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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
Sponsor:
Information provided by (Responsible Party):
Eladio Fernandez Liz, Catalan Institute of Health

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.


Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Behavioral: Review the use of mirabegron and its discontinuation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1932 participants
Allocation: Non-Randomized
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.

Masking: Single (Investigator)
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

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
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:

  • 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.

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Catalan Institute of Health
Investigators
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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
Publications of Results:

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Responsible Party: Eladio Fernandez Liz, Principal Investigator, Catalan Institute of Health
ClinicalTrials.gov Identifier: NCT03536494    
Other Study ID Numbers: ICS-MIR-2018-01
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eladio Fernandez Liz, Catalan Institute of Health:
Overactive bladder
Mirabegron
Persistence
Patient-Centered Care
Inappropriate prescribing
Discontinuation
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents