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

Implementation Strategies Aimed at a Simple Patient-directed Intervention to Reduce Long-term Use of Benzodiazepines in Dutch Community Pharmacies

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.

Study Overview

• Status: Completed
• Conditions: Benzodiazepines Therapeutic Use
• Intervention / Treatment: Behavioral: training and follow-up of pharmacists; Behavioral: patient-directed discontinuation letter

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
• Enrollment: 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Asten, Netherlands, 5721 EZ
    • Apotheek Asten
  • Bakel, Netherlands, 5761 BN
    • Apotheek Bakel-Milheeze
  • Bergeyk, Netherlands, 5571 HE
    • Kring-apotheek Bergeyk
  • Berlicum, Netherlands, 5258 AW
    • Apotheek Berlicum
  • Best, Netherlands, 5683 AE
    • Lloyds Apotheek van Kollenburg
  • Best, Netherlands, 5684 ER
    • Apotheek de Schakel
  • Best, Netherlands, 5685 HS
    • Apotheek Heivelden
  • Beuningen, Netherlands, 6641 DD
    • Apotheek Blanckenburgh
  • Bladel, Netherlands, 5531 CV
    • Apotheek Bladel
  • Bocholtz, Netherlands, 6351 ES
    • Apotheek Bocholtz
  • Brunssum, Netherlands, 6441 CD
    • Apotheek van de Wouw
  • Budel, Netherlands, 6021 HT
    • Apotheek Budel
  • Den Bosch, Netherlands, 5212 NC
    • Apotheek Schellekens
  • Den Bosch, Netherlands, 5213 VG
    • Apotheek Cleij
  • Den Bosch, Netherlands, 5236 AC
    • Apotheek Empel
  • Deurne, Netherlands, 5751 BG
    • Apotheek in 't Groen
  • Deurne, Netherlands, 5751 CB
    • Apotheek Koolen-Motké
  • Deurne, Netherlands, 5751 VH
    • Apotheek de Schelde
  • Druten, Netherlands, 6651 DE
    • Apotheek Druten
  • Eersel, Netherlands, 5521 CA
    • Apotheek de Kempen
  • Elsloo, Netherlands, 6181 AS
    • Apotheek Elsloo
  • Ewijk, Netherlands, 6644 BR
    • Apotheek Ewijk
  • Eygelshoven, Netherlands, 6471 JH
    • Apotheek Eygelshoven
  • Geldrop, Netherlands, 5664 GG
    • Lloyds Apotheek Geldrop
  • Gemert, Netherlands, 5421 HN
    • Apotheek het Frans Brugske
  • Gemert, Netherlands, 5421 KW
    • Apotheek Lindner
  • Gennep, Netherlands, 6591 CZ
    • Apotheek de Duivenakker
  • Gennep, Netherlands, 6591 CZ
    • Apotheek Gennep
  • Goes, Netherlands, 4461 LT
    • Apotheek de Pijlers
  • Goes, Netherlands, 4462 DZ
    • Zeeuwse Apotheek
  • Goes, Netherlands, 4463 VA
    • Apotheek de Goese Polder
  • Groesbeek, Netherlands, 6562 AH
    • Apotheek Groesbeek
  • Hapert, Netherlands, 5527 BN
    • Linde apotheek
  • Heeswijk-Dinther, Netherlands, 5473 GB
    • Apotheek Heeswijk-Dinther
  • Helmond, Netherlands, 5701 HN
    • Apotheek Tendijck
  • Helmond, Netherlands, 5702 HW
    • Service Apotheek de Bus
  • Helmond, Netherlands, 5702 HW
    • Service apotheek Vondellaan
  • Helmond, Netherlands, 5703 GA
    • Apotheek de Luifel
  • Helmond, Netherlands, 5704 LK
    • Apotheek Brouwhuis
  • Helmond, Netherlands, 5709 BT
    • Kring-apotheek de Rijpel
  • Herkenbosch, Netherlands, 6075 AG
    • Lloyds Apotheek Herkenbosch
  • Herten, Netherlands, 6049 BS
    • Apotheek Hegtermans
  • Herten, Netherlands, 6049 ES
    • Apotheek Herten-Merum
  • Kerkrade, Netherlands, 6461 AL
    • apotheek Kerkrade-centrum
  • Kerkrade, Netherlands, 6461 EP
    • Apotheek Schonefeld
  • Kerkrade, Netherlands, 6462 AL
    • Apotheek Bleijerheide
  • Kerkrade, Netherlands, 6466 BR
    • Apotheek Medische Centrum West Kerkrade
  • Kerkrade, Netherlands, 6467 GC
    • Apotheek Terwinselen
  • Landgraaf, Netherlands, 6370 JA
    • Apotheek Waubach
