Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron

Overactive Bladder Syndrome Clinical Trial

Official title:

Effectiveness of a Structured Intervention to Optimize Both the Use of Mirabegron, a β3 Receptor Agonist, and Facilitate Its Discontinuation: a Quasi-experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536494
• Other study ID #: ICS-MIR-2018-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: November 2018
• Source: Catalan Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A quasi-experimental design with before/after measurement and a control group was used.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1932
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients under 18 years

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catalan Institute of Health

References & Publications (7)

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, V — View Citation

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. — View Citation

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 t — View Citation

Reeve E, Gnjidic D, Long J, Hilmer S. A systematic review of the emerging de?nition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol. 2015 Dec;80(6):1254-68. Review. — View Citation

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/jamain — View Citation

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.309 — View Citation

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). — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0)	Time from treatment commencement to discontinuation in real clinical practice	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	Prevalence of patients with treatment	Number of participants with treatment before and after the intervention per 1000 patients >64 years of age attended in 1 year	Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion