Condition category
Mental and Behavioural Disorders
Date applied
02/02/2016
Date assigned
06/04/2016
Last edited
06/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Clinicians mainly prescribe benzodiazepines (BZDs) to treat anxiety and insomnia, or as adjuvants (i.e. in addition to other therapy) in treatment of depression. International guidelines specifically recommend short-term use because long-term use can increase the risk of cognitive impairment (not being able to think clearly), falls, fractures, and mortality (death). Despite these potentially harmful consequences, many physicians prescribe BZDs for long periods. General practitioners (GPs) issue most of these prescriptions, so withdrawal should also be managed by GPs; however, doctors and patients often consider stopping BZD as very challenging. A primary care (GP-run) structured intervention (program) to reduce the use of BZD has led to a significant drop in the number of long-term benzodiazepine users. The aim of this study is to see whether GPs that have had workshop training in BZD prescription/discontinuation and have been provided with information on the BZDs they give to patients (prescribe) every month will prescribe less of them than GPs that are not given the training or information.

Who can participate?
GPs working in Balearic Island Primary Care, Tarragona-Reus Primary Care and Arnau de Vilanova-llíria Primary Care health care centers.

What does the study involve?
Health care centers enrolled in the study are randomly allocated to one of two groups, an intervention and a control group. GPs working in a health care center allocated to the intervention group attend a two hour workshop about BZD prescription and discontinuation. They then receive monthly information about the BZD prescriptions they provide over the next year. GPs working in a health center allocated to the control group do not receive any specific training, nor information about their prescriptions. All GPs are assessed after a year to see whether they have reduced the number of BZD prescriptions they provide.

What are the possible benefits and risks of participating?
GPs may benefit from a specific training in BZD prescription and discontinuation and their patients may benefit from reducing their use of these drugs. There are no known risks to participants taking part in this study.

Where is the study run from?
Son Serra- La Vileta Health care center, Palma (Spain)

When is the study starting and how long is it expected to run for?
January 2016 to December 2018

Who is funding the study?
Carlos III Health Institute of the Ministry of Economy and Competitiveness (Spain)

Who is the main contact?
Dr Caterina Vicens (scientific)
cvicenscaldentey@ibsalut.caib.es

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Catalina Vicens

ORCID ID

Contact details

C/ Matamusinos
n22
Palma
07011
Spain
0034971793193
caterinavicens@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI15/01480

Study information

Scientific title

Evaluation of a multifactorial intervention to reduce the consumption of benzodiazepines in primary care. A randomized cluster clinical trial

Acronym

BENZORED fase 4

Study hypothesis

A multifactorial intervention addressed to general practitioners including a two hours workshop training and followed by benzodiazepine prescription feed-back is effective in reducing benzodiazepine prescription.

Ethics approval

Balearic Island Ethic Committee, 10/11/2015, ref: IB 3065/15

Study design

Cluster randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Benzodiazepine consumption

Intervention

Health centers enrolled in the study are randomly assigned to a intervention or a control group.
1. Intervention group: All GPs working in one of the intervention health centers attend a two hours workshop about the use of benzodiazepines and provided with monthly information about their benzodiazepine prescription indicators (DHD)
2. Control group: All GPs in this arm do not receive any specific training or information about their prescriptions

Intervention type

Drug

Phase

Phase IV

Drug names

Benzodiazepine

Primary outcome measures

Total GP Doses per 1000 Habitants per Day (DHD) of benzodiazepine at 12 months.

Secondary outcome measures

1. Percentage of total long term benzodiazepine users at 12 months, measured via information about patient prescribed benzodiacepine for a period longer than six months registered in the prescription database of the electronic health records
2. Percentage of patient older than 65 long term benzodizepine users at 12 months, measured via information about patient older than 65 with a prescription of benzodiazepine registered in the prescription database of the electronic health records
3. Feasibility, adoption and fidelity of the intervention will be measured by an "Ad hoc" questionnaire to measure GP opinion

Overall trial start date

01/01/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

All GPs from the health centers where the trials will be implemented.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

508 GPs

Participant exclusion criteria

Unwillingness to participate

Recruitment start date

01/06/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Spain

Trial participating centre

IB-Salut (Balearic Island Primary Care)
07005
Spain

Trial participating centre

Cat-Salut (Tarragona-Reus Primary Care)
43480
Spain

Trial participating centre

Agencia Valenciana de Salut (Arnau de Vilanova-llíria Primary Care)
46980
Spain

Sponsor information

Organisation

Primary Care Management of Mallorca (Gerencia de Atención Primaria de Mallorca)

Sponsor details

C/ Reina Esclaramunda 9
palma
07003
Spain
0034971175893
aleiva@ibsalut.caib.es

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Carlos III Health Institute (Instituto De Salud Carlos III) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. The effectiveness of the intervention will be published in a Primary Care/General Medicine journal
2. The factibility, adoption , feasibility and fideliy will be published in a Primary Care journal

Intention to publish date

01/06/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes