Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice
1 Collège National des Généralistes Enseignants, 6 bis, rue des Deux Communes, Vincennes, 94300, France
2 Département de Médecine Générale, Faculté de Médecine, Université François Rabelais, 10, boulevard Tonnellé, BP 3223, , Tours Cedex 1, 37032, France
3 Service de Pharmacologie Clinique, Université Claude Bernard, CNRS UMR 5558, rue Guillaume Paradin, BP 8071, Lyon Cedex 08, 69376,, France
4 Département de Médecine Générale, Faculté de Médecine, Université Paris-Est Créteil Val de Marne (UPEC), 8 avenue du Général Sarrail, Créteil Cedex, 94010,, France
5 Service d’Endocrinologie-Métabolisme, Hôpital de la Pitié-Salpêtrière, 45-83 boulevard de l’Hôpital, Paris Cedex 13, 75651,, France
6 Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud. Service de Biostatistiques, CNRS UMR 5558, rue Guillaume Paradin, BP 8071, Lyon Cedex 8, 69376,, France
Trials 2013, 14:318 doi:10.1186/1745-6215-14-318Published: 1 October 2013
Several observational studies on hypertensive patients have shown a gap between therapeutic targets recommended in guidelines and those achieved in daily practice. The ESCAPE trial aimed to determine whether a multifaceted intervention focused on general practitioners (GPs), could increase significantly the proportion of hypertensive patients at high risk in primary prevention who achieved all their recommended therapeutic targets.
A pragmatic, cluster randomized trial involving 257 GPs randomized by region. The GPs in the intervention group had a one-day training session and were given an electronic blood pressure measurement device and a short recommendation leaflet. Along with usual follow-up, they focused one consultation on hypertension and other cardiovascular risk factors every six months for two years. They also received feedback at baseline and at one year on their patients’ clinical and biological parameters. Main outcome measures were change in the proportion of patients achieving all their therapeutic targets and each individual therapeutic target at two years, and quality of life.
1,832 high-risk hypertensive patients were included. After two years, the proportion of patients achieving all their therapeutic targets increased significantly in both groups, but significantly more in the intervention group: OR (odds-ratio) 1.89, (95% confidence interval (CI) 1.09 to 3.27, P = 0.02). Significantly more patients achieved their blood pressure targets in the intervention group than in the usual care group: OR 2.03 (95% CI 1.44 to 2.88, P < 0.0001). Systolic and diastolic blood pressures decreased significantly more in the intervention group than in the usual care group, by 4.8 mmHg and 1.9 mmHg, respectively (P < 0.0001 for both). There were no significant difference changes in physical and mental quality of life between groups.
An easy-to-perform, multifaceted intervention targeting only GPs increased significantly the proportion of high-risk hypertensive patients in primary prevention achieving their recommended therapeutic targets.
This trial was registered with ClinicalTrials.gov, number NCT00348855