NCT00268775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

90 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

1.1 years

First QC Date

December 21, 2005

Last Update Submit

August 17, 2009

Conditions

Keywords

community pharmacy servicespatient careoutcome assessmentbenzodiazepines therapeutic use

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • evaluation of the implementation strategies

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (90)

Apotheek Schellekens

's-Hertogenbosch, 5212 NC, Netherlands

Location

Apotheek Cleij

's-Hertogenbosch, 5213 VG, Netherlands

Location

Apotheek Empel

's-Hertogenbosch, 5236 AC, Netherlands

Location

Apotheek Asten

Asten, 5721 EZ, Netherlands

Location

Apotheek Bakel-Milheeze

Bakel, 5761 BN, Netherlands

Location

Kring-apotheek Bergeyk

Bergeijk, 5571 HE, Netherlands

Location

Apotheek Berlicum

Berlicum, 5258 AW, Netherlands

Location

Lloyds Apotheek van Kollenburg

Best, 5683 AE, Netherlands

Location

Apotheek de Schakel

Best, 5684 ER, Netherlands

Location

Apotheek Heivelden

Best, 5685 HS, Netherlands

Location

Apotheek Blanckenburgh

Beuningen, 6641 DD, Netherlands

Location

Apotheek Bladel

Bladel, 5531 CV, Netherlands

Location

Apotheek Bocholtz

Bocholtz, 6351 ES, Netherlands

Location

Apotheek van de Wouw

Brunssum, 6441 CD, Netherlands

Location

Apotheek Budel

Budel, 6021 HT, Netherlands

Location

Apotheek in 't Groen

Deurne, 5751 BG, Netherlands

Location

Apotheek Koolen-Motké

Deurne, 5751 CB, Netherlands

Location

Apotheek de Schelde

Deurne, 5751 VH, Netherlands

Location

Apotheek Druten

Druten, 6651 DE, Netherlands

Location

Apotheek de Kempen

Eersel, 5521 CA, Netherlands

Location

Apotheek Elsloo

Elsloo, 6181 AS, Netherlands

Location

Apotheek Ewijk

Ewijk, 6644 BR, Netherlands

Location

Apotheek Eygelshoven

Eygelshoven, 6471 JH, Netherlands

Location

Lloyds Apotheek Geldrop

Geldrop, 5664 GG, Netherlands

Location

Apotheek het Frans Brugske

Gemert, 5421 HN, Netherlands

Location

Apotheek Lindner

Gemert, 5421 KW, Netherlands

Location

Apotheek de Duivenakker

Gennep, 6591 CZ, Netherlands

Location

Apotheek Gennep

Gennep, 6591 CZ, Netherlands

Location

Apotheek de Pijlers

Goes, 4461 LT, Netherlands

Location

Zeeuwse Apotheek

Goes, 4462 DZ, Netherlands

Location

Apotheek de Goese Polder

Goes, 4463 VA, Netherlands

Location

Apotheek Groesbeek

Groesbeek, 6562 AH, Netherlands

Location

Linde apotheek

Hapert, 5527 BN, Netherlands

Location

Apotheek Heeswijk-Dinther

Heeswijk-Dinther, 5473 GB, Netherlands

Location

Apotheek Tendijck

Helmond, 5701 HN, Netherlands

Location

Service Apotheek de Bus

Helmond, 5702 HW, Netherlands

Location

Service apotheek Vondellaan

Helmond, 5702 HW, Netherlands

Location

Apotheek de Luifel

Helmond, 5703 GA, Netherlands

Location

Apotheek Brouwhuis

Helmond, 5704 LK, Netherlands

Location

Kring-apotheek de Rijpel

Helmond, 5709 BT, Netherlands

Location

Lloyds Apotheek Herkenbosch

Herkenbosch, 6075 AG, Netherlands

Location

Apotheek Hegtermans

Herten, 6049 BS, Netherlands

Location

Apotheek Herten-Merum

Herten, 6049 ES, Netherlands

Location

apotheek Kerkrade-centrum

Kerkrade, 6461 AL, Netherlands

Location

Apotheek Schonefeld

Kerkrade, 6461 EP, Netherlands

Location

Apotheek Bleijerheide

Kerkrade, 6462 AL, Netherlands

Location

Apotheek Medische Centrum West Kerkrade

Kerkrade, 6466 BR, Netherlands

Location

Apotheek Terwinselen

Kerkrade, 6467 GC, Netherlands

Location

Apotheek Waubach

Landgraaf, 6370 JA, Netherlands

Location

Apotheek Landgraaf

Landgraaf, 6371 BM, Netherlands

Location

Apotheek MC Putstraat

Landgraaf, 6372 BK, Netherlands

Location

Apotheek Schaesberg

Landgraaf, 6372 CN, Netherlands

Location

Apotheek Nieuwenhagen

Landgraaf, 6373 KK, Netherlands

Location

Apotheek Maarheeze

Maarheeze, 6026 ER, Netherlands

Location

Apotheek Craveld

Maasbracht, 6050 AD, Netherlands

Location

Apotheek Maasbracht

Maasbracht, 6050 AD, Netherlands

Location

