Consequences of Doing What Should Not be Done in Primary Care

Completed

• Conditions: Overdose; Adverse Event
• Interventions: Drug: Benzodiazepines; Drug: Mucolytic; Drug: Non-steroidal anti-inflammatory drugs; Drug: Ibuprofen and paracetamol; Drug: paracetamol; Drug: Antimicrobial agent; Drug: Lipid-lowering drug; Diagnostic Test: Prostate cancer; Radiation: Lumbago

• Registration Number: NCT03482232
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Study Start: 2018-10-14
• Primary Completion: 2019-12-05
• Study Completion: 2020-02-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750000

Inclusion Criteria

• All patients visiting GPs

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients visiting GP	Antimicrobial agent	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Patients visiting GP	Lumbago	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Patient visiting pediatricians	Mucolytic	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.
Patient visiting pediatricians	Antimicrobial agent	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.
Patients visiting GP	Non-steroidal anti-inflammatory drugs	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Patient visiting pediatricians	Ibuprofen and paracetamol	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.
Patients visiting GP	Benzodiazepines	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Patients visiting GP	Lipid-lowering drug	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Patients visiting GP	Prostate cancer	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Patients visiting GP	paracetamol	All patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.

Primary Outcome Measures

Name	Time	Method
Medical overuse	Three years	Inadequate test for lumbalgia or prostate cancer

Secondary Outcome Measures

Name	Time	Method
Adverse events as consequence of inadequate clinical decision [Safety]	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

Trial Locations

Locations (2)

FISABIO; 🇪🇸 Elche, Alicante, Spain

Universidad Miguel Hernández; 🇪🇸 Elche, Alicante, Spain