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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
Catalan Institute of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 23, 2018
    Last Updated
    November 6, 2018
    Sponsor
    Catalan Institute of Health
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    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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