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Consequences of Doing What Should Not be Done in Primary Care (SOBRINA)

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ClinicalTrials.gov Identifier: NCT03482232
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Osasunbidea
Servicio Madrileño de Salud, Madrid, Spain
Fondo de Investigacion Sanitaria
AQuAS
Agencia de Calidad Sanitaria de Andalucía
Ministerio de Sanidad, Servicios Sociales e Igualdad
Servicio Aragonés de Salud
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Consellería Sanitat, Generalitat Valenciana
MurciaSalud
Osakidetza
Castilla-La Mancha Health Service
Information provided by (Responsible Party):
José Joaquín Mira, Universidad Miguel Hernandez de Elche

Brief Summary:
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.

Condition or disease Intervention/treatment
Overdose Adverse Event Drug: Benzodiazepines Drug: Non-steroidal anti-inflammatory drugs Drug: paracetamol Drug: Antimicrobial agent Drug: Lipid-lowering drug Diagnostic Test: Prostate cancer Radiation: Lumbago Drug: Mucolytic Drug: Ibuprofen and paracetamol

Detailed Description:

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.

Objective: To analyze the impact of errors (overuse rates based in Do not do recommendations) in clinical practice.

Method: 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.

Setting. Primary care in Andalucía, Aragón, Castilla La Mancha, Comunidad Valenciana, Madrid, Murcia, Navarra y País Vasco, eight autonomous communities in Spain.


Study Type : Observational
Estimated Enrollment : 750000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Consequences of Doing What Should Not be Done in Primary Care
Actual Study Start Date : October 14, 2018
Estimated Primary Completion Date : December 2, 2018
Estimated Study Completion Date : December 30, 2019

Group/Cohort Intervention/treatment
Patients visiting GP
All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Drug: Benzodiazepines
Benzodiazepines for insomnia, agitation or delirium in people older than 65

Drug: Non-steroidal anti-inflammatory drugs
Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis

Drug: paracetamol
paracetamol 1g for more than 3 days

Drug: Antimicrobial agent
antibiotic in acute bronchitis when the patient does not suffer from COPD, heart failure, diabetes or kidney disease or is undergoing active chemotherapy
Other Name: Antibiotics

Drug: Lipid-lowering drug
Lipid-lowering drugs in patients older than 75 years without previous cardiovascular events

Diagnostic Test: Prostate cancer
Screening for prostate cancer in asymptomatic patients

Radiation: Lumbago
image tests in non-specific lumbago

Patient visiting pediatricians
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.
Drug: Antimicrobial agent
antibiotics for pharyngitis (infants)
Other Name: Antibiotics

Drug: Mucolytic
mucolytics, antitussives or antibiotics for upper respiratory infections (infants)
Other Name: Mucolytics

Drug: Ibuprofen and paracetamol
treatment with ibuprofen and paracetamol (infants)




Primary Outcome Measures :
  1. Medical overuse [ Time Frame: Three years ]
    Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse

  2. Medical overuse [ Time Frame: Three years ]
    Inadequate test for lumbalgia or prostate cancer


Secondary Outcome Measures :
  1. Adverse events as consequence of inadequate clinical decision [Safety] [ Time Frame: Three years ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients data codified in the primary care databases (BDCAP and BIFAP)
Criteria

Inclusion Criteria:

  • All patients visiting GPs

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482232


Locations
Spain
FISABIO
Elche, Alicante, Spain, 03202
Universidad Miguel Hernández
Elche, Alicante, Spain, 03202
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Osasunbidea
Servicio Madrileño de Salud, Madrid, Spain
Fondo de Investigacion Sanitaria
AQuAS
Agencia de Calidad Sanitaria de Andalucía
Ministerio de Sanidad, Servicios Sociales e Igualdad
Servicio Aragonés de Salud
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Consellería Sanitat, Generalitat Valenciana
MurciaSalud
Osakidetza
Castilla-La Mancha Health Service
Investigators
Principal Investigator: JOSE J MIRA, PhD UNIVERSIDAD MIGUEL HERNANDEZ

Publications:

Responsible Party: José Joaquín Mira, Professor, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT03482232     History of Changes
Other Study ID Numbers: PI16/00816
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Public and safety patient researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: December 2019
Access Criteria: http://www.nohacer.es
URL: http://www.nohacer.es

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by José Joaquín Mira, Universidad Miguel Hernandez de Elche:
patient safety
quality assurance
overuse

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Acetaminophen
Anti-Inflammatory Agents
Anti-Infective Agents
Hypolipidemic Agents
Expectorants
Antitubercular Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics
Antimetabolites
Lipid Regulating Agents
Respiratory System Agents