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

Purpose

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.

Condition	Intervention
Cardiovascular Diseases	Other: intensive implementation programme Other: control

Study Type:	Interventional
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 Enhance Prescription and Use of Lipid-Lowering Drugs. A Randomized Trial.

Further study details as provided by Radboud University:

Primary Outcome Measures:

The percentage of selected (=undertreated) patients receiving at least one prescription for lipid-lowering medication. [ Time Frame: six months after the general practitioner received the list with selected patients ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Differences in prescribing for age categories and co-medication. [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	October 2006
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: experimental	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.
Active Comparator: control	Other: control educational manual

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509717

Locations

Netherlands
UMC St Radboud, Scientific Institute for Quality of Healthcare
Nijmegen, NL, Netherlands, 6500 HB

Sponsors and Collaborators

Radboud University

Zorgverzekeraar CZ

Scientific Institute for Dutch Pharmacists, The Netherlands

Investigators

Principal Investigator:	Peter G. de Smet, PhD	Radboud University
Study Director:	Michel Wensing, PhD	Scientific Institute for Quality of Healthcare

More Information

Publications:

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.

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.

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.

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. Summary for patients in: Curr Cardiol Rep. 2002 Nov;4(6):486-7.

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

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Van de Steeg-van Gompel CH, Wensing M, De Smet PA. Implementation of patient education at first and second dispensing of statins in Dutch community pharmacies: the sequel of a cluster randomized trial. BMC Health Serv Res. 2011 Nov 16;11:313.

Responsible Party:	Caroline van de Steeg-van Gompel, Scientific Institute for Quality of Healthcare
ClinicalTrials.gov Identifier:	NCT00509717 History of Changes
Other Study ID Numbers:	WOK/WINAp/CZ-02
Study First Received:	February 28, 2007
Last Updated:	July 9, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

quality of health care
prescriptions, drug
anticholesteremic agents
community pharmacy services

Additional relevant MeSH terms:

Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013