Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
Primary Purpose
Overactive Bladder Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Review the use of mirabegron and its discontinuation
Sponsored by
About this trial
This is an interventional health services research trial for Overactive Bladder Syndrome focused on measuring Overactive bladder, Mirabegron, Persistence, Patient-Centered Care, Inappropriate prescribing, Discontinuation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mirabegron intervention
Control group
Arm Description
Review the use of mirabegron and its discontinuation
Usual care
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03536494
First Posted
April 23, 2018
Last Updated
November 6, 2018
Sponsor
Catalan Institute of Health
1. Study Identification
Unique Protocol Identification Number
NCT03536494
Brief Title
Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catalan Institute of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
Overactive bladder, Mirabegron, Persistence, Patient-Centered Care, Inappropriate prescribing, Discontinuation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Non-Randomized
Enrollment
1932 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirabegron intervention
Arm Type
Experimental
Arm Description
Review the use of mirabegron and its discontinuation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Review the use of mirabegron and its discontinuation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of the number of participants with treatment
Description
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)
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
Secondary Outcome Measure Information:
Title
Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0)
Description
Time from treatment commencement to discontinuation in real clinical practice
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
Title
Prevalence of patients with treatment
Description
Number of participants with treatment before and after the intervention per 1000 patients >64 years of age attended in 1 year
Time Frame
Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eladio Fernández-Liz, PhD
Organizational Affiliation
Pharmacist
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Vivó Tristante, Physician
Organizational Affiliation
Director. Primary Health Care Center Montcada i Reixac
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antonio Aranzana Martínez, Physician
Organizational Affiliation
Director. Primary Health Care Center Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mª Estrella Barceló Colomer, Physician
Organizational Affiliation
Clinical Pharmacologist
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José Ossó Rebull, Physician
Organizational Affiliation
Director. Primary Health Care Center Sant Andreu
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
María José López-Dolcet, Physician
Organizational Affiliation
Director. Primary Health Care Center Service Muntanya
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17049716
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 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.
Results Reference
result
PubMed Identifier
27006985
Citation
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.
Results Reference
result
PubMed Identifier
25798731
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/jamainternmed.2015.0324.
Results Reference
result
PubMed Identifier
26644809
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.3098.
Results Reference
result
PubMed Identifier
28413126
Citation
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.
Results Reference
result
PubMed Identifier
28906080
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). doi: 10.1111/ijcp.12996. Epub 2017 Sep 14.
Results Reference
result
PubMed Identifier
26803838
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.
Results Reference
result
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Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
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