  • Landgraaf, Netherlands, 6371 BM
    • Apotheek Landgraaf
  • Landgraaf, Netherlands, 6372 BK
    • Apotheek MC Putstraat
  • Landgraaf, Netherlands, 6372 CN
    • Apotheek Schaesberg
  • Landgraaf, Netherlands, 6373 KK
    • Apotheek Nieuwenhagen
  • Maarheeze, Netherlands, 6026 ER
    • Apotheek Maarheeze
  • Maasbracht, Netherlands, 6050 AD
    • Apotheek Craveld
  • Maasbracht, Netherlands, 6050 AD
    • Apotheek Maasbracht
  • Malden, Netherlands, 6581 BG
    • Service apotheek Malden
  • Meerlo, Netherlands, 5864 AG
    • Apotheek Maasdorpen
  • Melick, Netherlands, 6074 AP
    • Lloyds Apotheek de Roerstreek
  • Middelburg, Netherlands, 4331 AM
    • Apotheek Ringeling
  • Middelburg, Netherlands, 4331 LL
    • Apotheek Hummelen
  • Middelburg, Netherlands, 4335 GT
    • Apotheek Stromenwijk 't Zand
  • Middelburg, Netherlands, 4336 ED
    • Apotheek Welsinge
  • Middelburg, Netherlands, 4337 JH
    • Apotheek Dauwendaele
  • Nijmegen, Netherlands, 6522 CA
    • Apotheek van der Ploeg
  • Nijmegen, Netherlands, 6524 DL
    • Kring-apotheek Beckers
  • Oost-Souburg, Netherlands, 4388 CC
    • Apotheek Souburg
  • Posterholt, Netherlands, 6061 EG
    • Lloyds Apotheek Postert
  • Reusel, Netherlands, 5541 CS
    • Apotheek Reusel
  • Roermond, Netherlands, 6041 HS
    • Lloyds Apotheek Clemens-Haan
  • Roermond, Netherlands, 6041 XB
    • Reinald apotheek
  • Roermond, Netherlands, 6042 JL
    • Apotheek Hendrickx-Maasniel
  • Roermond, Netherlands, 6043 JR
    • Lloyds Apotheek Donderberg
  • Roermond, Netherlands, 6045 GC
    • Apotheek Roermond Zuid
  • Rosmalen, Netherlands, 5241 BL
    • Apotheek Rosmalen-Walschot
  • Rosmalen, Netherlands, 5242 HT
    • Apotheek Rosmalen
  • Simpelveld, Netherlands, 6369 VP
    • apotheek Simpelveld-Bocholtz
  • Sint Michielsgestel, Netherlands, 5271 XP
    • Apotheek Hopveld
  • Sittard, Netherlands, 6136 KE
    • Apotheek de Baandert
  • Tilburg, Netherlands, 5044 PB
    • Wandelbos Apotheek
  • Valkenswaard, Netherlands, 5551 EW
    • Apotheek de Belleman
  • Valkenswaard, Netherlands, 5554 CA
    • Apotheek Valkenswaard
  • Valkenswaard, Netherlands, 5554 HA
    • Apotheek Vlaslant
  • Valkenswaard, Netherlands, 5554 RM
    • Apotheek Dommeldal
  • Veghel, Netherlands, 5463 CP
    • apotheek 't Zuid
  • Veldhoven, Netherlands, 5503 BP
    • Veldhovense Apotheek
  • Veldhoven, Netherlands, 5505 AJ
    • Apotheek Zonderwijk
  • Wijchen, Netherlands, 6601 ZX
    • Apotheek van Poppel
  • Wijchen, Netherlands, 6602 DB
    • Apotheek Dr. H. Kilian
  • Wijchen, Netherlands, 6605 HN
    • Apotheek Wijchen-Zuid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
evaluation of the implementation strategies

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: 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 and helpful links

General Publications

• 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.
• 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.
• Anderson GM, Lexchin J. Strategies for improving prescribing practice. CMAJ. 1996 Apr 1;154(7):1013-7.
• 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. doi: 10.1023/a:1025872907411.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: December 21, 2005
• First Submitted That Met QC Criteria: December 21, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): August 18, 2009
• Last Update Submitted That Met QC Criteria: August 17, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: patient care; outcome assessment; community pharmacy services; benzodiazepines therapeutic use
• Other Study ID Numbers: WOK/WINAp/CZ-01