Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT03536494
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).\n\nControl group (CG): All the other patients with mirabegron prescription assigned to any of the other 34 PHC located in Barcelona belonging to the CIH.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1932}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-06', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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)'}], 'secondaryOutcomes': [{'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', 'description': 'Time from treatment commencement to discontinuation in real clinical practice'}, {'measure': 'Prevalence of patients with treatment', 'timeFrame': 'Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion', 'description': 'Number of participants with treatment before and after the intervention per 1000 patients \\>64 years of age attended in 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overactive bladder', 'Mirabegron', 'Persistence', 'Patient-Centered Care', 'Inappropriate prescribing', 'Discontinuation'], 'conditions': ['Overactive Bladder Syndrome']}, 'referencesModule': {'references': [{'pmid': '17049716', 'type': 'RESULT', '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.'}, {'pmid': '27006985', 'type': 'RESULT', '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."}, {'pmid': '25798731', 'type': 'RESULT', '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.'}, {'pmid': '26644809', 'type': 'RESULT', '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.'}, {'pmid': '28413126', 'type': 'RESULT', '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.'}, {'pmid': '28906080', 'type': 'RESULT', '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.'}, {'pmid': '26803838', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIntervention group: Patients with mirabegron prescription assigned to any of the 17 primary health care centers (PHC) located in the northern area of Barcelona.\n\nControl 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).\n\nThe 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).\n\nThe follow-up period was 12 months, from January 1st to December 31st, 2017.', 'detailedDescription': 'A quasi-experimental design with before/after measurement and a control group was used.\n\nThe 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.\n\nControl group: Usual care\n\nIntervention:\n\n* Initiatives for healthcare professionals: information and training with written material, in an diagram format, distributed to all general practitioners.\n* Initiatives for specialized hospital care: information regarding the intervention for urologists and gynaecologists.\n* Management support with the definition of a structured strategy for all the addresses of the PHC and GPs.\n* Monthly monitoring of the intervention (feed-back to all GPs).\n\nThe 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.\n\nIf considered appropriate, and with the consent of the patient, the medication was withdrawn.\n\nA pharmacist and a clinical pharmacologist acted as consultants in case of any doubts regarding specific patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years with mirabegron prescription. The prescription could be performed by a hospital or primary care doctor.\n\nExclusion Criteria:\n\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT03536494', 'briefTitle': 'Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Catalan Institute of Health'}, 'officialTitle': 'Effectiveness of a Structured Intervention to Optimize Both the Use of Mirabegron, a β3 Receptor Agonist, and Facilitate Its Discontinuation: a Quasi-experimental Study', 'orgStudyIdInfo': {'id': 'ICS-MIR-2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirabegron intervention', 'description': 'Review the use of mirabegron and its discontinuation', 'interventionNames': ['Behavioral: Review the use of mirabegron and its discontinuation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care'}], 'interventions': [{'name': 'Review the use of mirabegron and its discontinuation', 'type': 'BEHAVIORAL', 'description': 'A structured intervention was designed consisting of four major sections:\n\n* General practitioners: information and training with written material and patient-centred prescribing.\n* Specialized hospital care: information regarding the intervention for urologists and gynaecologists.\n* Management support with the definition of a structured strategy.\n* Monthly monitoring of the intervention.', 'armGroupLabels': ['Mirabegron intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Eladio Fernández-Liz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmacist'}, {'name': 'Pedro Vivó Tristante, Physician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director. Primary Health Care Center Montcada i Reixac'}, {'name': 'Antonio Aranzana Martínez, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Director. Primary Health Care Center Rio de Janeiro'}, {'name': 'Mª Estrella Barceló Colomer, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Pharmacologist'}, {'name': 'José Ossó Rebull, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Director. Primary Health Care Center Sant Andreu'}, {'name': 'María José López-Dolcet, Physician', 'role': 'STUDY_CHAIR', 'affiliation': 'Director. Primary Health Care Center Service Muntanya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalan Institute of Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eladio Fernandez Liz', 'investigatorAffiliation': 'Catalan Institute of Health'}}}}