A GP training intervention to reduce benzodiazepine prescription in primary care
| ISRCTN | ISRCTN28272199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28272199 |
| Secondary identifying numbers | PI15/01480 |
- Submission date
- 02/02/2016
- Registration date
- 06/04/2016
- Last edited
- 10/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
C/ Matamusinos, n22
Palma
07011
Spain
| Phone | +34 (0)971793193 |
|---|---|
| caterinavicens@gmail.com |
Study information
| Study design | Cluster randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of a multifactorial intervention to reduce the consumption of benzodiazepines in primary care: a randomized cluster clinical trial |
| Study acronym | BENZORED fase 4 |
| Study objectives | 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(s) | Balearic Island Ethic Committee, 10/11/2015, ref: IB 3065/15 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Benzodiazepine |
| Primary outcome measure | 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 study start date | 01/01/2016 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 508 GPs |
| Total final enrolment | 700 |
| Key inclusion criteria | All GPs from the health centers where the trials will be implemented |
| Key exclusion criteria | Unwillingness to participate |
| Date of first enrolment | 01/06/2016 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Spain
Study participating centres
Spain
Spain
Spain
Sponsor information
Government
C/ Reina Esclaramunda 9
palma
07003
Spain
| Phone | +34 (0)971175893 |
|---|---|
| aleiva@ibsalut.caib.es | |
"ROR" |
https://ror.org/00d9y8h06 |
Funders
Funder type
Hospital/treatment centre
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
Results and Publications
| Intention to publish date | 01/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/01/2019 | 16/01/2020 | Yes | No |
| Results article | 06/05/2022 | 09/05/2022 | Yes | No | |
| Results article | 28/07/2021 | 10/05/2024 | Yes | No |
Editorial Notes
10/05/2024: Publication reference added.
09/05/2022: Publication reference and total final enrolment added.
16/01/2020: Publication reference added.
05/02/2018: The recruitment start date was corrected from 01/06/2015 to 01/06/2016 and an IPD sharing statement was added.
