Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
NCT ID: NCT03536494
Last Updated: 2018-11-07
Study Results
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Basic Information
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COMPLETED
NA
1932 participants
INTERVENTIONAL
2017-01-01
2017-12-31
Brief Summary
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Intervention group: Patients with mirabegron prescription assigned to any of the 17 primary health care centers (PHC) located in the northern area of Barcelona.
Control group: All the other patients assigned to any of the other 34 health care centers in Barcelona belonging to the Catalan Institut of Health (CIH).
The structured intervention included initiatives with general practitioners and urologists/gynaecologists, management support from health care authorities, and monthly feed-back monitoring to general practitioners (GPs).
The follow-up period was 12 months, from January 1st to December 31st, 2017.
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Detailed Description
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The objective was to identify the effectiveness of a training activity on the review of treatments. In addition, it was proposed to establish the duration of medication in real clinical practice, and its prevalence of use before and after the intervention.
Control group: Usual care
Intervention:
* Initiatives for healthcare professionals: information and training with written material, in an diagram format, distributed to all general practitioners.
* Initiatives for specialized hospital care: information regarding the intervention for urologists and gynaecologists.
* Management support with the definition of a structured strategy for all the addresses of the PHC and GPs.
* Monthly monitoring of the intervention (feed-back to all GPs).
The intervention consisted of: a) meetings with all the directors of the PHC; b) informative meetings and sessions in the PHC; c) distribution of the diagram to all the GPs; d) lists of patients with treatment provided periodically from the medication area; and e) review of the treatments by the GPs.
If considered appropriate, and with the consent of the patient, the medication was withdrawn.
A pharmacist and a clinical pharmacologist acted as consultants in case of any doubts regarding specific patients.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Control group (CG): All the other patients with mirabegron prescription assigned to any of the other 34 PHC located in Barcelona belonging to the CIH.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Mirabegron intervention
Review the use of mirabegron and its discontinuation
Review the use of mirabegron and its discontinuation
A structured intervention was designed consisting of four major sections:
* General practitioners: information and training with written material and patient-centred prescribing.
* Specialized hospital care: information regarding the intervention for urologists and gynaecologists.
* Management support with the definition of a structured strategy.
* Monthly monitoring of the intervention.
Control group
Usual care
No interventions assigned to this group
Interventions
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Review the use of mirabegron and its discontinuation
A structured intervention was designed consisting of four major sections:
* General practitioners: information and training with written material and patient-centred prescribing.
* Specialized hospital care: information regarding the intervention for urologists and gynaecologists.
* Management support with the definition of a structured strategy.
* Monthly monitoring of the intervention.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Catalan Institute of Health
OTHER_GOV
Responsible Party
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Eladio Fernandez Liz
Principal Investigator
Principal Investigators
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Eladio Fernández-Liz, PhD
Role: PRINCIPAL_INVESTIGATOR
Pharmacist
Pedro Vivó Tristante, Physician
Role: STUDY_DIRECTOR
Director. Primary Health Care Center Montcada i Reixac
Antonio Aranzana Martínez, Physician
Role: STUDY_CHAIR
Director. Primary Health Care Center Rio de Janeiro
Mª Estrella Barceló Colomer, Physician
Role: STUDY_CHAIR
Clinical Pharmacologist
José Ossó Rebull, Physician
Role: STUDY_CHAIR
Director. Primary Health Care Center Sant Andreu
María José López-Dolcet, Physician
Role: STUDY_CHAIR
Director. Primary Health Care Center Service Muntanya
References
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Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
Reeve E, Gnjidic D, Long J, Hilmer S. A systematic review of the emerging de fi nition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol. 2015 Dec;80(6):1254-68. doi: 10.1111/bcp.12732.
Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.
Wagg A, Franks B, Ramos B, Berner T. Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):343-50. doi: 10.5489/cuaj.3098.
Chapple CR, Cruz F, Deffieux X, Milani AL, Arlandis S, Artibani W, Bauer RM, Burkhard F, Cardozo L, Castro-Diaz D, Cornu JN, Deprest J, Gunnemann A, Gyhagen M, Heesakkers J, Koelbl H, MacNeil S, Naumann G, Roovers JWR, Salvatore S, Sievert KD, Tarcan T, Van der Aa F, Montorsi F, Wirth M, Abdel-Fattah M. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017 Sep;72(3):424-431. doi: 10.1016/j.eururo.2017.03.048. Epub 2017 Apr 14.
Wagg AS, Foley S, Peters J, Nazir J, Kool-Houweling L, Scrine L. Persistence and adherence with mirabegron vs antimuscarinics in overactive bladder: Retrospective analysis of a UK General Practice prescription database. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12996. Epub 2017 Sep 14.
Duckett J, Balachandran A. Tolerability and persistence in a large, prospective case series of women prescribed mirabegron. Int Urogynecol J. 2016 Aug;27(8):1163-7. doi: 10.1007/s00192-016-2945-4. Epub 2016 Jan 23.
Other Identifiers
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ICS-MIR-2018-01
Identifier Type: -
Identifier Source: org_study_id
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