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OverdoseSOBRINANCT03482232

Consequences of Doing What Should Not be Done in Primary Care

An observational study of Overdose and Adverse Event, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Overdose, Adverse Event
What is being tested?
Benzodiazepines, Non-steroidal anti-inflammatory drugs and paracetamol
Type of treatment
Surgery or procedure
How many people
750,000 participants
Where
2 sitesSpain
Study dates
14 Oct 2018to 10 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • All patients visiting GPs

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • FISABIO

    Elche, Alicante, 03202

  • Universidad Miguel Hernández

    Elche, Alicante, 03202

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Benzodiazepines, Non-steroidal anti-inflammatory drugs, paracetamol, Antimicrobial agent, Lipid-lowering drug
Keywords
patient safety, quality assurance, overuse
Medical subject headings
Drug Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenzodiazepinesDrug

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

  • Non-steroidal anti-inflammatory drugsDrug

    Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis

  • paracetamolDrug

    paracetamol 1g for more than 3 days

  • Antimicrobial agentDrug

    Also called Antibiotics

    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 drugDrug

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

  • Prostate cancerDiagnostic test

    Screening for prostate cancer in asymptomatic patients

  • LumbagoRadiation

    image tests in non-specific lumbago

  • Antimicrobial agentDrug

    Also called Antibiotics

    antibiotics for pharyngitis (infants)

  • MucolyticDrug

    Also called Mucolytics

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

  • Ibuprofen and paracetamolDrug

    treatment with ibuprofen and paracetamol (infants)

Study groups in NCT03482232
Study groupRoleWhat they receive
Patients visiting GPAll patients visiting GP. The frequency of some drugs and diagnosis tests include in the Do-Not-Do recommendations will be analyzed.
Receives: 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 pediatriciansAll 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.
Receives: Drug: Antimicrobial agent; Drug: Mucolytic; Drug: Ibuprofen and paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical overuse

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

    Measured: Three years

  2. Medical overuse

    Inadequate test for lumbalgia or prostate cancer

    Measured: Three years

Secondary outcomes (1)

  1. 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

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start14 Oct 2018
  3. Primary completion5 Dec 2019
  4. Study completion10 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
750,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482232
Sponsor's protocol ID
PI16/00816
Acronym
SOBRINA
Status last verified
Apr 2020
First submitted
16 Mar 2018
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Public and safety patient researchers

Publications

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

    PubMed 24803401

  • 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.

    PubMed 28077234

  • 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.

    PubMed 24374418

  • 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.

    PubMed 26457643

  • 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.

    PubMed 20458080

  • 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.

    PubMed 23180803

  • 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.

    PubMed 26258406

  • 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.

    PubMed 34009877

  • 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.

    PubMed 30837247

Questions about this trial

What is this clinical trial studying?

An observational study of Overdose and Adverse Event, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medical overuse (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03482232, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

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