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

Study Overview
=================
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.

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).

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

Conditions
-----------------
Benzodiazepines Therapeutic Use

Intervention / Treatment
-----------------
* Behavioral: training and follow-up of pharmacists
* Behavioral: patient-directed discontinuation letter


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: training and follow-up of pharmacists|nan|
|Behavioral: patient-directed discontinuation letter|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the implementation strategies |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
community pharmacy services, patient care, outcome assessment, benzodiazepines therapeutic use