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

This study has been completed.
Sponsor:
Collaborators:
Zorgverzekeraar CZ
Scientific Institute for Dutch Pharmacists, The Netherlands
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00509717
First received: February 28, 2007
Last updated: July 9, 2008
Last verified: July 2008
  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
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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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 20, 2014