Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension.

BACKGROUND: Adherence to medication and lifestyle interventions are essential keys for the management of hypertension. In this respect, a structured educational program for hypertensive patients has got remarkable merits (herz.leben). In order to determine the isolated effect of participation in the educational program, neglecting the possible impact of more intense care, this prospective multicenter randomized controlled study was designed (NCT00453037). METHODS: A total of 256 patients in 13 centers were enrolled and randomly assigned to 2 groups (G). G-I (n = 137) underwent the educational program immediately (T-0), G-II (n = 119) after 6 months (T-6). Follow-up visits were done after 6 (T-6) and 12 (T-12) months. Primary endpoint was a difference in office blood pressure (BP) at T-6, when only G-I had undergone the educational program. RESULTS: Patients' baseline characteristics were comparable. At T-6, systolic office and home BP were significantly lower in G-I compared to G-II: office BP systolic 139 (134-150) mm Hg vs. 150 (135-165) mm Hg (P < 0.01); diastolic 80 (76-85) mm Hg vs. 84 (75-90) mm Hg (ns); home BP systolic 133 (130-140) mm Hg vs. 142 (132-150) mm Hg (P < 0.01); diastolic 80 (75-85) mm Hg vs. 80 (76-89) mm Hg (ns)). At T-12, when all patients had undergone the educational program differences in BP disappeared. CONCLUSION: The results of this multicenter randomized controlled study provide significant evidence for benefit by participation in a structured educational program. Positive effects seem to be mediated by better adherence and life style changes due to higher levels of information and patient empowerment. Therefore, educational strategies should be considered as standard of care for hypertensive patients.

Effects of a multifaceted educational program on blood pressure and cardiovascular risk in hypertensive patients: the Austrian herz.leben project.

OBJECTIVE: Although hypertension is the most prevalent risk factor for cardiovascular and cerebrovascular morbidity and mortality, the level of blood pressure control remains poor. To amplify quality of care in hypertensive patients, a multifaceted program consisting of structured educational programs for both patients and staff, structured documentation and feedback reports with peer comparison, was implemented on a multicentre basis. Main targets were improvement of blood pressure control and reduction of cardiovascular risk. A provisional reimbursement was provided. METHODS: Patients were eligible for inclusion in the program if office blood pressure was uncontrolled (>160/95 or >140/90 mmHg) in addition to elevated cardiovascular risk [>15% according to the New Zealand Risk Score (NZRS)]. Blood pressure and lipid panels were measured at entry in the program and after 12 months. Patients attended four educational units held by hypertension nurses and physicians. All data were collected in structured documentation sheets and benchmarking reports were provided every 6 months. RESULTS: Two thousand and forty-one patients were enrolled in the program within 5 years and 3 months; 54% female, age 62.8 ±â€Š11.1years, BMI 29.50 ±â€Š7.88 kg/m (mean ±â€ŠSD). To date, 744 patients have been seen at 1-year follow-up. Entry blood pressure was 156.1 ±â€Š20.8/88.9 ±â€Š11.1 mmHg. Total cholesterol showed mean levels of 207.0 ±â€Š46.0 mg/dl, low-density lipoprotein 122.3 ±â€Š41.6 mg/dl, high-density lipoprotein 57.2 ±â€Š22.4 mg/dl and calculated cardiovascular risk level (NZRS) was 17.28 ±â€Š8.29%. One year following the educational program, blood pressure was reduced to 139.2 ±â€Š15.6 (P < 0.001)/82.1 ±â€Š9.5 mmHg (P < 0.001). NZRS (14.1 ±â€Š7.2%; P < 0.001) and BMI (29.26 ±â€Š4.92 versus 29.06 ±â€Š4.99) also improved significantly. CONCLUSION: This structured educational program showed its ability to improve intermediate outcomes in hypertensive patients. Better blood pressure control and significant reduction of the individual cardiovascular risk profile were achieved. A broad implementation of the program in the management of hypertension seems justified.

Quality of diabetes care in Austrian diabetic patients willing to participate in a DMP - at baseline.

