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

NCT ID: NCT00268775

Last Updated: 2009-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Benzodiazepines Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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training and follow-up of pharmacists

Intervention Type BEHAVIORAL

patient-directed discontinuation letter

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zorgverzekeraar CZ

OTHER

Sponsor Role collaborator

Scientific Institute for Dutch Pharmacists, The Netherlands

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Peter G de Smet, PhD

Role: PRINCIPAL_INVESTIGATOR

Scientific Institute for Dutch Pharmacists, The Netherlands

Michel Wensing, PhD

Role: STUDY_DIRECTOR

Centre for Quality of Care Research Nijmegen

Locations

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Apotheek Schellekens

's-Hertogenbosch, , Netherlands

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Apotheek Cleij

's-Hertogenbosch, , Netherlands

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Apotheek Empel

's-Hertogenbosch, , Netherlands

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Apotheek Asten

Asten, , Netherlands

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Apotheek Bakel-Milheeze

Bakel, , Netherlands

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Kring-apotheek Bergeyk

Bergeijk, , Netherlands

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Apotheek Berlicum

Berlicum, , Netherlands

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Lloyds Apotheek van Kollenburg

Best, , Netherlands

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Apotheek de Schakel

Best, , Netherlands

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Apotheek Heivelden

Best, , Netherlands

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Apotheek Blanckenburgh

Beuningen, , Netherlands

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Apotheek Bladel

Bladel, , Netherlands

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Apotheek Bocholtz

Bocholtz, , Netherlands

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Apotheek van de Wouw

Brunssum, , Netherlands

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Apotheek Budel

Budel, , Netherlands

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Apotheek in 't Groen

Deurne, , Netherlands

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Apotheek Koolen-Motké

Deurne, , Netherlands

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Apotheek de Schelde

Deurne, , Netherlands

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Apotheek Druten

Druten, , Netherlands

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Apotheek de Kempen

Eersel, , Netherlands

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Apotheek Elsloo

Elsloo, , Netherlands

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Apotheek Ewijk

Ewijk, , Netherlands

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Apotheek Eygelshoven

Eygelshoven, , Netherlands

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Lloyds Apotheek Geldrop

Geldrop, , Netherlands

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Apotheek het Frans Brugske

Gemert, , Netherlands

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Apotheek Lindner

Gemert, , Netherlands

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Apotheek de Duivenakker

Gennep, , Netherlands

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Apotheek Gennep

Gennep, , Netherlands

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Apotheek de Pijlers

Goes, , Netherlands

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Zeeuwse Apotheek

Goes, , Netherlands

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Apotheek de Goese Polder

Goes, , Netherlands

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Apotheek Groesbeek

Groesbeek, , Netherlands

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Linde apotheek

Hapert, , Netherlands

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Apotheek Heeswijk-Dinther

Heeswijk-Dinther, , Netherlands

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Apotheek Tendijck

Helmond, , Netherlands

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Service Apotheek de Bus

Helmond, , Netherlands

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Service apotheek Vondellaan

Helmond, , Netherlands

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Apotheek de Luifel

Helmond, , Netherlands

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Apotheek Brouwhuis

Helmond, , Netherlands

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Kring-apotheek de Rijpel

Helmond, , Netherlands

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Lloyds Apotheek Herkenbosch

Herkenbosch, , Netherlands

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Apotheek Hegtermans

Herten, , Netherlands

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Apotheek Herten-Merum

Herten, , Netherlands

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apotheek Kerkrade-centrum

Kerkrade, , Netherlands

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Apotheek Schonefeld

Kerkrade, , Netherlands

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Apotheek Bleijerheide

Kerkrade, , Netherlands

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Apotheek Medische Centrum West Kerkrade

Kerkrade, , Netherlands

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Apotheek Terwinselen

Kerkrade, , Netherlands

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Apotheek Waubach

Landgraaf, , Netherlands

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Apotheek Landgraaf

Landgraaf, , Netherlands

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Apotheek MC Putstraat

Landgraaf, , Netherlands

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Apotheek Schaesberg

Landgraaf, , Netherlands

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Apotheek Nieuwenhagen

Landgraaf, , Netherlands

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Apotheek Maarheeze

Maarheeze, , Netherlands

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Apotheek Craveld

Maasbracht, , Netherlands

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Apotheek Maasbracht

Maasbracht, , Netherlands

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Service apotheek Malden

Malden, , Netherlands

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Apotheek Maasdorpen

Meerlo, , Netherlands

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Lloyds Apotheek de Roerstreek

