Clinical trial NCT00460343: Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy
Official title: Implementation of a Pharmacy-Intervention to Establish and if Necessary Improve Adherence to Antihypertensive Therapy. A Cluster Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: patient non-adherence
antihypertensive agents
community pharmacy services
professional roles
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Zorgverzekeraar CZ
name: Scientific Institute for Dutch Pharmacists, The Netherlands
First posted: 2007-04-13
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* pharmacies: resident in the south of the Netherlands
* patients:

  * 18 years or older
  * diagnosis of hypertension
  * systolic blood pressure between 150 and 180 mm Hg despite the use of antihypertensive drug(s)
  * indication for treatment escalation

Exclusion Criteria:

* patients:

  * impossibility to establish blood pressure properly
  * patient treated by medical specialist
  * change of antihypertensive therapy because of adverse effects of current medication
  * insisting on using dose organisers
  * not managing their drug intake themselves
  * not able to come to the pharmacy

Primary outcomes:
measure: the number of patients included for intervention
timeFrame: 9 months after start of the study
Secondary outcomes:
measure: improvement of systolic blood pressure
timeFrame: 2 and 5 months after inclusion
measure: treatment escalation of patients after inclusion into the study
timeFrame: 5 months after inclusion
measure: the percentage of GP's in PTAM that cooperates in the intervention
timeFrame: 9 months after start of the study
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Peter G de Smet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Institute for Quality of Healthcare
name: Michel Wensing, PhD
role: STUDY_DIRECTOR
References:
citation: Ragot S, Sosner P, Bouche G, Guillemain J, Herpin D. Appraisal of the knowledge of hypertensive patients and assessment of the role of the pharmacists in the management of hypertension: results of a regional survey. J Hum Hypertens. 2005 Jul;19(7):577-84. doi: 10.1038/sj.jhh.1001859.
citation: Krousel-Wood M, Thomas S, Muntner P, Morisky D. Medication adherence: a key factor in achieving blood pressure control and good clinical outcomes in hypertensive patients. Curr Opin Cardiol. 2004 Jul;19(4):357-62. doi: 10.1097/01.hco.0000126978.03828.9e.
citation: Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13.
citation: Burnier M, Schneider MP, Chiolero A, Stubi CL, Brunner HR. Electronic compliance monitoring in resistant hypertension: the basis for rational therapeutic decisions. J Hypertens. 2001 Feb;19(2):335-41. doi: 10.1097/00004872-200102000-00022.
citation: Waeber B, Vetter W, Darioli R, Keller U, Brunner HR. Improved blood pressure control by monitoring compliance with antihypertensive therapy. Int J Clin Pract. 1999 Jan-Feb;53(1):37-8.
citation: Carter BL, Zillich AJ, Elliott WJ. How pharmacists can assist physicians with controlling blood pressure. J Clin Hypertens (Greenwich). 2003 Jan-Feb;5(1):31-7. doi: 10.1111/j.1524-6175.2003.01460.x.
citation: Fahey T, Schroeder K, Ebrahim S. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD005182. doi: 10.1002/14651858.CD005182.
citation: Wetzels GE, Nelemans PJ, Schouten JS, Dirksen CD, van der Weijden T, Stoffers HE, Janknegt R, de Leeuw PW, Prins MH. Electronic monitoring of adherence as a tool to improve blood pressure control. A randomized controlled trial. Am J Hypertens. 2007 Feb;20(2):119-25. doi: 10.1016/j.amjhyper.2006.07.018.