Achim Siegel

Shared decision-making in antihypertensive therapy: a cluster randomised controlled trial

BackgroundHypertension 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.MethodsThe 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).ResultsIn 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.ConclusionThe 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 registrationGerman Clinical Trials Register (DRKS): DRKS00000125

Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT

BackgroundHypertension 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/DesignIn 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.DiscussionThe 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 registrationWHO International Clinical Trials: http://apps.who.int/trialsearch/Trial.aspx?TrialID=DRKS00000125

Utilization Dynamics of an Integrated Care System in Germany: Morbidity, Age, and Sex Distribution of Gesundes Kinzigtal Integrated Care’s Membership in 2006–2008

‘Gesundes Kinzigtal Integrated Care’ (GKIC) is one of the few population-based integrated care systems in Germany. By coordinating health care utilization for a defined population in the Kinzigtal region in southwest Germany, GKIC strives to increase the quality of the local health care system and to curb rising health care costs in the region. GKIC explicitly refrains from preferably selecting the traditional “good risks.” Instead, GKIC has adopted an elaborate contractual framework that incentivizes GKIC providers to enroll rather high-risk and high-morbidity insurants. These incentives are designed to induce GKIC and the associated health care providers to first and foremost recruit older people and insurants with an above-average morbidity or morbidity risk into the integrated care network.

DECADE-pilot: decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases—a protocol of a randomized controlled pilot trial

BackgroundA healthy lifestyle can reduce cardiovascular risk (CVR) and prevent premature death. Usually most patients at increased CVR have difficulties implementing the necessary health behavior changes, such as smoking cessation, increasing of physical activity, healthy diet, stress reduction, etc. In this pilot study, a new intervention (DECADE) that includes a cardiovascular risk calculation, evidence-based decision aids, action planning, and follow-up support for patients to reduce their 10-year risk of cardiovascular diseases will be tested in primary care. The objectives of this trial are to test (1) the feasibility of the study design in preparation for the main trail including (2) the usability and acceptance of DECADE, and (3) initial data to ascertain that changes can be observed in these patients.MethodsThis randomized controlled pilot trial will generate initial data on the potential effects of DECADE on patients’ self-evaluated activity and behavior change as well as on clinical outcomes such as blood pressure, cholesterol, body mass index (BMI), HbA1C, and CVR score. In the qualitative part of the study, we will analyze data collected in semi-structured interviews with participating general practitioners (GP) and in patient questionnaires.DiscussionThe outcomes of this pilot study will indicate whether DECADE is a promising intervention in the domain of patient-centered prevention of cardiovascular diseases (CVD) and whether a larger multi-center randomized controlled trial is feasible.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00010584