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

April 1, 2020 updated by: José Joaquín Mira, Universidad Miguel Hernandez de Elche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

750000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Universidad Miguel Hernández
      • Elche, Alicante, Spain, 03202
        • FISABIO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients data codified in the primary care databases (BDCAP and BIFAP)

Description

Inclusion Criteria:

  • All patients visiting GPs

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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
Drug: Antimicrobial agent
antibiotics for pharyngitis (infants)
Other Names:
  • Antibiotics
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
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
Drug: Antimicrobial agent
antibiotics for pharyngitis (infants)
Other Names:
  • Antibiotics
Drug: Mucolytic
mucolytics, antitussives or antibiotics for upper respiratory infections (infants)
Other Names:
  • Mucolytics
Drug: Ibuprofen and paracetamol
treatment with ibuprofen and paracetamol (infants)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical overuse
Time Frame: Three years
Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse
Three years
Medical overuse
Time Frame: Three years
Inadequate test for lumbalgia or prostate cancer
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2018

Primary Completion (ACTUAL)

December 5, 2019

Study Completion (ACTUAL)

February 10, 2020

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (ACTUAL)

March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/00816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Public and safety patient researchers

IPD Sharing Time Frame

December 2019

IPD Sharing Access Criteria

http://www.nohacer.es

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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