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  • Intervention to reduce benzodiazepine prescriptions in primary care, study protocol of a hybrid type 1 cluster randomised controlled trial: the BENZORED study

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Health services research
Protocol
Intervention to reduce benzodiazepine prescriptions in primary care, study protocol of a hybrid type 1 cluster randomised controlled trial: the BENZORED study
  1. Caterina Vicens1,2,
  2. Alfonso Leiva2,3,
  3. Ferran Bejarano4,
  4. Ermengol Sempere5,
  5. Raquel María Rodríguez-Rincón6,
  6. Francisca Fiol1,
  7. Marta Mengual4,
  8. Asunción Ajenjo5,
  9. Fernando Do Pazo6,
  10. Catalina Mateu1,2,
  11. Silvia Folch4,
  12. Santiago Alegret1,
  13. Jose Maria Coll7,
  14. María Martín-Rabadán8,
  15. Isabel Socias2,9
  1. 1 Son Serra-La Vileta Healthcare Centre, Balearic Health Service Ib-Salut, Palma, Spain
  2. 2 Instituto de Investigación Sanitaria de Baleares (IdISBa), Palma, Spain
  3. 3 Primary Care Reseach Unit, Balearic Health Service Ib-Salut, Palma, Spain
  4. 4 DAP Camp de Tarragona, Catalunya Health Services-CatSalut, Tarragona, Spain
  5. 5 Paterna Healthcare Centre, Conselleria de Sanitat Universal, Agència Valenciana de Salut, Valencia, Spain
  6. 6 Pharmacy Department, Hospital Universitari Son Espases, Palma de Mallorca, Spain
  7. 7 Menorca Primary Care Management, Balearic Health Service Ib-Salut, Mahón, Spain
  8. 8 Can Misses Healthcare Centre, Balearic Health Service Ib-Salut, Ibiza, Spain
  9. 9 Manacor Healthcare Centre, Balearic Health Service Ib-Salut, Manacor, Spain
  1. Correspondence to Dr Alfonso Leiva; aleiva{at}ibsalut.caib.es

Abstract

Introduction Benzodiazepines (BZDs) are mainly used to treat anxiety and sleep disorders, and are often prescribed for long durations, even though prescription guidelines recommend short-term use due to the risk of dependence, cognitive impairment, and falls and fractures. Education of general practitioners (GPs) regarding the prescription of BZDs may reduce the overuse and of these drugs.

The aims of this study are to analyse the effectiveness of an intervention targeted to GPs to reduce BZD prescription and evaluate the implementation process.

Methods and analysis The healthcare centres in three regions of Spain (Balearic Islands, Catalonia and Community of Valencia) will be randomly allocated to receive a multifactorial intervention or usual care (control). GPs in the intervention group will receive a 2-hour workshop about best-practice regarding BZD prescription and BZD deprescribing, monthly feedback about their BZD prescribing practices and access to a support web page. Outcome measures for each GP are the defined daily dosage per 1000 inhabitants per day and the proportion of long-term BZD users at 12 months. Data will be collected from the electronic prescription database of the public health system, and will be subjected to intention-to-treat analysis. Implementation will be evaluated by mixed methods following the five domains of the Consolidated Framework For Implementation Research.

Ethics and dissemination This study was approved by the Balearic Islands Ethical Committee of Clinical Research (IB3065/15), l’IDIAP Jordi Gol Ethical Committee of Clinical Research (PI 15/0148) and Valencia Primary Care Ethical Committee of Clinical Research (P16/024). The results will be submitted for publication in peer-reviewed journals.

Trial registration number ISRCTN28272199.

  • benzodiazepines
  • adverse effects
  • primary health care
  • deprescribing
  • clinical trial

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-022046

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    Footnotes

    • Patient consent for publication Not required.

    • Contributors CV, FB, ES, FDP, RMR-R and AL collectively drafted the study protocol, and sought funding and ethical approval. FDP, RMR-R, CV, ES and FB have access to the GPs’ electronic prescription database, and prepared the monthly report to be sent to the GPs. CV, FB and ES are the steering committee, and are responsible for management of the trial. CV, IS, FF, ES, AA, FB, MM-R, SF, CM and SA are responsible for development and implementation of the training workshop in the practices targeted to GPs. CV, IS, FF, ES, JMC, MM-R, AA, SA, FB, MM, SF, CM and AL will develop the content of the support web page for the study, and develop and implemented the questionnaires. All authors have read the draft critically, made contributions and approved the final manuscript. CV is the principal investigator, will have full access to all the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    • Funding This study was funded by the Ministry of Economy and Competitiveness, Carlos III Institute (www.isciii.es), grant PI15/01480. We also received support from the Health Promotion and Preventive Activities-Primary Health Care Network, sustained by the Ministry of Health ISCIII-RETIC awards RD16/0007/0008, also— supported with European Union ERDF funds.

    • Disclaimer The funders had no role in the study design, data collection, management, analysis, interpretation, decision to publish or preparation of the manuscript.

    • Competing interests None declared.

    • Ethics approval This trial was approved by the Primary Care Research Committee, the Balearic Islands Ethical Committee of Clinical Research (IB3065/15), l’IDIAP Jordi Gol Ethical Committee of Clinical Research (PI 15/0148) and Valencia Primary Care Ethical Committee of Clinical Research (P16/024).

    • Provenance and peer review Not commissioned; externally peer reviewed.