Consequences of Doing What Should Not be Done in Primary Care

NCT03482232 | Completed DMC

• 1 other identifier: PI16/00816
• Study Type: observational
• Target: 750,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Overdose; Adverse Event

Keywords

patient safety; quality assurance; overuse

Outcome Measures

Primary Outcomes (2)

• Medical overuse

  Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse

  Three years

• Medical overuse

  Inadequate test for lumbalgia or prostate cancer

  Three years

Secondary Outcomes (1)

• Adverse events as consequence of inadequate clinical decision [Safety]

  Three years

Study Arms (2)

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; Drug: Non-steroidal anti-inflammatory drugs; Drug: paracetamol; Drug: Antimicrobial agent; Drug: Lipid-lowering drug; Diagnostic Test: Prostate cancer; Radiation: 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; Drug: Mucolytic; Drug: Ibuprofen and paracetamol

Interventions

Benzodiazepines DRUG

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

Patients visiting GP

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

Patients visiting GP

paracetamol DRUG

paracetamol 1g for more than 3 days

Patients visiting GP

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

Also known as: Antibiotics

Patients visiting GP

Lipid-lowering drug DRUG

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

Patients visiting GP

Prostate cancer DIAGNOSTIC_TEST

Screening for prostate cancer in asymptomatic patients

Patients visiting GP

Lumbago RADIATION

image tests in non-specific lumbago

Patients visiting GP

Mucolytic DRUG

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

Also known as: Mucolytics

Patient visiting pediatricians

Ibuprofen and paracetamol DRUG

treatment with ibuprofen and paracetamol (infants)

Patient visiting pediatricians

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients visiting GPs

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (2)

FISABIO

Elche, Alicante, 03202, Spain

Location

Universidad Miguel Hernández

Elche, Alicante, 03202, Spain

Location

Related Publications (9)

• Gibson R. The human cost of overuse. BMJ. 2014 May 6;348:g2975. doi: 10.1136/bmj.g2975. No abstract available.

  PMID: 24803401 BACKGROUND

• Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, Nagpal S, Saini V, Srivastava D, Chalmers K, Korenstein D. Evidence for overuse of medical services around the world. Lancet. 2017 Jul 8;390(10090):156-168. doi: 10.1016/S0140-6736(16)32585-5. Epub 2017 Jan 9.

  PMID: 28077234 BACKGROUND

• Segal JB, Bridges JF, Chang HY, Chang E, Nassery N, Weiner J, Chan KS. Identifying possible indicators of systematic overuse of health care procedures with claims data. Med Care. 2014 Feb;52(2):157-63. doi: 10.1097/MLR.0000000000000052.

  PMID: 24374418 BACKGROUND

• Rosenberg A, Agiro A, Gottlieb M, Barron J, Brady P, Liu Y, Li C, DeVries A. Early Trends Among Seven Recommendations From the Choosing Wisely Campaign. JAMA Intern Med. 2015 Dec;175(12):1913-20. doi: 10.1001/jamainternmed.2015.5441.

  PMID: 26457643 BACKGROUND

• Grady D, Redberg RF. Less is more: how less health care can result in better health. Arch Intern Med. 2010 May 10;170(9):749-50. doi: 10.1001/archinternmed.2010.90. No abstract available.

  PMID: 20458080 BACKGROUND

• Aranaz-Andres JM, Aibar C, Limon R, Mira JJ, Vitaller J, Agra Y, Terol E. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health. 2012 Dec;22(6):921-5. doi: 10.1093/eurpub/ckr168. Epub 2011 Nov 29.

  PMID: 23180803 BACKGROUND

• Newton EH, Zazzera EA, Van Moorsel G, Sirovich BE. Undermeasuring Overuse--An Examination of National Clinical Performance Measures. JAMA Intern Med. 2015 Oct;175(10):1709-11. doi: 10.1001/jamainternmed.2015.4025. No abstract available.

  PMID: 26258406 BACKGROUND

• Mira JJ, Carrillo I, Perez-Perez P, Astier-Pena MP, Caro-Mendivelso J, Olivera G, Silvestre C, Nuin MA, Aranaz-Andres JM; on behalf the SOBRINA Research Team. Avoidable Adverse Events Related to Ignoring the Do-Not-Do Recommendations: A Retrospective Cohort Study Conducted in the Spanish Primary Care Setting. J Patient Saf. 2021 Dec 1;17(8):e858-e865. doi: 10.1097/PTS.0000000000000830.

  PMID: 34009877 DERIVED

• Mira JJ, Carrillo I, Gea Velazquez de Castro MT, Silvestre C, Olivera G, Caro-Mendivelso J, Perez-Perez P, Agra Y, Fernandez AM, Aranaz-Andres JM; SOBRINA Research Team. SOBRINA Spanish study-analysing the frequency, cost and adverse events associated with overuse in primary care: protocol for a retrospective cohort study. BMJ Open. 2019 Mar 4;9(3):e023399. doi: 10.1136/bmjopen-2018-023399.

  PMID: 30837247 DERIVED

MeSH Terms

Conditions

Drug Overdose

Interventions

Benzodiazepines; Acetaminophen; Anti-Infective Agents; Anti-Bacterial Agents; Hypolipidemic Agents; Expectorants; Ibuprofen

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Respiratory System Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• JOSE J MIRA, PhD

  UNIVERSIDAD MIGUEL HERNANDEZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 29, 2018
• Study Start: October 14, 2018
• Primary Completion: December 5, 2019
• Study Completion: February 10, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 2019
• Access Criteria: http://www.nohacer.es

Locations

ES (2)