Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy
The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for establishing and - if necessary - improving adherence to antihypertensive medication in patients with medication-resistant hypertension.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Implementation of a Pharmacy-Intervention to Establish and if Necessary Improve Adherence to Antihypertensive Therapy. A Cluster Randomized Trial.|
- the number of patients included for intervention [ Time Frame: 9 months after start of the study ] [ Designated as safety issue: No ]
- improvement of systolic blood pressure [ Time Frame: 2 and 5 months after inclusion ] [ Designated as safety issue: No ]
- treatment escalation of patients after inclusion into the study [ Time Frame: 5 months after inclusion ] [ Designated as safety issue: No ]
- the percentage of GP's in PTAM that cooperates in the intervention [ Time Frame: 9 months after start of the study ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Other: extensive implementation programme
experimental pharmacists follow an extensive implementation programme. They attend two interactive half a day educational meetings tailored to individual needs: one at start of the intervention, and one in May or September 2007. Special attention is given to multiprofessional cooperation with general practitioners and nurse practitioners. Additionally, guided by their own project planning pharmacists receive three or more telephone calls, both as a reminder, feedback, and in order to investigate whether they need any more help.
|Active Comparator: min||
pharmacists only receive a written manual with instructions to implement the patient compliance intervention.
Cardiovascular disease is the main cause of death in large parts of the world. Hypertension is an important risk factor for cardiovascular disease. Although hypertension treatment has improved in the last decade, the effectiveness of antihypertensive therapy still needs attention. Adherence to medication appears to play an important role in that.
Pharmacists can support the general practitioners in their efforts to optimize antihypertensive therapy, by establishing adherence to medication of patients with hypertension in spite of the use of one or more antihypertensive drugs. This is performed with the electronic Medication Event Monitoring System (MEMS®). Registered adherence and accompanying blood pressure are discussed with the patient by the GP.
Implementation of the above-mentioned intervention is studied in two randomized groups of pharmacies. One group receives minimal support in the intervention, the other group also receives interactive educational meetings, reminders and feedback, and support of multiprofessional cooperation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460343
|Principal Investigator:||Peter G de Smet, PhD||Radboud University|
|Study Director:||Michel Wensing, PhD||Scientific Institute for Quality of Healthcare|