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

NCT ID: NCT00509717

Last Updated: 2008-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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experimental

Group Type EXPERIMENTAL

intensive implementation programme

Intervention Type OTHER

educational manual; interactive educational meeting tailored to individual needs; reminders and feedback by 3 newsletters and at least 3 telephone calls.

control

Group Type ACTIVE_COMPARATOR

control

Intervention Type OTHER

educational manual

Interventions

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intensive implementation programme

educational manual; interactive educational meeting tailored to individual needs; reminders and feedback by 3 newsletters and at least 3 telephone calls.

Intervention Type OTHER

control

educational manual

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pharmacies: resident in the south of the Netherlands
* patients: with antiplatelet therapy and without lipid-lowering medication

Exclusion Criteria

* terminal disease
* severe mental disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zorgverzekeraar CZ

OTHER

Sponsor Role collaborator

Scientific Institute for Dutch Pharmacists, The Netherlands

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Scientific Institute for Quality of Healthcare

Principal Investigators

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Peter G. de Smet, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Michel Wensing, PhD

Role: STUDY_DIRECTOR

Scientific Institute for Quality of Healthcare

Locations

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UMC St Radboud, Scientific Institute for Quality of Healthcare

Nijmegen, NL, Netherlands

Site Status

Countries

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Netherlands

References

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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. doi: 10.1111/j.1365-2125.2004.02152.x.

Reference Type BACKGROUND
PMID: 15327591 (View on PubMed)

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. doi: 10.1093/pubmed/fdg030.

Reference Type BACKGROUND
PMID: 12848404 (View on PubMed)

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. doi: 10.3310/hta8060.

Reference Type BACKGROUND
PMID: 14960256 (View on PubMed)

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. doi: 10.1016/S0140-6736(02)09327-3.

Reference Type BACKGROUND
PMID: 12114036 (View on PubMed)

Gaw A. The care gap: underuse of statin therapy in the elderly. Int J Clin Pract. 2004 Aug;58(8):777-85. doi: 10.1111/j.1368-5031.2004.00300.x.

Reference Type BACKGROUND
PMID: 15372851 (View on PubMed)

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. doi: 10.1111/j.1365-2125.2004.02256.x.

Reference Type BACKGROUND
PMID: 15676046 (View on PubMed)

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. doi: 10.1185/030079905X46368.

Reference Type BACKGROUND
PMID: 15969884 (View on PubMed)

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

Reference Type BACKGROUND

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. doi: 10.1007/s11096-005-7112-9.

Reference Type BACKGROUND
PMID: 16341744 (View on PubMed)

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. doi: 10.1186/1472-6963-11-313.

Reference Type DERIVED
PMID: 22087850 (View on PubMed)

Other Identifiers

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WOK/WINAp/CZ-02

Identifier Type: -

Identifier Source: org_study_id