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1.  Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial 
BMC Family Practice  2013;14:135.
Background
Hypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs.
Methods
The study was conducted as a cluster randomised controlled trial (cRCT) with GP practices in Southwest Germany. Each GP practice included patients with treated but uncontrolled hypertension and/or with relevant comorbidity. After baseline assessment (T0) GP practices were randomly allocated into an intervention and a control arm. GPs of the intervention group took part in the SDM training. GPs of the control group treated their patients as usual. The intervention was blinded to the patients. Primary endpoints on patient level were (1) change of patients’ perceived participation (SDM-Q-9) and (2) change of systolic BP (24h-mean). Secondary endpoints were changes of (1) diastolic BP (24h-mean), (2) patients’ knowledge about hypertension, (3) adherence (MARS-D), and (4) cardiovascular risk score (CVR).
Results
In total 1357 patients from 36 general practices were screened for blood pressure control by ambulatory blood pressure monitoring (ABPM). Thereof 1120 patients remained in the study because of uncontrolled (but treated) hypertension and/or a relevant comorbidity. At T0 the intervention group involved 17 GP practices with 552 patients and the control group 19 GP practices with 568 patients. The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints.
Conclusion
The study hypothesis that the SDM training enhanced patients’ perceived participation and lowered their BP could not be confirmed. Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care.
Trial registration
German Clinical Trials Register (DRKS): DRKS00000125
doi:10.1186/1471-2296-14-135
PMCID: PMC3847233  PMID: 24024587
Hypertension; Shared decision-making; Ambulatory blood pressure monitoring; Educational training; Primary care; Family medicine; Cluster randomised controlled trial
2.  Converting habits of antibiotic prescribing for respiratory tract infections in German primary care – the cluster-randomized controlled CHANGE-2 trial 
BMC Family Practice  2012;13:124.
Background
With an average prescription rate of 50%, in German primary care antibiotics are still too frequently prescribed for respiratory tract infections. The over-prescription of antibiotics is often explained by perceived patient pressure and fears of a complicated disease progression. The CHANGE-2 trial will test the effectiveness of two interventions to reduce the rate of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infections in German primary care.
Methods/Design
The study is a three-arm cluster-randomized controlled trial that measures antibiotic prescription rates over three successive winter periods and reverts to administrative data of the German statutory health insurance company AOK. More than 30,000 patients in two regions of Germany, who visit their general practitioner or pediatrician for respiratory tract infections will be included. Interventions are: A) communication training for general practitioners and pediatricians and B) intervention A plus point-of-care testing. Both interventions are tested against usual care. Outcome measure is the physicians’ antibiotic prescription rate for respiratory tract infections derived from data of the health insurance company AOK. Secondary outcomes include reconsultation rate, complications, and hospital admissions.
Discussion
Major aim of the study is to improve the process of decision-making and to ensure that patients who are likely to benefit from antibiotics are treated accordingly. Our approach is simple to implement and might be used rapidly among general practitioners and pediatricians. We expect the results of this trial to have major impact on antibiotic prescription strategies and practices in Germany, both among general practitioners and pediatricians.
Trial registration
The study is registered at the Current Controlled Trials Ltd (ISRCTN01559032)
doi:10.1186/1471-2296-13-124
PMCID: PMC3548682  PMID: 23256712
Antibiotic prescribing; Respiratory tract infections; Primary care; Randomized controlled trial
3.  Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT 
Background
Hypertension is one of the key factors causing cardiovascular diseases which make up the most frequent cause of death in industrialised nations. However about 60% of hypertensive patients in Germany treated with antihypertensives do not reach the recommended target blood pressure. The involvement of patients in medical decision making fulfils not only an ethical imperative but, furthermore, has the potential of higher treatment success. One concept to enhance the active role of patients is shared decision making. Until now there exists little information on the effects of shared decision making trainings for general practitioners on patient participation and on lowering blood pressure in hypertensive patients.
Methods/Design
In a cluster-randomised controlled trial 1800 patients receiving antihypertensives will be screened with 24 h ambulatory blood pressure monitoring in their general practitioners’ practices. Only patients who have not reached their blood pressure target (approximately 1200) will remain in the study (T1 – T3). General practitioners of the intervention group will take part in a shared decision making-training after baseline assessment (T0). General practitioners of the control group will treat their patients as usual. Primary endpoints are change of systolic blood pressure and change of patients’ perceived participation. Secondary endpoints are changes of diastolic blood pressure, knowledge, medical adherence and cardiovascular risk. Data analysis will be performed with mixed effects models.
