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Consequences of Doing What Should Not be Done in Primary Care

Consequences of Doing What Should Not be Done in Primary Care

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03482232
Acronym
SOBRINA
Enrollment
750000
Registered
2018-03-29
Start date
2018-10-14
Completion date
2020-02-10
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overdose, Adverse Event

Keywords

patient safety, quality assurance, overuse

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.

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.

Interventions

Benzodiazepines for insomnia, agitation or delirium in people older than 65

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

DRUGparacetamol

paracetamol 1g for more than 3 days

antibiotic in acute bronchitis when the patient does not suffer from COPD, heart failure, diabetes or kidney disease or is undergoing active chemotherapy

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

DIAGNOSTIC_TESTProstate cancer

Screening for prostate cancer in asymptomatic patients

RADIATIONLumbago

image tests in non-specific lumbago

mucolytics, antitussives or antibiotics for upper respiratory infections (infants)

DRUGIbuprofen and paracetamol

treatment with ibuprofen and paracetamol (infants)

Sponsors

Osasunbidea
CollaboratorUNKNOWN
Servicio Madrileño de Salud, Madrid, Spain
CollaboratorOTHER
Fondo de Investigacion Sanitaria
CollaboratorOTHER
AQuAS
CollaboratorUNKNOWN
Agencia de Calidad Sanitaria de Andalucía
CollaboratorUNKNOWN
Ministerio de Sanidad, Servicios Sociales e Igualdad
CollaboratorOTHER_GOV
Servicio Aragones De Salud
CollaboratorOTHER
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
CollaboratorOTHER
Generalitat Valenciana
CollaboratorOTHER
MurciaSalud
CollaboratorOTHER_GOV
Osakidetza
CollaboratorOTHER
Castilla-La Mancha Health Service
CollaboratorOTHER
Universidad Miguel Hernandez de Elche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients visiting GPs

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Medical overuseThree yearsInadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse

Secondary

MeasureTime frameDescription
Adverse events as consequence of inadequate clinical decision [Safety]Three yearsPatients 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026