Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron

NCT03536494 | Completed DMC

• 1 other identifier: ICS-MIR-2018-01
• Study Type: interventional
• Target: 1,932
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was a multicentre, quasi-experimental design, controlled, before-and-after trial to estimate the effectiveness related to the review of mirabegron use and, if appropriate, its discontinuation. 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.

Conditions

Overactive Bladder Syndrome

Keywords

Overactive bladder; Mirabegron; Persistence; Patient-Centered Care; Inappropriate prescribing; Discontinuation

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the number of participants with treatment

  The percentage of change from baseline of the number of participants with treatment at 3, 6, 9 and 12 months with respect to basal values (day 0)

  Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion

Secondary Outcomes (2)

• Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0)

  Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion

• Prevalence of patients with treatment

  Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion

Study Arms (2)

Mirabegron intervention

EXPERIMENTAL

Review the use of mirabegron and its discontinuation

Behavioral: Review the use of mirabegron and its discontinuation

Control group

NO INTERVENTION

Usual care

Interventions

Review the use of mirabegron and its discontinuation BEHAVIORAL

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.

Mirabegron intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years with mirabegron prescription. The prescription could be performed by a hospital or primary care doctor.

You may not qualify if:

• Patients under 18 years

Sponsors & Collaborators

• Catalan Institute of Health: lead

Related Publications (7)

• 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.

  PMID: 17049716 RESULT

• 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.

  PMID: 27006985 RESULT

• 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.

  PMID: 25798731 RESULT

• 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.

  PMID: 26644809 RESULT

• 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.

  PMID: 28413126 RESULT

• 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.

  PMID: 28906080 RESULT

• 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.

  PMID: 26803838 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eladio Fernández-Liz, PhD

  Pharmacist

  PRINCIPAL INVESTIGATOR

• Pedro Vivó Tristante, Physician

  Director. Primary Health Care Center Montcada i Reixac

  STUDY DIRECTOR

• Antonio Aranzana Martínez, Physician

  Director. Primary Health Care Center Rio de Janeiro

  STUDY CHAIR

• Mª Estrella Barceló Colomer, Physician

  Clinical Pharmacologist

  STUDY CHAIR

• José Ossó Rebull, Physician

  Director. Primary Health Care Center Sant Andreu

  STUDY CHAIR

• María José López-Dolcet, Physician

  Director. Primary Health Care Center Service Muntanya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group: Patients with mirabegron prescription from 1st January 2017 to 31st December 2017 assigned to any of the 17 urban primary health care centers located in the northern area of Barcelona belong to the Catalan Institute of Health (CIH). 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.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 24, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: November 7, 2018

Record last verified: 2018-11