Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT03482232
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Consequences of Doing What Should Not be Done in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062787', 'term': 'Drug Overdose'}], 'ancestors': [{'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D005100', 'term': 'Expectorants'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D019141', 'term': 'Respiratory System Agents'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical overuse', 'timeFrame': 'Three years', 'description': 'Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse'}, {'measure': 'Medical overuse', 'timeFrame': 'Three years', 'description': 'Inadequate test for lumbalgia or prostate cancer'}], 'secondaryOutcomes': [{'measure': 'Adverse events as consequence of inadequate clinical decision [Safety]', 'timeFrame': 'Three years', 'description': 'Patients suffering hurt due to inadequate prescription or inadequate test. Inadequate prescriptions or tests as defined by Do-not-Do recommendations. These were defined by Spanish Primary Care Scientific Societies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient safety', 'quality assurance', 'overuse'], 'conditions': ['Overdose', 'Adverse Event']}, 'referencesModule': {'references': [{'pmid': '24803401', 'type': 'BACKGROUND', 'citation': 'Gibson R. The human cost of overuse. BMJ. 2014 May 6;348:g2975. doi: 10.1136/bmj.g2975. No abstract available.'}, {'pmid': '28077234', 'type': 'BACKGROUND', 'citation': 'Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, Nagpal S, Saini V, Srivastava D, Chalmers K, Korenstein D. Evidence for overuse of medical services around the world. Lancet. 2017 Jul 8;390(10090):156-168. doi: 10.1016/S0140-6736(16)32585-5. Epub 2017 Jan 9.'}, {'pmid': '24374418', 'type': 'BACKGROUND', 'citation': 'Segal JB, Bridges JF, Chang HY, Chang E, Nassery N, Weiner J, Chan KS. Identifying possible indicators of systematic overuse of health care procedures with claims data. Med Care. 2014 Feb;52(2):157-63. doi: 10.1097/MLR.0000000000000052.'}, {'pmid': '26457643', 'type': 'BACKGROUND', 'citation': 'Rosenberg A, Agiro A, Gottlieb M, Barron J, Brady P, Liu Y, Li C, DeVries A. Early Trends Among Seven Recommendations From the Choosing Wisely Campaign. JAMA Intern Med. 2015 Dec;175(12):1913-20. doi: 10.1001/jamainternmed.2015.5441.'}, {'pmid': '20458080', 'type': 'BACKGROUND', 'citation': 'Grady D, Redberg RF. Less is more: how less health care can result in better health. Arch Intern Med. 2010 May 10;170(9):749-50. doi: 10.1001/archinternmed.2010.90. No abstract available.'}, {'pmid': '23180803', 'type': 'BACKGROUND', 'citation': 'Aranaz-Andres JM, Aibar C, Limon R, Mira JJ, Vitaller J, Agra Y, Terol E. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health. 2012 Dec;22(6):921-5. doi: 10.1093/eurpub/ckr168. Epub 2011 Nov 29.'}, {'pmid': '26258406', 'type': 'BACKGROUND', 'citation': 'Newton EH, Zazzera EA, Van Moorsel G, Sirovich BE. Undermeasuring Overuse--An Examination of National Clinical Performance Measures. JAMA Intern Med. 2015 Oct;175(10):1709-11. doi: 10.1001/jamainternmed.2015.4025. No abstract available.'}, {'pmid': '34009877', 'type': 'DERIVED', 'citation': 'Mira JJ, Carrillo I, Perez-Perez P, Astier-Pena MP, Caro-Mendivelso J, Olivera G, Silvestre C, Nuin MA, Aranaz-Andres JM; on behalf the SOBRINA Research Team. Avoidable Adverse Events Related to Ignoring the Do-Not-Do Recommendations: A Retrospective Cohort Study Conducted in the Spanish Primary Care Setting. J Patient Saf. 2021 Dec 1;17(8):e858-e865. doi: 10.1097/PTS.0000000000000830.'}, {'pmid': '30837247', 'type': 'DERIVED', 'citation': 'Mira JJ, Carrillo I, Gea Velazquez de Castro MT, Silvestre C, Olivera G, Caro-Mendivelso J, Perez-Perez P, Agra Y, Fernandez AM, Aranaz-Andres JM; SOBRINA Research Team. SOBRINA Spanish study-analysing the frequency, cost and adverse events associated with overuse in primary care: protocol for a retrospective cohort study. BMJ Open. 2019 Mar 4;9(3):e023399. doi: 10.1136/bmjopen-2018-023399.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them and study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.', 'detailedDescription': 'Basement: Overuse subjected patients to unnecessary risk without promoting a sufficient clinical benefit and over-cost. The Less is More Medicine movement has led to the identification of Do not do in different specialties, also in primary care.\n\nObjective: To analyze the impact of errors (overuse rates based in Do not do recommendations) in clinical practice.\n\nMethod: Retrospective observational study in a random selection of 5% of digital records active between 2014 and 2017 to quantify the frequency of Do not do primary care recommendations, calculating the over-cost related to them. Retrospective study reviewing a random selection of cases previously identified to determine whether patient suffered adverse events and their over-cost.