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
+34 (0)971793193
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
Cluster randomised 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
01/06/2016
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
+34 (0)971175893
aleiva@ibsalut.caib.es
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Instituto de Salud Carlos III
Alternative name(s)
Institute of Health Carlos III, Carlos III Health Institute, ISCIII
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Spain
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 fidelity will be published in a Primary Care journal
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Caterina Vicens (caterinavicens@gmail.com). Data that will be shared: individual participant data that underlie the results reported in published articles. Data will be available: beginning 2 months following article publication. Data will be available for researchers who provide a methodologically sound proposal and individual participant data meta-analysis.
Intention to publish date
01/06/2019
Participant level data
Available on request
Results - basic reporting
Publication summary