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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00268775
Other study ID # WOK/WINAp/CZ-01
Secondary ID
Status Completed
Phase N/A
First received December 21, 2005
Last updated August 17, 2009
Start date November 2005
Est. completion date December 2006

Study information

Verified date August 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 20000
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
training and follow-up of pharmacists

patient-directed discontinuation letter


Locations

Country Name City State
Netherlands Apotheek Asten Asten
Netherlands Apotheek Bakel-Milheeze Bakel
Netherlands Kring-apotheek Bergeyk Bergeyk
Netherlands Apotheek Berlicum Berlicum
Netherlands Apotheek de Schakel Best
Netherlands Apotheek Heivelden Best
Netherlands Lloyds Apotheek van Kollenburg Best
Netherlands Apotheek Blanckenburgh Beuningen
Netherlands Apotheek Bladel Bladel
Netherlands Apotheek Bocholtz Bocholtz
Netherlands Apotheek van de Wouw Brunssum
Netherlands Apotheek Budel Budel
Netherlands Apotheek Cleij Den Bosch
Netherlands Apotheek Empel Den Bosch
Netherlands Apotheek Schellekens Den Bosch
Netherlands Apotheek de Schelde Deurne
Netherlands Apotheek in 't Groen Deurne
Netherlands Apotheek Koolen-Motké Deurne
Netherlands Apotheek Druten Druten
Netherlands Apotheek de Kempen Eersel
Netherlands Apotheek Elsloo Elsloo
Netherlands Apotheek Ewijk Ewijk
Netherlands Apotheek Eygelshoven Eygelshoven
Netherlands Lloyds Apotheek Geldrop Geldrop
Netherlands Apotheek het Frans Brugske Gemert
Netherlands Apotheek Lindner Gemert
Netherlands Apotheek de Duivenakker Gennep
Netherlands Apotheek Gennep Gennep
Netherlands Apotheek de Goese Polder Goes
Netherlands Apotheek de Pijlers Goes
Netherlands Zeeuwse Apotheek Goes
Netherlands Apotheek Groesbeek Groesbeek
Netherlands Linde apotheek Hapert
Netherlands Apotheek Heeswijk-Dinther Heeswijk-Dinther
Netherlands Apotheek Brouwhuis Helmond
Netherlands Apotheek de Luifel Helmond
Netherlands Apotheek Tendijck Helmond
Netherlands Kring-apotheek de Rijpel Helmond
Netherlands Service Apotheek de Bus Helmond
Netherlands Service apotheek Vondellaan Helmond
Netherlands Lloyds Apotheek Herkenbosch Herkenbosch
Netherlands Apotheek Hegtermans Herten
Netherlands Apotheek Herten-Merum Herten
Netherlands Apotheek Bleijerheide Kerkrade
Netherlands apotheek Kerkrade-centrum Kerkrade
Netherlands Apotheek Medische Centrum West Kerkrade Kerkrade
Netherlands Apotheek Schonefeld Kerkrade
Netherlands Apotheek Terwinselen Kerkrade
Netherlands Apotheek Landgraaf Landgraaf
Netherlands Apotheek MC Putstraat Landgraaf
Netherlands Apotheek Nieuwenhagen Landgraaf
Netherlands Apotheek Schaesberg Landgraaf
Netherlands Apotheek Waubach Landgraaf
Netherlands Apotheek Maarheeze Maarheeze
Netherlands Apotheek Craveld Maasbracht
Netherlands Apotheek Maasbracht Maasbracht
Netherlands Service apotheek Malden Malden
Netherlands Apotheek Maasdorpen Meerlo
Netherlands Lloyds Apotheek de Roerstreek Melick
Netherlands Apotheek Dauwendaele Middelburg
Netherlands Apotheek Hummelen Middelburg
Netherlands Apotheek Ringeling Middelburg
Netherlands Apotheek Stromenwijk 't Zand Middelburg
Netherlands Apotheek Welsinge Middelburg
Netherlands Apotheek van der Ploeg Nijmegen
Netherlands Kring-apotheek Beckers Nijmegen
Netherlands Apotheek Souburg Oost-Souburg
Netherlands Lloyds Apotheek Postert Posterholt
Netherlands Apotheek Reusel Reusel
Netherlands Apotheek Hendrickx-Maasniel Roermond
Netherlands Apotheek Roermond Zuid Roermond
Netherlands Lloyds Apotheek Clemens-Haan Roermond
Netherlands Lloyds Apotheek Donderberg Roermond
Netherlands Reinald apotheek Roermond
Netherlands Apotheek Rosmalen Rosmalen
Netherlands Apotheek Rosmalen-Walschot Rosmalen
Netherlands apotheek Simpelveld-Bocholtz Simpelveld
Netherlands Apotheek Hopveld Sint Michielsgestel
Netherlands Apotheek de Baandert Sittard
Netherlands Wandelbos Apotheek Tilburg
Netherlands Apotheek de Belleman Valkenswaard
Netherlands Apotheek Dommeldal Valkenswaard
Netherlands Apotheek Valkenswaard Valkenswaard
Netherlands Apotheek Vlaslant Valkenswaard
Netherlands apotheek 't Zuid Veghel
Netherlands Apotheek Zonderwijk Veldhoven
Netherlands Veldhovense Apotheek Veldhoven
Netherlands Apotheek Dr. H. Kilian Wijchen
Netherlands Apotheek van Poppel Wijchen
Netherlands Apotheek Wijchen-Zuid Wijchen

Sponsors (3)

Lead Sponsor Collaborator
Radboud University Scientific Institute for Dutch Pharmacists, The Netherlands, Zorgverzekeraar CZ

Country where clinical trial is conducted

Netherlands, 

References & Publications (15)

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

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. — View Citation

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. — View Citation

Couvée 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mol AJ, Oude 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. 2006 Feb;31(2):211-22. Epub 2005 Jun 13. — View Citation

Morin CM, Bastien C, Guay B, Radouco-Thomas M, Leblanc J, Vallières 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. — View Citation

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. — View Citation

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

Oude Voshaar RC, Gorgels WJ, Mol AJ, Couvée 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. — View Citation

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. — View Citation

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. — View Citation

Zitman FG, Couvée 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of general practitioners that reviewed and returned the list of longterm users.
Primary percentage of letters sent by the pharmacists in the four months after receiving the manual.
Primary 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 evaluation of the implementation strategies