Summary
Background
Uncontrolled hypertension is a major primary healthcare problem.
Aim
To investigate whether blood pressure (BP) control in primary care could be improved by nurses taking responsibility for managing hypertensive patients.
Methods
Randomized trial with two groups: usual or intensive care. Patients diagnosed previously as hypertensive and with a systolic office BP greater than 140 mmHg were randomized to an intensive care programme managed by trained nurses or to usual care. The intensive care programme included a visit every 6 weeks to the general practitioner’s office, with standardized BP measurement, self-measurement training, risk factor checks and advice on BP reduction. The intervention lasted for 1 year. The primary endpoints were systolic BP obtained by 24-hour ambulatory BP monitoring after 1 year and the change compared with baseline.
Results
Two hundred patients from 19 physicians were enrolled (102 in the intensive care group). Data on ambulatory BP were available from 140 patients. Systolic BP declined from 134.4 ± 14.0 to 126.3 ± 10.4 mmHg in the intensive care group and from 132.4 ± 13.5 to 128.2 ± 13.0 mmHg in the usual care group. There was no statistically significant difference in values after 1 year ( p = 0.332). The reduction in systolic BP was significantly greater in the intensive care group (7.6 vs 3.3 mmHg in the usual care group; p = 0.036). Similar results were observed for diastolic BP and day- and night-time measurements.
Conclusions
An intensive medical care programme in the office setting managed by trained nurses can improve BP control effectively. Nurses could take more responsibility for managing hypertensive patients.
Résumé
Justification
L’hypertension artérielle non contrôlée est un problème majeur de santé publique.
Objectifs
Nous avons investigué l’hypothèse qu’un meilleur contrôle de la pression artérielle par des infirmières spécialisées en éducation thérapeutique pouvait améliorer la prise en charge des patients hypertendus.
Méthode
Cette étude randomisée comprenait deux groupes, traitement habituel et traitement intensif de l’hypertension artérielle. Les patients ayant un antécédent d’hypertension artérielle et une pression artérielle systolique en consultation supérieure à 140 mmHg ont été randomisés entre les deux bras, programme intensif et traitement habituel. Le programme intensif était assuré par des infirmières spécialisées et incluait une visite toutes les six semaines au cabinet du médecin généraliste, avec des mesures standards de la pression artérielle, une information et une prise en main de l’automesure, le contrôle de plusieurs facteurs de risque et des conseils sur les modalités de baisse de la pression artérielle. L’étude a duré un an au minimum. Le critère de jugement principal était la détermination de la pression artérielle systolique déterminée par pression artérielle ambulatoire, sur 24 heures, après un an de prise en charge, comparativement aux valeurs à l’état basal.
Résultats
Deux cents patients traités par 19 médecins ont été inclus dans l’étude, dont 102 dans le bras traitement intensif. Les données sur la pression artérielle ambulatoire étaient disponibles pour 140 patients. La pression artérielle systolique a diminué de 134,4 ± 14,0 à 126,3 ± 10,4 mmHg dans le groupe traitement intensif et de 132,4 ± 13,5 à 128,2 ± 13,0 mmHg dans le bras traitement usuel. Il n’y avait pas de différence statistiquement significative pour les valeurs mesurées à un an ( p = 0,332). La diminution de la pression artérielle systolique était significativement plus importante dans le groupe traitement intensif, comparativement au groupe traitement usuel (7,6 vs 3,3 mmHg ; p = 0,036). Des résultats similaires ont été observés pour la pression artérielle diastolique, ainsi que pour les mesures de pression artérielle en période nocturne.
Conclusion
Un programme intensif d’éducation thérapeutique assuré par des infirmières spécialisées peut améliorer le contrôle de la pression artérielle chez des patients hypertendus. Les infirmières pourraient prendre plus de responsabilités dans la prise en charge et le traitement des patients hypertendus.
Abreviations
ABPM
ambulatory blood pressure monitoring
BP
blood pressure
GP
general practitioner
Introduction
Hypertension is a major risk factor for cardiovascular and cerebrovascular diseases and a leading cause of mortality worldwide . Lowering blood pressure (BP) with medication and/or lifestyle modifications can reduce substantially the subsequent risks of morbidity and mortality from stroke, heart failure, renal disease and other diseases . However, surveys in many countries show that only a portion of patients with hypertension have BP that is within designated levels . A recent survey in the USA and five European countries showed that BP control is best in the USA (63%), whereas in Europe the rates are between 31% and 46% . Therefore, there is much room for further improvement in BP control. It is time for action on BP control as stated in a recent editorial . A cross-sectional survey with general practitioners (GPs) showed that BP less than 140/90 mmHg was achieved in only 42% of patients .
Several factors are correlated with inadequate control of elevated BP , a key, one of which is therapeutic inertia . Many studies have been published investigating the ability of various programmes to increase adherence to medication and change lifestyle factors. BP measurement at home, education programmes and nurse management of hypertensive patients have the potential to improve adherence to medication and to increase willingness to modify lifestyle factors .
Fahey et al. published a review on the effects of various interventions , and concluded that a system of regular follow-up should be organized and that the appropriate drug and dosage should be used when patients do not reach the target BP level.
It may well be that strategies have to be individualized to be fully effective . Improving adherence to medication and modification of lifestyle factors are still challenges for physicians and other healthcare providers . The time constraints placed on today’s primary care physician work force may be one factor that contributes to low control of BP .
