Consequences of Doing What Should Not be Done in Primary Care

Adverse Event Clinical Trial

— SOBRINA  

Official title:

Consequences of Doing What Should Not be Done in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482232
• Other study ID #: PI16/00816
• Status: Completed
• Start date: October 14, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: April 2020
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750000
• Est. completion date: February 10, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients visiting GPs

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Adverse Event
• Drug Overdose
• Overdose

Intervention

Drug:
• Benzodiazepines
Benzodiazepines for insomnia, agitation or delirium in people older than 65
• Non-steroidal anti-inflammatory drugs
Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis
• paracetamol
paracetamol 1g for more than 3 days
• 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
• 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)
• Mucolytic
mucolytics, antitussives or antibiotics for upper respiratory infections (infants)
• Ibuprofen and paracetamol
treatment with ibuprofen and paracetamol (infants)

Locations

Country	Name	City	State
Spain	FISABIO	Elche	Alicante
Spain	Universidad Miguel Hernández	Elche	Alicante

Sponsors (13)

Lead Sponsor

Collaborator

Universidad Miguel Hernandez de Elche

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

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Aranaz-Andrés JM, Aibar C, Limón 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. — View Citation

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. Review. — View Citation

Gibson R. The human cost of overuse. BMJ. 2014 May 6;348:g2975. doi: 10.1136/bmj.g2975. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: JAMA Intern Med. 2015 Dec;175(12):2003. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical overuse	Inadequate prescriptions of antimicrobials, mucolytics, lipid-lowering-drugs, ibuprofen or paracetamol in some specific cases defined as overuse	Three years
Primary	Medical overuse	Inadequate test for lumbalgia or prostate cancer	Three years
Secondary	Adverse events as consequence of inadequate clinical decision [Safety]	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