Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron

November 6, 2018 updated by: Eladio Fernandez Liz, Catalan Institute of Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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If considered appropriate, and with the consent of the patient, the medication was withdrawn.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

Study Type

Interventional

Enrollment (Actual)

1932

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 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
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
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
Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalan Institute of Health

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 24, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICS-MIR-2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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