g. until its abolition at the end of 2012, a quarterly consultation fee of €10 was waived for DMP patients). Physicians commit to treat patients according to evidence-based guidelines. To this end, a standardized medical record is completed at each check and submitted to various official agencies for quality assurance purposes. This file contains details of the physical examination (vital parameters and comprehensive foot examination including pulses), HbA1c, presence of albuminuria, medical history, diabetes related and antihypertensive medication, patient education for diabetes and hypertension, a patient-specific HbA1c target agreement, documentation of hospitalization or emergency treatment and referrals to a diabetologist or other specialist. The DMP diabetes mellitus type 2 was underpinned by the introduction of additional quality improvement measures. GPs receive half-yearly feedback reports to benchmark their performance on the basis of agreed quality indicators (e.g. percentage of patients with an HbA1c >8.5%). Additionally, participating GPs are obliged to complete continuous diabetes-specific medical education at least once every 3 years. These medical education programs are provided by various commercial and non-profit organizations including the National Association of Statutory Health Insurance Physicians of Bavaria (German: Kassenärztliche Vereinigung Bayerns—KVB). Finally, the KVB utilizes CME events and its members’ journal to engage coordinating physicians in the process of quality improvement.
Statistical evaluation
Patients medical records in pseudonymised form were analyzed by the National Association of Statutory Health Insurance Physicians of Bavaria. A retrospective longitudinal population-based study was conducted between 2004 and 2015. The data were analysed in a pure descriptive manner. Statistical analysis was conducted using the R environment for statistical computing [14].
Results
Since the introduction of DMP, the number of participating patients has increased steadily. Whereas in the first year 2004, a total of 249,227 patients were enrolled, this number has more than doubled over the first 12 years (Table 1). While the distribution of gender remained constant over the entire observation period, the age distribution of the DMP collective increased steadily. The percentage of smokers increased slightly up to 11.2% in 2015. Similarly, no appreciable change can be observed in BMI. The percentage of patients with a BMI between 18.5 and 29.9 kg/m2 decreased slightly, while the percentage with BMI ≥35 kg/m2 increased and the group between 30 and 34.9 kg/m2 showed no substantial change. The numbers of participating physicians increased from 5525 at program begin in 2004 to 8257 in 2015. These are predominantly general practitioners (97%), followed by internists, diabetologists or endocrinologists (1.2%) and other physicians in private practices (0.7%).
Table 1
Patients baseline data
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
No. patients
n
272,230
322,407
353,818
405,495
443,943
475,418
506,221
532,394
557,679
565,262
574,249
580,222
Age
0–30
n
603
619
684
893
1072
1189
1298
1473
1589
1594
1665
1678
%
0.2
0.2
0.2
0.2
0.2
0.3
0.3
0.3
0.3
0.3
0.3
0.3
31–40
n
3488
4086
4519
5140
5698
6165
6496
6828
7195
7221
7602
7846
%
1.3
1.3
1.3
1.3
1.3
1.3
1.3
1.3
1.3
1.3
1.3
1.4
41–50
n
15,658
18,902
20,723
23,847
26,157
28,523
30,524
32,418
33,870
33,973
33,838
33,875
%
5.8
5.9
5.9
5.9
5.9
6.0
6.0
6.1
6.1
6.0
5.9
5.8
51–60
n
44,330
53,046
59,448
68,438
73,860
77,242
80,621
83,833
86,929
87,328
89,379
91,179
%
16.3
16.5
16.8
16.9
16.6
16.2
15.9
15.7
15.6
15.4
15.6
15.7
61–70
n
94,715
108,701
114,317
126,291
134,234
138,947
142,553
143,662
146,125
147,232
148,731
149,458
%
34.8
33.7
32.3
31.1
30.2
29.2
28.2
27.0
26.2
26.0
25.9
25.8
71–80
n
81,740
97,102
108,561
126,700
141,195
154,850
169,104
181,978
192,709
194,937
196,654
195,301
%
30.0
30.1
30.7
31.2
31.8
32.6
33.4
34.2
34.6
34.5
34.2
33.7
80+
n
31,696
39,951
45,566
54,186
61,727
68,502
75,625
82,202
89,262
92,977
96,380
100,885
%
11.6
12.4
12.9
13.4
13.9
14.4
14.9
15.4
16.0
16.4
16.8
17.4
Female gender
n
106,443
139,086
162,025
193,781
220,973
241,668
257,076
270,660
283,446
286,676
290,607
292,302
%
51.5
51.3
51.2
51.1
50.9
50.9
50.8
50.9
50.8
50.7
50.6
50.4
Smoker
n
24,544
27,147
29,236
33,277
39,754
44,172
48,549
53,115
57,421
59,631
62,545
64,959
%
9.0
8.4
8.3
8.2
9.0
9.3
9.6
10.0
10.3
10.5
10.9
11.2
BMI
0–18.5
n
446
176
149
147
1532
1794
1845
1935
2029
2080
2208
2178
%
0.6
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
0.4
18.5–24.9
n
9782
5202
4848
4794
52,452
58,783
61,942
64,878
67,348
68,076
68,603
69,645
%
13.7
12.5
12.3
12.7
12.5
12.5
12.3
12.2
12.1
12.1
12.0
12.0
25.0–29.9
n
28,650
16,202
15,056
14,162
160,124
178,845
189,735
198,157
206,727
208,359
210,000
210,317
%
40.0
39.1
38.2
37.5
38.3
38.0
37.7
37.4
37.2
37.0
36.7
36.3
30.0–34.9
n
20,872
12,312
11,726
11,008
125,014
140,792
150,947
159,081
166,511
168,794
171,675
173,238
%
29.1
29.7
29.7
29.2
29.9
29.9
30.0
30.0
30.0
29.9
30.0
29.9
35.0–39.9
n
8101
5033
4991
4903
52,728
60,226
65,537
70,023
74,078
75,821
77,638
79,152
%
11.3
12.1
12.7
13.0
12.6
12.8
13.0
13.2
13.3
13.5
13.6
13.7
40+
n
3805
2557
2677
2728
26,168
30,646
33,898
36,464
39,052
40,550
42,669
44,260
HbA1c >8.5%
n
22,821
28,588
30,563
36,343
36,264
42,762
47,335
49,624
52,187
50,426
47,825
47,951
%
8.4
8.9
8.6
9.0
8.2
9.0
9.4
9.3
9.4
8.9
8.3
8.3
Patient education
n
34,840
73,454
89,348
106,870
125,175
137,569
147,672
156,205
162,850
165,923
168,197
169,877
%
12.8
22.8
25.3
26.4
28.2
28.9
29.2
29.3
29.2
29.4
29.3
29.3
DMP diabetes mellitus Typ 2: 2004–2015
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The analysis of the prescribed medication reveals a number of distinct findings (Table 2). The most imposing result is a clear increasing trend in the prescription of metformin. Whereas in 2004, 40.5% of all patients were prescribed metformin, this share increased to 54.1% in 2015 (Fig. 1).
Table 2
Medication
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Antihyperglycemic medication
n
206,015
246,453
270,251
309,867
344,343
367,046
390,126
406,919
421,065
422,019
423,640
425,342
%
75.7
76.4
76.4
76.4
77.6
77.2
77.1
76.4
75.5
74.7
73.8
73.3
Metformin
n
110,237
139,903
160,445
192,346
223,018
245,607
269,810
288,871
303,841
307,339
310,177
314,075
%
40.5
43.4
45.3
47.4
50.2
51.7
53.3
54.3
54.5
54.4
54.0
54.1
Insulin
n
67,491
79,835
88,270
100,335
108,872
113,476
117,963
121,185
125,045
126,496
128,680
131,760
%
24.8
24.8
24.9
24.7
24.5
23.9
23.3
22.8
22.4
22.4
22.4
22.7
Of which
Monotherapy
n
37,378
42,517
45,574
50,090
51,680
51,583
51,011
50,229
49,289
47,134
45,397
44,347
%
55.4
53.3
51.6
49.9
47.5
45.5
43.2
41.4
39.4
37.3
35.3
33.7
With metformin
n
19,182
24,691
29,586
35,946
41,452
45,734
50,160
53,992
58,085
60,871
63,473
66,900
%
28.4
30.9
33.5
35.8
38.1
40.3
42.5
44.6
46.5
48.1
49.3
50.8
DMP diabetes mellitus Typ 2: 2004–2015
Fig. 1
Distribution of prescribed medication by 2004–2015
×
Simultaneously, the prescription of insulin decreased slightly over the course from 24.8% in 2004 to 22.7% in 2015. Additionally the use of an insulin monotherapy declined significantly from 55.4% in 2004 to 33.7% in 2015, the combination of metformin and insulin increased steadily from 28.4 to 50.8%. The proportion of patients with a successfully completed diabetic education increased within this period from 12.8 to 29.3%. The proportion of patients with an HbA1c value higher than 8.5% showed over the course a marginal short-term increase from 8.4 to 9.4%, decreasing again to 8.3% of all patients in 2015.
Figure 2 shows the distribution of grouped HbA1c values by year. Over the entire course of the observation, the proportion of patients with an HbA1c value above 8.0% remained approximately constant at around 20%. The proportion of patients with HbA1c below 6% exhibits a U-shaped development, decreasing from 22 to 12% by 2010 and then increasing to 20% of patients by 2015.
