Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03536494|
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : November 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Behavioral: Review the use of mirabegron and its discontinuation||Not Applicable|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1932 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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.
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Experimental: Mirabegron intervention
Review the use of mirabegron and its discontinuation
Behavioral: Review the use of mirabegron and its discontinuation
A structured intervention was designed consisting of four major sections:
No Intervention: Control group
- Change from baseline of the number of participants with treatment [ Time Frame: 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 ]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)
- Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0) [ Time Frame: 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 ]Time from treatment commencement to discontinuation in real clinical practice
- Prevalence of patients with treatment [ Time Frame: Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion ]Number of participants with treatment before and after the intervention per 1000 patients >64 years of age attended in 1 year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536494
|Principal Investigator:||Eladio Fernández-Liz, PhD||Pharmacist|
|Study Director:||Pedro Vivó Tristante, Physician||Director. Primary Health Care Center Montcada i Reixac|
|Study Chair:||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|