Service apotheek Malden

Malden, 6581 BG, Netherlands

Location

Apotheek Maasdorpen

Meerlo, 5864 AG, Netherlands

Location

Lloyds Apotheek de Roerstreek

Melick, 6074 AP, Netherlands

Location

Apotheek Ringeling

Middelburg, 4331 AM, Netherlands

Location

Apotheek Hummelen

Middelburg, 4331 LL, Netherlands

Location

Apotheek Stromenwijk 't Zand

Middelburg, 4335 GT, Netherlands

Location

Apotheek Welsinge

Middelburg, 4336 ED, Netherlands

Location

Apotheek Dauwendaele

Middelburg, 4337 JH, Netherlands

Location

Apotheek van der Ploeg

Nijmegen, 6522 CA, Netherlands

Location

Kring-apotheek Beckers

Nijmegen, 6524 DL, Netherlands

Location

Apotheek Souburg

Oost-Souburg, 4388 CC, Netherlands

Location

Lloyds Apotheek Postert

Posterholt, 6061 EG, Netherlands

Location

Apotheek Reusel

Reusel, 5541 CS, Netherlands

Location

Lloyds Apotheek Clemens-Haan

Roermond, 6041 HS, Netherlands

Location

Reinald apotheek

Roermond, 6041 XB, Netherlands

Location

Apotheek Hendrickx-Maasniel

Roermond, 6042 JL, Netherlands

Location

Lloyds Apotheek Donderberg

Roermond, 6043 JR, Netherlands

Location

Apotheek Roermond Zuid

Roermond, 6045 GC, Netherlands

Location

Apotheek Rosmalen-Walschot

Rosmalen, 5241 BL, Netherlands

Location

Apotheek Rosmalen

Rosmalen, 5242 HT, Netherlands

Location

apotheek Simpelveld-Bocholtz

Simpelveld, 6369 VP, Netherlands

Location

Apotheek Hopveld

Sint-Michielsgestel, 5271 XP, Netherlands

Location

Apotheek de Baandert

Sittard, 6136 KE, Netherlands

Location

Wandelbos Apotheek

Tilburg, 5044 PB, Netherlands

Location

Apotheek de Belleman

Valkenswaard, 5551 EW, Netherlands

Location

Apotheek Valkenswaard

Valkenswaard, 5554 CA, Netherlands

Location

Apotheek Vlaslant

Valkenswaard, 5554 HA, Netherlands

Location

Apotheek Dommeldal

Valkenswaard, 5554 RM, Netherlands

Location

apotheek 't Zuid

Veghel, 5463 CP, Netherlands

Location

Veldhovense Apotheek

Veldhoven, 5503 BP, Netherlands

Location

Apotheek Zonderwijk

Veldhoven, 5505 AJ, Netherlands

Location

Apotheek van Poppel

Wijchen, 6601 ZX, Netherlands

Location

Apotheek Dr. H. Kilian

Wijchen, 6602 DB, Netherlands

Location

Apotheek Wijchen-Zuid

Wijchen, 6605 HN, Netherlands

Location

Related Publications (16)

  • 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.

    PMID: 9090699BACKGROUND
  • Anderson GM, Lexchin J. Strategies for improving prescribing practice. CMAJ. 1996 Apr 1;154(7):1013-7.

    PMID: 8625021BACKGROUND
  • 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.

    PMID: 11583120BACKGROUND
  • 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.

    PMID: 9327814BACKGROUND
  • 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.

    PMID: 14584231BACKGROUND
  • 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.

    PMID: 11282810BACKGROUND
  • 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.

    PMID: 12757968BACKGROUND
  • 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.

    PMID: 12777340BACKGROUND
  • 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.

    PMID: 12117625BACKGROUND
  • 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.

    PMID: 15951127BACKGROUND
  • 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.

    PMID: 14754783BACKGROUND
  • 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.

    PMID: 12850904BACKGROUND
  • 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.

    PMID: 15769557BACKGROUND
  • 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.

    PMID: 11484431BACKGROUND
  • 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.

    PMID: 8312045BACKGROUND
  • 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.

Study Officials

  • Peter G de Smet, PhD

    Scientific Institute for Dutch Pharmacists, The Netherlands

    PRINCIPAL INVESTIGATOR
  • Michel Wensing, PhD

    Centre for Quality of Care Research Nijmegen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

November 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations