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Completed

NCT Number: NCT03536494

Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron

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.

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Key information

Conditions

Overactive Bladder Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Review the use of mirabegron and its discontinuation

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalan Institute of Health

Other Gov

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 24, 2018
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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