The aim of this intervention study was to investigate whether the implementation of an intensive medical education programme managed by trained nurses could increase BP control. The intervention combined several methods that have been investigated in different studies: self-monitoring of BP, patient education, nurse management and frequent appointments. The intention was to investigate the effect of this programme, which can be adopted easily into routine practice. Hence we did not implement any monitoring to measure drug adherence, although this method can improve BP control . The integration of nurses into the management of hypertensive patients seems to be a valuable tool in itself . However, the effect on ambulatory BP has not been investigated.
Methods
Patients with a prior diagnosis of hypertension and a systolic office BP greater than 140 mmHg were eligible for the study. The participants’ systolic and diastolic BP were measured by a trained nurse in the physician’s office using a standard protocol and standardized validated automated devices. After a 5-minute rest, seated BP measurements were repeated three times at 2-minute intervals. The third measurement was used as the reference value for study inclusion.
After giving informed consent, all patients received a device for measuring BP at home (Stabil-0-Graph ) and were randomized using sealed envelopes to the intensive care programme or to the control group with usual care.
Usual care involved routine visits to the GP’s office at least every 6 months, unless there was a specific reason for an earlier visit. All patients in the intensive care programme received a booklet on hypertension and were invited to visit the GP’s office at least every 6 weeks for their BP to be measured and to receive individualized advice on how to change lifestyle factors and comply with the prescribed medication. The intervention lasted 1 year and was conducted by nurses trained intensively by one of the authors (MM).
The study was performed in Upper Bavaria in Germany and was approved by the Ethical Committee of the Medical Association of Bavaria.
Primary endpoint
The main outcome was systolic BP assessed by 24-hour ambulatory BP monitoring (ABPM; Mobil O Graph ) after 1 year, as well as the change compared with baseline. We used the 24-hour measurements, which are considered to be the gold standard of BP measurement in diagnosis and treatment.
Secondary endpoints
Secondary endpoints were systolic ambulatory BP during the daytime (07:00–22:00) and night-time (22:00–07:00), diastolic ambulatory BP, office BP and change in lifestyle factors (weight, physical activity, tobacco smoking and alcohol consumption).
All variables were measured at baseline and after 1 year. Office BP and lifestyle factors were also recorded after 6 months.
Statistical methods
The data are described as means and standard deviations or numbers and percentages. The primary endpoint (the difference in the change in systolic BP between groups) was analysed by the t -test. The differences within groups were compared by the paired t -test. All other continuous data were analysed in the same way. Qualitative data were compared with the Chi 2 test (between groups) or McNemar’s test (within groups). A p -value of 0.05 was considered significant. All analyses were performed with SPSS statistical software, version 15.0.
Sample size calculation
A decline in the office measurement of systolic BP of 10 mmHg corresponds to a change in 24-hour systolic BP of about 7 mmHg . The reduction in the incidence of stroke achieved by a decline in systolic BP of 10 mmHg (office measurement) will be around 35–40%. Our aim was to achieve this reduction in the intervention group. We also expected a reduction in systolic BP in the usual care group of about 3 mmHg, as the result of participation in a study. The trial was designed to have a power of 80% to detect a difference in 24-hour systolic BP between groups of at least 4 mmHg, with a standard deviation of 10 mmHg. This leads to n = 78 patients per group. To allow for dropouts, we aimed to enrol about 100 patients per group into the study.
Results
Study population
A total of 19 physicians agreed to participate in this study. Between May 2005 and October 2006, 200 patients were enrolled, 102 into the intensive care group and 98 into the usual care group. The physicians recruited between one and 47 patients. The mean age was approximately 65 years. About half of the patients were men. The mean body mass index was between 29 and 30 kg/m 2 , indicating that nearly 50% of patients were obese. About 65% of patients reported that they drank alcohol, and 61.8% in the intensive care group and 70.4% in the usual care group were non-smokers. Physical activity amounted to around 4 hours per person per week. Thirty-four patients had diabetes (21 in the intensive care group; 13 in the usual care group) and 13 patients had a history of myocardial infarction. Other comorbidities were reported rarely. There were no significant differences between the groups ( Table 1 ).
| Intensive care group ( n = 102) | Usual care group ( n = 98) | p value | |
|---|---|---|---|
| Age (years) | 65.8 ± 8.9 | 65.1 ± 8.5 | 0.70 |
| Weight (kg) | 82.6 ± 15.0 | 84.2 ± 15.9 | 0.62 |
| Body mass index (kg/m 2 ) | 29.0 ± 5.2 | 29.9 ± 5.1 | 0.13 |
| Physical activity (hours/week) | 4.8 ± 6.8 | 3.6 ± 4.4 | 0.14 |
| Female sex | 42 (41.2) | 51 (52.0) | 0.12 |
| Smoking status | 0.53 | ||
| Non-smoker | 63 (61.8) | 69 (70.4) | |
| Ex-smoker | 18 (17.6) | 16 (16.3) | |
| Current smoker | 15 (14.7) | 9 (9.2) | |
| Alcohol intake | 0.56 | ||
| No information | 2 (2.0) | 3 (3.1) | |
| No alcohol | 30 (29.4) | 36 (36.7) | |
| < 1 drink/day | 49 (48.0) | 38 (38.8) | |
| ≥ 1 drink/day | 21 (20.6) | 21 (21.4) | |
| Comorbidities | |||
| Diabetes | 21 (20.6) | 13 (13.3) | |
| Myocardial infarction/CHD | 6 (5.9) | 7 (7.1) | |
| Peripheral | 3 (2.9) | 1 (1.0) | |
| Obstructive arterial disease | |||
| Stroke | 2 (2.0) | 2 (2.0) | |
| Chronic obstructive | 3 (2.9) | 4 (4.1) | |
| Pulmonary disease |
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