Increased cardiovascular risk Circulatory System Hypertension
Conditions
Interventions
This is a cluster-randomised controlled two-arm interventional study with an embedded qualitative study. A cluster is composed of the recruited patients of one GP surgery
in group practices, all GP partners are allocated to the same study arm.
Both groups A and B (the control arm) will receive specifically composed information by post, based on current guidelines on c
Sponsors
German Federal Ministry of Education and Research (BMBF) and the Federation of Sickness Fund Boards
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 102 general practitioners will be recruited to participate in the study, and will be randomised into groups A or B. Each GP recruits a consecutive sample of 40 patients meeting the following criteria: 1. Aged 40-75 years 2. Known diagnosis of hypertension for >6 months 3. Life expectancy not <1 year 4. Fluency in the German language The sample for the qualitative part covers 30 general practitioners not belonging to the quantitative study sample within the same region before the study and 15 general practitioners within the RCT-sample after the quantitative study.
Exclusion criteria
Exclusion criteria: Exclusion criteria for GPs are: 1. Less than 500 cases per three months (quarter) 2. Atypical patients or practice Exclusion criteria for patients: see inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 21/07/2008: Primary endpoint is the mean absolute cardiovascular risk (CVR) of the subset of patients with high CVR (but no manifest cardiovascular disease) in each randomisation group (A versus B). The composite endpoint 'cardiovascular risk' is calculated from several risk factors by using a slightly modified version of the SCORE formula published by Conroy et al. (European Heart Journal 2003). Previous primary outcome measures: Primary endpoint is the mean absolute cardiovascular risk (CVR) of the patients in each group. The composed endpoint cardiovascular risk is calculated from the single given risk factors by using a slightly modified version of the SCORE-formula published by Conroy et al. (European Heart Journal 2003). For the qualitative study: adapting existing guideline tools for physicians' compliance. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The intervention's effect on blood pressure, cholesterol levels, smoking rates, and physical exercise in patients with: a. A history of manifested CV disease b. High CVR (defined by SCORE >4%) c. Low CVR (SCORE <5%) 2. The intervention's effect on drug treatment, judged by current guidelines, in patients with: a. A history of manifested CV disease b. High CVR c. Low CVR 3. A possible relationship of CVR with: a. Patient gender b. Patients' socioeconomic status c. The quality of the doctor-patient-relationship 4. The intervention's effect on: a. The accuracy with which doctors and patients estimate individual CVR b. The degree to which the patient is being involved in the decision making process | — |
Countries
Germany
Outcome results
None listed