\n\nSetting. Primary care in Andalucía, Aragón, Castilla La Mancha, Comunidad Valenciana, Madrid, Murcia, Navarra y País Vasco, eight autonomous communities in Spain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients data codified in the primary care databases (BDCAP and BIFAP)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients visiting GPs\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03482232', 'acronym': 'SOBRINA', 'briefTitle': 'Consequences of Doing What Should Not be Done in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Consequences of Doing What Should Not be Done in Primary Care', 'orgStudyIdInfo': {'id': 'PI16/00816'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients visiting GP', 'description': 'All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.', 'interventionNames': ['Drug: Benzodiazepines', 'Drug: Non-steroidal anti-inflammatory drugs', 'Drug: paracetamol', 'Drug: Antimicrobial agent', 'Drug: Lipid-lowering drug', 'Diagnostic Test: Prostate cancer', 'Radiation: Lumbago']}, {'label': 'Patient visiting pediatricians', 'description': 'All patients visiting pediatricians (0 to 14 years old). The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.', 'interventionNames': ['Drug: Antimicrobial agent', 'Drug: Mucolytic', 'Drug: Ibuprofen and paracetamol']}], 'interventions': [{'name': 'Benzodiazepines', 'type': 'DRUG', 'description': 'Benzodiazepines for insomnia, agitation or delirium in people older than 65', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'Non-steroidal anti-inflammatory drugs', 'type': 'DRUG', 'description': 'Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'paracetamol', 'type': 'DRUG', 'description': 'paracetamol 1g for more than 3 days', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'Antimicrobial agent', 'type': 'DRUG', 'otherNames': ['Antibiotics'], 'description': 'antibiotic in acute bronchitis when the patient does not suffer from COPD, heart failure, diabetes or kidney disease or is undergoing active chemotherapy', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'Lipid-lowering drug', 'type': 'DRUG', 'description': 'Lipid-lowering drugs in patients older than 75 years without previous cardiovascular events', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'Prostate cancer', 'type': 'DIAGNOSTIC_TEST', 'description': 'Screening for prostate cancer in asymptomatic patients', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'Lumbago', 'type': 'RADIATION', 'description': 'image tests in non-specific lumbago', 'armGroupLabels': ['Patients visiting GP']}, {'name': 'Antimicrobial agent', 'type': 'DRUG', 'otherNames': ['Antibiotics'], 'description': 'antibiotics for pharyngitis (infants)', 'armGroupLabels': ['Patient visiting pediatricians']}, {'name': 'Mucolytic', 'type': 'DRUG', 'otherNames': ['Mucolytics'], 'description': 'mucolytics, antitussives or antibiotics for upper respiratory infections (infants)', 'armGroupLabels': ['Patient visiting pediatricians']}, {'name': 'Ibuprofen and paracetamol', 'type': 'DRUG', 'description': 'treatment with ibuprofen and paracetamol (infants)', 'armGroupLabels': ['Patient visiting pediatricians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'FISABIO', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Universidad Miguel Hernández', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'overallOfficials': [{'name': 'JOSE J MIRA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIVERSIDAD MIGUEL HERNANDEZ'}]}, 'ipdSharingStatementModule': {'url': 'http://www.nohacer.es', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'December 2019', 'ipdSharing': 'YES', 'description': 'Public and safety patient researchers', 'accessCriteria': 'http://www.nohacer.es'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, 'collaborators': [{'name': 'Osasunbidea', 'class': 'UNKNOWN'}, {'name': 'Servicio Madrileño de Salud, Madrid, Spain', 'class': 'OTHER'}, {'name': 'Fondo de Investigacion Sanitaria', 'class': 'OTHER'}, {'name': 'AQuAS', 'class': 'UNKNOWN'}, {'name': 'Agencia de Calidad Sanitaria de Andalucía', 'class': 'UNKNOWN'}, {'name': 'Ministerio de Sanidad, Servicios Sociales e Igualdad', 'class': 'OTHER_GOV'}, {'name': 'Servicio Aragones De Salud', 'class': 'OTHER'}, {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, {'name': 'Generalitat Valenciana', 'class': 'OTHER'}, {'name': 'MurciaSalud', 'class': 'OTHER_GOV'}, {'name': 'Osakidetza', 'class': 'OTHER'}, {'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'José Joaquín Mira', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}