Discussion
The hypothesis underlying this study is that shared decision making, realised by a shared decision making training for general practitioners, activates patients, facilitates patients’ empowerment and contributes to a better hypertension control. This study is the first one that tests this hypothesis with a (cluster-) randomised trial and a large sample size.
Trial registration
WHO International Clinical Trials: http://apps.who.int/trialsearch/Trial.aspx?TrialID=DRKS00000125
doi:10.1186/1471-2261-12-73
PMCID: PMC3467178  PMID: 22966894
Arterial hypertension; Cardiovascular diseases; Cardiovascular risk; Shared decision making; Educational training; Blood pressure control; Ambulatory blood pressure monitoring; Adherence; Primary care; Family medicine
4.  Does integrated care lead to both improved service quality and lower care cost 
Purpose and context
‘Gesundes Kinzigtal’ is one of the few population-based integrated care approaches in Germany, organising care across all health service sectors and indications. The management company and its contracting partners (the physicians’ network in the region and two statutory health insurers) strive to reach a higher quality of care at a lower overall cost as compared with the German standard. During its first two years of operation (2006–2007), the Kinzigtal project achieved surprisingly positive financial results compared with its reference value. To gain independent evidence on the quality aspects of the system, the management company and its partners provided a remarkable budget for its evaluation by independent scientific institutions.
Case description and data sources
We will present interim results of a population-based controlled cohort study. In this study, quality of care is checked by relying on health and service quality indicators that have been constructed from health insurers’ administrative data (claims data). Interim results are presented for the intervention region (Kinzigtal area) and the control region (the rest of Baden-Württemberg, i.e., Southwest Germany).
Preliminary conclusions and discussion
The evaluation of ‘Gesundes Kinzigtal’ is in full progress. Until now, there is no evidence that the surprisingly positive financial results of the Kinzigtal system have been achieved at the expense of care quality. Rather, Gesundes Kinzigtal Integrated Care seems to be about to increasingly realize comparative advantages regarding health service quality (in comparison to the control region).
PMCID: PMC3031841
Gesundes Kinzigtal Integrated Care; quality of care indicators; cost of care/health services; population-based integrated care
5.  Inverted risk selection—a structural property of a new population-based integrated care system in Germany 
Background and purpose
In the Kinzigtal region in Southwest Germany, a population-based integrative care system has been set up in 2005–2006, organising care across all health service sectors and indications. The system is run by a regional health management company (Gesundes Kinzigtal GmbH) in cooperation with the physicians' network in the region and with two statutory health insurers (among them is the biggest health insurer in Southwest Germany: AOK Baden-Württemberg). Membership is optional for insured persons in the Kinzigtal area. In contrast to many other Managed Care organisations, Gesundes Kinzigtal and its partners have intentionally attempted to prevent a policy of risk selection and to organize a better (integrated) care first of all for the so-called ‘bad risks’ such as older persons and the chronically ill. To determine whether that attempt has been successful, we analyse the administrative data of the concerned health insurers during the building phase of the Kinzigtal system (2006–2008).
Theory
A common critique of Managed Care initiatives holds that while economic and financial goals have come to dominate, a strategy of risk selection—i.e. preferred recruitment of the young and/or healthy—has often been forwarded. To overcome this experience, Gesundes Kinzigtal and its partners have set up a specific system of contractual and financial incentives to realize a kind of inverted risk selection, implying the preferred recruitment of the so-called ‘bad risks’. In the contribution we outline the contractual and economic incentives which are to produce an inverted risk selection and a more efficient care in greater detail.
Methods
To check whether Gesundes Kinzigtal has managed to realize an inverted risk selection, age, social status and morbidity costs of the insured members of the integrated care network are compared with the data of those assureds in the Kinzigtal region who have not (yet) become members. The contribution will focus on the health insurers' administrative data that were collected during the whole building phase of the system (2006–2008).
Results and conclusions
The available data show that the Kinzigtal integrated care system has indeed managed to realize an inverted risk selection during its building phase (2006–2008), i.e. its members are considerably older and cause remarkably higher morbidity costs than the non-members in that area.
Discussion
The contractual and financial incentives of the Kinzigtal system have obviously been adequate means to realize an inverted risk selection. At the same time, the financial results of the first two years (2006–2007) of the system have turned out surprisingly positive (see other abstract)—thus Gesundes Kinzigtal demonstrates the huge potential of population-based integrated care approaches.
