Implementation of a Pharmacy-Intervention to Enhance Prescription and Use of Lipid-Lowering Drugs

Cardiovascular Diseases Clinical Trial

Official title:

Implementation of a Pharmacy-Intervention to Enhance Prescription and Use of Lipid-Lowering Drugs. A Randomized Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509717
• Other study ID #: WOK/WINAp/CZ-02
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: July 9, 2008
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: July 2008
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease.

Description:

Cardiovascular disease is the main cause of death in large parts of the world. Next to life style changes, pharmaceutical treatment is a keystone in the treatment of cardiovascular disease. Despite the strong evidence for the effectiveness of lipid-lowering therapy, less than half of the people eligible are treated. With specific medication searches in the community pharmacy database, an easy tool for detecting patients who are undertreated is available. Based on this tool, a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease was constructed.

Moreover, it is not known yet how to implement this pharmaceutical care model in community pharmacies effectively. With multifaceted interventions the behaviour of health professionals can be changed. In this study the effectiveness of a maximal support strategy, including interactive educational meetings, reminders, audit and feedback, is compared to a minimal implementation strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pharmacies: resident in the south of the Netherlands

• patients: with antiplatelet therapy and without lipid-lowering medication

Exclusion Criteria:for patients:

• terminal disease

• severe mental disorder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• intensive implementation programme
educational manual; interactive educational meeting tailored to individual needs; reminders and feedback by 3 newsletters and at least 3 telephone calls.
• control
educational manual

Locations

Country	Name	City	State
Netherlands	UMC St Radboud, Scientific Institute for Quality of Healthcare	Nijmegen	NL

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Scientific Institute for Dutch Pharmacists, The Netherlands, Zorgverzekeraar CZ

Country where clinical trial is conducted

Netherlands, 

References & Publications (9)

Blenkinsopp A, Anderson C, Armstrong M. Systematic review of the effectiveness of community pharmacy-based interventions to reduce risk behaviours and risk factors for coronary heart disease. J Public Health Med. 2003 Jun;25(2):144-53. Review. — View Citation

Gaw A. The care gap: underuse of statin therapy in the elderly. Int J Clin Pract. 2004 Aug;58(8):777-85. Review. — View Citation

Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004 Feb;8(6):iii-iv, 1-72. Review. — View Citation

Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. — View Citation

Mantel-Teeuwisse AK, Verschuren WM, Klungel OH, de Boer A, Kromhout D. Recent trends in (under)treatment of hypercholesterolaemia in the Netherlands. Br J Clin Pharmacol. 2004 Sep;58(3):310-6. — View Citation

Nederlands Huisartsen Genootschap (NHG). NHG-standaard Cardiovasculair Risicomanagement. 2006 Jan.

Stuurman-Bieze AG, de Boer WO, Kokenberg ME, Hugtenburg JG, de Jong-van den Berg LT, Tromp TF. Complex pharmaceutical care intervention in pulmonary care: part A. The process and pharmacists' professional satisfaction. Pharm World Sci. 2005 Oct;27(5):376-84. — View Citation

Teeling M, Bennett K, Feely J. The influence of guidelines on the use of statins: analysis of prescribing trends 1998-2002. Br J Clin Pharmacol. 2005 Feb;59(2):227-32. — View Citation

van Wyk JT, Picelli G, Dieleman JP, Mozaffari E, Kramarz P, van Wijk MA, van der Lei J, Sturkenboom MC. Management of hypertension and hypercholesterolaemia in primary care in The Netherlands. Curr Med Res Opin. 2005 Jun;21(6):839-48. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of selected (=undertreated) patients receiving at least one prescription for lipid-lowering medication.		six months after the general practitioner received the list with selected patients	No
Secondary	Differences in prescribing for age categories and co-medication.		six months	No