Fig. 2
Distribution of grouped HbA1c values by 2004–2015
×
Discussion
The main results of the present evaluation are increased prescription rates of metformin and the combination of metformin and insulin since the implementation of DMP for diabetes in Bavaria in 2004. At the same time, the proportion receiving insulin decreased and, among these patients, insulin monotherapy became less common.
Since the early 1990s, disease management programs for diabetes mellitus have been implemented in many countries to improve quality of life and treatment process and to reduce healthcare expenditures. In Germany, the DMP for patients with diabetes mellitus type 2 was introduced nationwide starting in 2002. However, an adequate evaluation scheme, for example by means of a cluster-randomized controlled trial, was not implemented and so a retrospective causal analysis is difficult to perform and necessarily limited. A comprehensive program evaluation requires a control group design. We therefore present a purely descriptive analysis charting the development of the program between 2004 and 2015. Previous findings revealed already for example within an observational study of 11,079 patients over 3 years an association between reduced mortality and the participation in a German DMP for diabetes mellitus type 2 [9]. Laxy et al. [15] found a clear positive impact of guideline care and increased self-management for patients within a DMP. A recent published evaluation of the Austrian DMP for patients with type 2 diabetes mellitus showed within a propensity score matching analysis a clear survival and cost benefit for DMP participants compared to non-participants [16]. Another recent findings showed that the participation of a German DMP has a positive impact on HbA1c values [17]. Sönnichsen et al. found within a cluster randomized trial that the process quality enhances of DMP participants without an improvement of the metabolic control [18]. Additionally a recent systemic literature review [19] from German DMPs for type 2 diabetes found besides a lower overall mortality also an improvement in process parameters from DMP participants. Some of the already existing results are in line and were largely corroborated by our present descriptive findings. The present findings are solely descriptive and do not raise the claim to prove the above mentioned associations, but some of the previous methodological limited findings from the German DMP were supported by our present descriptive results.
In particular the increasing prescription of metformin reflects a stronger adherence to guidelines, with metformin almost universally recommended as a first-line drug treatment [13, 20]. This is justified by good tolerance, few side effects, a decrease in HbA1C by 1.5–2%, avoidance of hypoglycaemia, decrease in body mass index, proven positive effect on cardiovascular complications and mortality, high therapy compliance rate and low treatment costs. Additionally the improvement of the diabetes education reflects an initial increase in guideline adherence, but the almost unchanged saturation level between 2011 and 2015 suggests that further efforts are needed to promote patient education. The observed improvements in diabetes care may conceivably have been achieved by the accompanying quality improvement strategies as outlined in the methods section. Individual feedback reports and medical education schemes are known to be effective to improve the quality of chronic care [21, 22]. However, a further development and support of establishing standards for diagnosis, treatment, documentation, quality assurance, and enhancing active patient participation is still desirable and in the sense of a better patient care.
Two previous reviews [23, 24] concluded that a DMP lead to a modest extent to an improvement of a glycemic control. Otherwise, a systematic literature review, conducted in 2012 came to the conclusion that the analyses regarding the effectiveness of DMPs were not feasible due to heterogeneity of study designs [25]. The present results in regard to the glycemic control are hard to interpret without a comparison group. The mainly unchanged HbA1c values over the course exclude at least a serious aggravation of the metabolic control. However, it is unclear whether our findings indicate an improvement in glycemic control.
The main limitation of the present evaluation and indeed of almost all studies relating to the German DMP are its purely descriptive nature and the absence of a suitable control group and so the missing comparability of DMP diabetes and standard care regarding their effectiveness. This might lead to a selection bias towards more motivated and healthier patients participating in a DMP. Additionally, systematic differences may exist between those GPs participating in the program and those who, for a variety of reasons, do not take part. On the other hand, the participation of over 580,000 patients provides an almost unrivalled data source with which to evaluate the quality of care within DMP. This enables us to conclude with some certainty that the first 12 years of DMP in Bavaria have seen ongoing improvement in pharmacotherapy and guidelines adherence, hence also an overall improvement in treatment process for patients with diabetes mellitus type 2.
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Conclusion
Summarizing all results leads to the suggestion that the German DMP for type 2 diabetes has been effective in enhancing the quality of care in regard to an improved pharmacotherapy and patient education and therefore to an improved adherence to guidelines. However, no appreciable improvement was observed with regard to smoking status, obesity or HbA1c control.
Authors’ contributions
MM, ED, FB and AS designed the study. ED and FB performed the analysis. MM and ED wrote the initial version of the manuscript. MM, ED, FB, CW and AS revised the manuscript. All authors read and approved the final manuscript.
Acknowledgements
None.
Competing interests
The authors declare that they have no competing interests.
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Availability of data and materials
Due to very strict data security are no data available.
Consent for publication
All authors read and approved the final manuscript.
Ethics approval
The study was approved by the Medical Ethics Committee of the University Hospital Klinikum rechts der Isar, Technische Universität München, Munich.
Publisher’s Note
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