Implementation Strategies for a Simple Intervention to Reduce Longterm Benzodiazepine Use in Dutch Community Pharmacies - Full Text View

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:

Click here for more information about this study: Implementation strategies aimed at patient-directed interventions in Dutch community pharmacies This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Odedina FT, Hepler CD, Segal R, Miller D. The Pharmacists' Implementation of Pharmaceutical Care (PIPC) model. Pharm Res. 1997 Feb;14(2):135-44.

Anderson GM, Lexchin J. Strategies for improving prescribing practice. CMAJ. 1996 Apr 1;154(7):1013-7. Review.

Grimshaw JM, Shirran L, Thomas R, Mowatt G, Fraser C, Bero L, Grilli R, Harvey E, Oxman A, O'Brien MA. Changing provider behavior: an overview of systematic reviews of interventions. Med Care. 2001 Aug;39(8 Suppl 2):II2-45.

Collins TM, Mott DA, Bigelow WE, Zimmerman DR. A controlled letter intervention to change prescribing behavior: results of a dual-targeted approach. Health Serv Res. 1997 Oct;32(4):471-89.

Muijrers PE, Knottnerus JA, Sijbrandij J, Janknegt R, Grol RP. Changing relationships: attitudes and opinions of general practitioners and pharmacists regarding the role of the community pharmacist. Pharm World Sci. 2003 Oct;25(5):235-41.

Zitman FG, Couvee JE. Chronic benzodiazepine use in general practice patients with depression: an evaluation of controlled treatment and taper-off: report on behalf of the Dutch Chronic Benzodiazepine Working Group. Br J Psychiatry. 2001 Apr;178:317-24.

Vorma H, Naukkarinen H, Sarna S, Kuoppasalmi K. Long-term outcome after benzodiazepine withdrawal treatment in subjects with complicated dependence. Drug Alcohol Depend. 2003 Jun 5;70(3):309-14.

Voshaar RC, Gorgels WJ, Mol AJ, van Balkom AJ, van de Lisdonk EH, Breteler MH, van den Hoogen HJ, Zitman FG. Tapering off long-term benzodiazepine use with or without group cognitive-behavioural therapy: three-condition, randomised controlled trial. Br J Psychiatry. 2003 Jun;182:498-504.

Couvee JE, Timmermans MA, Zitman FG; Dutch Chronic Benzodiazepine Working Group. The long-term outcome of a benzodiazepine discontinuation programme in depressed outpatients. J Affect Disord. 2002 Jul;70(2):133-41.

Mol AJ, Voshaar RC, Gorgels WJ, Breteler MH, van Balkom AJ, van de Lisdonk EH, Kan CC, Mulder J, Zitman FG. The absence of benzodiazepine craving in a general practice benzodiazepine discontinuation trial. Addict Behav. 2005 Jun 10; [Epub ahead of print]

Morin CM, Bastien C, Guay B, Radouco-Thomas M, Leblanc J, Vallieres A. Randomized clinical trial of supervised tapering and cognitive behavior therapy to facilitate benzodiazepine discontinuation in older adults with chronic insomnia. Am J Psychiatry. 2004 Feb;161(2):332-42.

McGregor C, Machin A, White JM. In-patient benzodiazepine withdrawal: comparison of fixed and symptom-triggered taper methods. Drug Alcohol Rev. 2003 Jun;22(2):175-80.

Gorgels WJ, Oude Voshaar RC, Mol AJ, van de Lisdonk EH, van Balkom AJ, van den Hoogen HJ, Mulder J, Breteler MH, Zitman FG. Discontinuation of long-term benzodiazepine use by sending a letter to users in family practice: a prospective controlled intervention study. Drug Alcohol Depend. 2005 Apr 4;78(1):49-56.

Oude Voshaar RC, Gorgels WJ, Mol AJ, Couvee JE, van Balkom AJ, Zitman FG. [Treatment methods for discontinuation of long-term benzodiazepine use] Ned Tijdschr Geneeskd. 2001 Jul 14;145(28):1347-50. Review. Dutch.

Cormack MA, Sweeney KG, Hughes-Jones H, Foot GA. Evaluation of an easy, cost-effective strategy for cutting benzodiazepine use in general practice. Br J Gen Pract. 1994 Jan;44(378):5-8.

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 a discontinuation letter to reduce long-term benzodiazepine use--a cluster randomized trial. Drug Alcohol Depend. 2009 Jan 1;99(1-3):105-14. Epub 2008 Sep 17.

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 May 23, 2013