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

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT00268775

Acronym / sponsor ID

WOK/WINAp/CZ-01

Conditions

Benzodiazepines Therapeutic Use

Keywords

community pharmacy services, patient care, outcome assessment, benzodiazepines therapeutic use

Study type

Interventional

Recruitment status

Completed

Enrolment

20,000 participants

Lead sponsor

Radboud University Medical CenterUniversity, hospital or other

Collaborators

Zorgverzekeraar CZ, Scientific Institute for Dutch Pharmacists, The Netherlands

Study start

Nov 2005

Primary completion

Dec 2006 (actual)

Study completion

Dec 2006 (actual)

First posted

22 Dec 2005 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation

Randomised

Intervention model

Single group

Masking

None (open label)

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. percentage of general practitioners that reviewed and returned the list of longterm users.

2. percentage of letters sent by the pharmacists in the four months after receiving the manual.

3. 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
• Background: PubMed 9090699Odedina 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.
• Background: PubMed 8625021Anderson GM, Lexchin J. Strategies for improving prescribing practice. CMAJ. 1996 Apr 1;154(7):1013-7.
• Background: PubMed 11583120Grimshaw 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.
• Background: PubMed 9327814Collins 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.
• Background: PubMed 14584231Muijrers 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.
• Background: PubMed 11282810Zitman 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.
• Background: PubMed 12757968Vorma 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.
• Background: PubMed 12777340Voshaar 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.
• Background: PubMed 12117625Couvee 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.
• Background: PubMed 15951127Mol 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.
• Background: PubMed 14754783Morin 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.
• Background: PubMed 12850904McGregor 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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