ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00268775
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : August 18, 2009
Sponsor:
Collaborators:
Zorgverzekeraar CZ
Scientific Institute for Dutch Pharmacists, The Netherlands
Information provided by:
Radboud University

Brief Summary:
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 or disease Intervention/treatment Phase
Benzodiazepines Therapeutic Use Behavioral: training and follow-up of pharmacists Behavioral: patient-directed discontinuation letter Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Implementation Strategies Aimed at a Simple Patient-directed Intervention to Reduce Long-term Use of Benzodiazepines in Dutch Community Pharmacies
Study Start Date : November 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. percentage of general practitioners that reviewed and returned the list of longterm users.
  2. percentage of letters sent by the pharmacists in the four months after receiving the manual.
  3. 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 :
  1. evaluation of the implementation strategies


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

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
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

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