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OpenTrials
Completed

NCT Number: NCT03482232

Consequences of Doing What Should Not be Done in Primary Care

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.

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Key information

Conditions

Overdose Adverse Event Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

FISABIO, Elche, Alicante, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients visiting GPs

Exclusion criteria

  • None

Treatment and study plan

Benzodiazepines

Drug

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

Non-steroidal anti-inflammatory drugs

Drug

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

Paracetamol

Drug

paracetamol 1g for more than 3 days

Antimicrobial agent

Drug

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

Other names: Antibiotics

Lipid-lowering drug

Drug

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

Prostate cancer

Diagnostic Test

Screening for prostate cancer in asymptomatic patients

Lumbago

Radiation

image tests in non-specific lumbago

Mucolytic

Drug

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

Other names: Mucolytics

Ibuprofen and paracetamol

Drug

treatment with ibuprofen and paracetamol (infants)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

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

Registry information

Acronym: SOBRINA

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 29, 2018
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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