PMCID: PMC2807106
Germany; integrated care system; risk selection
6.  Lower health care cost by superior (integrated) care management? Evaluation of a population-based integrated care system in Germany—first results 
Purpose and context
‘Gesundes Kinzigtal’ is one of the few population-based integrated care approaches in Germany, organising care across all health service sectors and indications. The system is run by a regional health management company (Gesundes Kinzigtal GmbH) in cooperation with the regional physicians' network and with two statutory health insurers (among them is the biggest health insurer in Southwest Germany: AOK Baden-Württemberg). Membership is optional for insured persons in the Kinzigtal area. The management company and its partners maintain to reach a higher quality of organisational, coordination and interaction processes (among the concerned physicians, therapists, pharmacists, hospitals, patients and health insurers) at a lower overall cost as compared with the German standard. During its first two years of operation (2006–2007), the Kinzigtal project actually achieved positive financial results as compared with its reference value. To gain independent evidence on the quality aspects of the system, the management company and the two cooperating health insurers provided a remarkable budget for the evaluation of the system by independent scientific institutions. Since 2006–2007 several evaluation projects have started, investigating different quality aspects of the Kinzigtal system. In our presentation we will outline the overall evaluation concept and report some preliminary results.
Case description and data sources
Preliminary results of the following studies will be presented. A controlled cohort study, beginning in 2007, investigates the assureds' attitudes towards quality of care, shared-decision-making and overall patient satisfaction both in the Kinzigtal region as well as in a control region. In a second controlled cohort study the quality of care is checked by relying on health insurers' administrative data which are routinely collected on all reimbursed health care services. A third study, pursuing a simple cohort study design, investigates the attitudes of the cooperating physicians, physiotherapists, psychotherapists as well as pharmacists.
Preliminary conclusions and discussion
The evaluation of the integrated care system in the Kinzigtal area in Germany is still in progress. Up until now, there is no evidence that the positive financial results of the Kinzigtal system have been achieved at the expense of the quality of care. If these results were confirmed at the time of study completion (or if an even improved quality of care in the Kinzigtal region were demonstrated), the Kinzigtal integrated care system could become a role model for many other similar regions in Germany and Europe.
PMCID: PMC2807105
Germany; integrated care system
7.  Management principles and financial results of a population-based integrative care approach in Germany 
Purpose and context
‘Gesundes Kinzigtal’ is one of the few population-based integrative care approaches in Germany, organising care across all health service sectors and indications. The system is run by a regional health management company (Gesundes Kinzigtal GmbH) in cooperation with the physicians' network in the region and with two statutory health insurers (among them is the biggest health insurer in Southwest Germany: AOK Baden-Württemberg). Membership is optional for insured persons in the Kinzigtal area. The management company and its partners strive for a higher organisational quality (as concerns management and interaction processes among the cooperating physicians, physiotherapists, pharmacists, hospitals, patients and health insurers) at lower overall cost as compared with the German standard. Very recently first financial results of the Kinzigtal system during its first two years of operation have been presented—they are surprisingly positive. This contribution will discuss which principles of inter-professional cooperation and which management strategies have proven to be effective and thus have probably led to these results.
Case description and data sources
In our presentation, we will describe the principles of strategic management of the integrated care system. Among these are
– the construction process of the management company itself, comprising both medical/therapeutic expertise by physicians and other health professions and management expertise,
– the development and prioritization of integrated health programmes,
– the structure of economic incentives, and
– the cooperation between management company and health insurers.
The financial results of the Kinzigtal integrated care system are measured in the context of a shared-savings contract. The calculation model resembles health insurers' calculation of the contribution margin difference of a given population. The calculation model will be described in greater detail during the presentation, as well as the actual financial results of 2006 and 2007.
Conclusions and discussion
The management and cooperation principles which have been implemented in the Kinzigtal integrated care system seem to have led to a higher efficiency in the organisation of population health services—obviously without losses in quality of care and at lower overall cost compared to the German standard. In our presentation, the Kinzigtal experience will be related to similar projects in Germany and other European countries. If the success of the Kinzigtal model should prove to be sustainable during the years to come, it could even become an example for other similar regions in Germany and Europe.
PMCID: PMC2807087
Germany; management; finances; integrated care systems

Results 1-7 (7)