Clinical trial NCT03482232: Consequences of Doing What Should Not be Done in Primary Care
Official title: Consequences of Doing What Should Not be Done in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overdose
Adverse Event
Keywords: patient safety
quality assurance
overuse
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Osasunbidea
name: Servicio Madrileño de Salud, Madrid, Spain
name: Fondo de Investigacion Sanitaria
name: AQuAS
name: Agencia de Calidad Sanitaria de Andalucía
name: Ministerio de Sanidad, Servicios Sociales e Igualdad
name: Servicio Aragones De Salud
name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
name: Generalitat Valenciana
name: MurciaSalud
name: Osakidetza
name: Castilla-La Mancha Health Service
First posted: 2018-03-29
Enrollment: 750000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients data codified in the primary care databases (BDCAP and BIFAP)

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.

Eligibility criteria: Inclusion Criteria:

* All patients visiting GPs

Exclusion Criteria:

* None

Primary outcomes:
measure: Medical overuse
timeFrame: Three years
measure: Medical overuse
timeFrame: Three years
Secondary outcomes:
measure: Adverse events as consequence of inadequate clinical decision [Safety]
timeFrame: Three years
Other outcomes:
Locations:
city: Elche
country: Spain
facility: FISABIO
state: Alicante
city: Elche
country: Spain
facility: Universidad Miguel Hernández
state: Alicante
Study officials:
affiliation: UNIVERSIDAD MIGUEL HERNANDEZ
name: JOSE J MIRA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibson R. The human cost of overuse. BMJ. 2014 May 6;348:g2975. doi: 10.1136/bmj.g2975. No abstract available.
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.
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.
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.
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. No abstract available.
citation: 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.
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. No abstract available.
citation: 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.
citation: 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.