Clinical trial NCT03536494: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder Syndrome
Keywords: Overactive bladder
Mirabegron
Persistence
Patient-Centered Care
Inappropriate prescribing
Discontinuation
Lead sponsor: Catalan Institute of Health
Sponsor class: OTHER_GOV
First posted: 2018-05-24
Enrollment: 1932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change from baseline of the number of participants with treatment
timeFrame: 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 outcomes:
measure: Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0)
timeFrame: 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
measure: Prevalence of patients with treatment
timeFrame: Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Pharmacist
name: Eladio Fernández-Liz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director. Primary Health Care Center Montcada i Reixac
name: Pedro Vivó Tristante, Physician
role: STUDY_DIRECTOR
affiliation: Director. Primary Health Care Center Rio de Janeiro
name: Antonio Aranzana Martínez, Physician
role: STUDY_CHAIR
affiliation: Clinical Pharmacologist
name: Mª Estrella Barceló Colomer, Physician
role: STUDY_CHAIR
affiliation: Director. Primary Health Care Center Sant Andreu
name: José Ossó Rebull, Physician
role: STUDY_CHAIR
affiliation: Director. Primary Health Care Center Service Muntanya
name: María José López-Dolcet, Physician
role: STUDY_CHAIR
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