Melick, , Netherlands

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Apotheek Ringeling

Middelburg, , Netherlands

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Apotheek Hummelen

Middelburg, , Netherlands

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Apotheek Stromenwijk 't Zand

Middelburg, , Netherlands

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Apotheek Welsinge

Middelburg, , Netherlands

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Apotheek Dauwendaele

Middelburg, , Netherlands

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Apotheek van der Ploeg

Nijmegen, , Netherlands

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Kring-apotheek Beckers

Nijmegen, , Netherlands

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Apotheek Souburg

Oost-Souburg, , Netherlands

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Lloyds Apotheek Postert

Posterholt, , Netherlands

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Apotheek Reusel

Reusel, , Netherlands

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Lloyds Apotheek Clemens-Haan

Roermond, , Netherlands

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Reinald apotheek

Roermond, , Netherlands

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Apotheek Hendrickx-Maasniel

Roermond, , Netherlands

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Lloyds Apotheek Donderberg

Roermond, , Netherlands

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Apotheek Roermond Zuid

Roermond, , Netherlands

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Apotheek Rosmalen-Walschot

Rosmalen, , Netherlands

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Apotheek Rosmalen

Rosmalen, , Netherlands

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apotheek Simpelveld-Bocholtz

Simpelveld, , Netherlands

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Apotheek Hopveld

Sint-Michielsgestel, , Netherlands

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Apotheek de Baandert

Sittard, , Netherlands

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Wandelbos Apotheek

Tilburg, , Netherlands

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Apotheek de Belleman

Valkenswaard, , Netherlands

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Apotheek Valkenswaard

Valkenswaard, , Netherlands

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Apotheek Vlaslant

Valkenswaard, , Netherlands

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Apotheek Dommeldal

Valkenswaard, , Netherlands

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apotheek 't Zuid

Veghel, , Netherlands

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Veldhovense Apotheek

Veldhoven, , Netherlands

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Apotheek Zonderwijk

Veldhoven, , Netherlands

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Apotheek van Poppel

Wijchen, , Netherlands

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Apotheek Dr. H. Kilian

Wijchen, , Netherlands

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Apotheek Wijchen-Zuid

Wijchen, , Netherlands

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Countries

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Netherlands

References

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Odedina FT, Hepler CD, Segal R, Miller D. The Pharmacists' Implementation of Pharmaceutical Care (PIPC) model. Pharm Res. 1997 Feb;14(2):135-44. doi: 10.1023/a:1012032223328.

Reference Type BACKGROUND
PMID: 9090699 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8625021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11583120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9327814 (View on PubMed)

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. doi: 10.1023/a:1025872907411.

Reference Type BACKGROUND
PMID: 14584231 (View on PubMed)

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. doi: 10.1192/bjp.178.4.317.

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PMID: 11282810 (View on PubMed)

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. doi: 10.1016/s0376-8716(03)00014-0.

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PMID: 12757968 (View on PubMed)

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. doi: 10.1192/bjp.182.6.498.

Reference Type BACKGROUND
PMID: 12777340 (View on PubMed)

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. doi: 10.1016/s0165-0327(01)00330-5.

Reference Type BACKGROUND
PMID: 12117625 (View on PubMed)

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. doi: 10.1016/j.addbeh.2005.04.024. Epub 2005 Jun 13.

Reference Type BACKGROUND
PMID: 15951127 (View on PubMed)

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. doi: 10.1176/appi.ajp.161.2.332.

Reference Type BACKGROUND
PMID: 14754783 (View on PubMed)

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. doi: 10.1080/09595230100100615.

Reference Type BACKGROUND
PMID: 12850904 (View on PubMed)

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. doi: 10.1016/j.drugalcdep.2004.09.001.

Reference Type BACKGROUND
PMID: 15769557 (View on PubMed)

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. Dutch.

Reference Type BACKGROUND
PMID: 11484431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8312045 (View on PubMed)

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. doi: 10.1016/j.drugalcdep.2008.07.009. Epub 2008 Sep 17.

Reference Type DERIVED
PMID: 18801626 (View on PubMed)

Other Identifiers

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WOK/WINAp/CZ-01

Identifier Type: -

Identifier Source: org_study_id

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