Implementation Strategies for a Simple Intervention to Reduce Longterm Benzodiazepine Use in Dutch Community Pharmacies

This study has been completed.
Sponsor:
Collaborators:
Zorgverzekeraar CZ
Scientific Institute for Dutch Pharmacists, The Netherlands
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00268775
First received: December 21, 2005
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to compare the effect of two implementation strategies for a simple patient-directed intervention to reduce long-term benzodiazepine use in Dutch community pharmacies.


Condition Intervention
Benzodiazepines Therapeutic Use
Behavioral: training and follow-up of pharmacists
Behavioral: patient-directed discontinuation letter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Implementation Strategies Aimed at a Simple Patient-directed Intervention to Reduce Long-term Use of Benzodiazepines in Dutch Community Pharmacies

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • percentage of general practitioners that reviewed and returned the list of longterm users.
  • percentage of letters sent by the pharmacists in the four months after receiving the manual.
  • percentage of long-term benzodiazepine users that managed to quit or significantly reduce their use in months 0-3, 4-6 and 10-12 after receiving the letter.

Secondary Outcome Measures:
  • evaluation of the implementation strategies

Estimated Enrollment: 20000
Study Start Date: November 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

In Dutch community pharmacies many projects have been undertaken in the field of pharmaceutical care, with mixed results. It is not yet clear which elements exactly contribute to the success of these projects and to implementation of pharmaceutical care.

One of the subjects to which attention is paid in community pharmacies, is the undesirable long-term use of benzodiazepines. Treatment methods for discontinuation of long-term benzodiazepine use have been studied rather extensively. A simple patient-directed discontinuation letter proved to be effective in several studies.

Comparison: a minimal intervention group (pharmacists carrying out the intervention guided by a manual only) compared to a maximal intervention group (pharmacists receiving a manual, a training aimed at better cooperation and communication with family practitioners and some support in the management of the project).

  Eligibility

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

Inclusion Criteria:

  • benzodiazepine use for more than 3 months in the last 12 months AND for more than 60 days in the last 2 months

Exclusion Criteria:

  • treatment by psychiatrist, treatment of alcohol- or drug misuse, psychotic episodes in history, epilepsy, terminal disease, not mastering the Dutch language, individual criteria used by the family practitioner
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268775

  Show 90 Study Locations
Sponsors and Collaborators
Radboud University
Zorgverzekeraar CZ
Scientific Institute for Dutch Pharmacists, The Netherlands
Investigators
Principal Investigator: Peter G de Smet, PhD Scientific Institute for Dutch Pharmacists, The Netherlands
Study Director: Michel Wensing, PhD Centre for Quality of Care Research Nijmegen
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00268775     History of Changes
Other Study ID Numbers: WOK/WINAp/CZ-01
Study First Received: December 21, 2005
Last Updated: August 17, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
community pharmacy services
patient care
outcome assessment
benzodiazepines therapeutic use

ClinicalTrials.gov processed this record on April 21, 2014