INTRODUCTION: Diabetes mellitus type 2 plays an important role in population health worldwide, and diabetes care has been shown to be insufficient. Disease management programmes (DMPs) have been designed to overcome these deficiencies, but data on their effectiveness are inconclusive. One reason for the inconsistent extent of effects may be selection bias. Voluntary programmes might recruit preferably highly motivated patients who are already quite successful in managing diabetes. Other programmes enrol primarily patients with poor metabolic control which may lead to the demonstration of fairly large effects due to regression to the mean. We therefore investigated the baseline characteristics of patients willing to enrol in the Austrian DMP for diabetes mellitus type 2 ("Therapie aktiv"), and their quality of care. METHODS: We offered the study to all GPs and internists in the province of Salzburg. The physicians were asked to recruit all patients with type 2 diabetes according to WHO/ADA-criteria willing to participate in the Austrian DMP "Therapie aktiv". For all patients, data regarding metabolic control, medication, cardiovascular risk factors and diabetes complications were recorded and then analysed to detect deficiencies in care. RESULTS: One thousand Four hundred and eighty-nine patients (mean age 65.4 ± 10.4 years; 47.8% women) were recruited by 92 physicians. 24.3% of all participants (28.3% of the men and 20.1% of the women) had at least one diabetes-related complication with a significantly higher rate of cardiovascular complications in the male study population. 80.7% of all patients were treated with oral antidiabetics, insulin or both. With regards to quality of care 5% of all patients with an HbA1c above 7.5% did not receive any antidiabetic medication at all. 15.3% of the study population with high blood pressure was not supplied with any antihypertensive medication and 36.6% of the study participants with cardiovascular disease were not treated with a statin. CONCLUSION: Our results indicate that the majority of the patients receive treatment in adherence to current guidelines. Nevertheless there are deficits in care and hence room for improvement by implementation of the DMP.

The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial.

BACKGROUND: Disease management programmes (DMPs) are costly and impose additional work load on general practitioners (GPs). Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. METHODS: All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI), enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. RESULTS: 92 physicians recruited 1489 patients (649 intervention, 840 control). After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT) of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02) was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607). Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043). Additionally, more patients received patient education (49.5% vs. 20.1%, p < 0.0001), eye- (71.0% vs. 51.2%, p < 0.0001), foot examinations (73.8% vs. 45.1%, p < 0.0001), and regular HbA1c checks (44.1% vs. 36.0%, p < 0.01) in the intervention group. CONCLUSION: The Austrian DMP implemented by statutory health insurance improves process quality and enhances weight reduction, but does not significantly improve metabolic control for patients with type 2 diabetes mellitus. Whether the small benefit seen in secondary outcome measures leads to better patient outcomes, remains unclear. TRIAL REGISTRATION: Current Controlled trials Ltd., ISRCTN27414162.

Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial.

BACKGROUND: Due to its rising prevalence type 2 diabetes plays an important role concerning population health in Austria and other western countries. In various studies deficiencies in the care of diabetic patients have been revealed. These deficiencies may be overcome by disease-management-programmes (DMPs), but international experience shows that the effectiveness of DMPs is inconsistent. In particular large programmes designed by state-affiliated public health insurances have not been evaluated in randomized controlled trials (RCTs). We are therefore conducting a large scale RCT of the Austrian DMP for type 2 diabetic patients in the province of Salzburg to evaluate the programme regarding its effects on metabolic control, guideline adherent care and the quality of life of diabetic patients. METHODS/DESIGN: The study is open for participation to all GPs and internists in the province of Salzburg. Physicians are randomized before recruitment of patients with the districts of Salzburg as clusters of randomisation. A total of over 1200 patients with type 2 diabetes will then be recruited. In the intervention group the DMP is applied for one year. Controls receive usual care. Endpoints are a decrease in HbA1c in the intervention group > 0.5% compared to controls, a higher percentage of patients with required diagnostic measures according to guidelines, improved cardiovascular risk profile and higher quality of life scores within one year. CURRENT STATUS OF THE STUDY: 98 Physicians agreed to participate in the study. 96 of them recruited 1494 patients, 654 in the intervention and 840 in the control group. TRIAL REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. (ISRCTN27414162).