Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron

Study Overview
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Brief Summary
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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.

Detailed Description
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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 If considered appropriate, and with the consent of the patient, the medication was withdrawn.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.

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

Conditions
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Overactive Bladder Syndrome

Intervention / Treatment
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* Behavioral: Review the use of mirabegron and its discontinuation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirabegron intervention<br>Review the use of mirabegron and its discontinuation | Behavioral: Review the use of mirabegron and its discontinuation<br>* 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.<br>|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Mirabegron, Persistence, Patient-Centered Care, Inappropriate prescribing, Discontinuation