AzTrials
AzTrials

Low-Value CareOPTIMIZARNCT07629219

Optimization of Low-Value Medical Testing Practices in Hospitalized Patients in Argentina

A study testing OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle in people with Low-Value Care and Costs and Cost Analysis, run by Hospital Italiano de Buenos Aires at 8 sites in Argentina.

Completed

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

Official record
Search all trials

Trial summary

Overuse of laboratory testing in hospitalized patients is a common form of low-value care and may contribute to patient discomfort, unnecessary downstream testing, inefficient use of healthcare resources, and increased costs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
8 sitesArgentina
Study dates
1 Jun 2025to 31 Jul 2025
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (≥18 years) hospitalized in participating internal medicine wards or intensive care units during the study period.

Who cannot join

  • None at the individual level. The intervention is implemented at the unit level and applies to all admitted adult patients during the study period.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Argentina8 sites
  • Hospital Municipal de Agudos Dr. Leónidas Lucero

    Bahía Blanca, Buenos Aires, B8000

  • Hospital General de Agudos Dalmacio Vélez Sarsfield

    Buenos Aires, Buenos Aires F.D., 1407

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Buenos Aires F.D., C1199ABB

  • Hospital Alemán

    Buenos Aires, Buenos Aires F.D., C1425ASQ

  • Hospital Privado Universitario de Córdoba

    Córdoba, Córdoba Province, X5016KEH

  • Hospital Interzonal General de Agudos Dr. Diego Paroissien

    Isidro Casanova, Buenos Aires, B1765

  • Hospital Austral

    Pilar, Buenos Aires, B1629WTA

  • Hospital Italiano de San Justo

    San Justo, Buenos Aires, 1754

Other trials in Argentina

About this study

Official title: Optimization of Low-Value Medical Testing Practices in Hospitalized Patients in Argentina (OPTIMIZAR)

Overuse of laboratory testing in hospitalized patients is a common form of low-value care and may contribute to patient discomfort, unnecessary downstream testing, inefficient use of healthcare resources, and increased costs. Although diagnostic stewardship interventions have reduced unnecessary laboratory testing in several high-income settings, evidence from Latin America remains limited, particularly regarding implementation processes and sustainability.

OPTIMIZAR is a multicenter, effectiveness-implementation hybrid type 2 study evaluating a multicomponent diagnostic stewardship intervention in internal medicine wards and intensive care units across public and private tertiary hospitals in Argentina. The intervention targets laboratory ordering practices through workflow redesign, operational support, clinician education, and audit and feedback, with local leadership teams supporting implementation at each site.

Effectiveness will be evaluated using an interrupted time series design with aggregated unit-level data collected before and after implementation. The primary outcome is monthly laboratory testing intensity, measured as Argentine Standardized Biochemical Units per occupied bed-day. Secondary outcomes include in-hospital mortality and hospital length of stay. Implementation outcomes will be assessed descriptively using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework.

Read the detailed description

The overuse of diagnostic laboratory testing in hospitalized patients is a well-recognized source of low-value care. Unnecessary testing may contribute to patient discomfort, iatrogenic anemia, false-positive findings, diagnostic cascades, prolonged hospitalization, increased workload for clinical teams, and inefficient use of healthcare resources. Diagnostic stewardship strategies have been proposed to improve the appropriateness of test ordering while maintaining patient safety. However, most available evidence comes from high-income healthcare systems, and there is limited evidence regarding the effectiveness, implementation, and sustainability of these interventions in Latin American hospitals.

OPTIMIZAR is a multicenter, effectiveness-implementation hybrid type 2 study designed to evaluate both the effectiveness and implementation of a multicomponent diagnostic stewardship intervention. The study will be conducted in internal medicine wards and intensive care units across public and private tertiary hospitals in Argentina. The intervention is implemented at the hospital unit level and is integrated into routine clinical practice.

The intervention consists of a multifaceted diagnostic stewardship bundle targeting laboratory ordering practices. Its components include: workflow redesign to define clear responsibility for daily laboratory ordering; operational support strategies such as sample reutilization for add-on testing and remote electronic order modification; structured educational sessions focused on diagnostic stewardship principles, healthcare costs, and the clinical utility of commonly ordered laboratory tests; and audit and feedback with periodic review of laboratory ordering patterns and structured feedback to clinical teams. Each participating site will establish a local leadership team responsible for contextual adaptation, stakeholder engagement, and implementation support.

Effectiveness will be assessed using an interrupted time series design with aggregated unit-level data collected during a baseline usual-care period and after implementation. The primary outcome is monthly laboratory testing intensity, measured as Argentine Standardized Biochemical Units per occupied bed-day. This metric is based on the Argentine laboratory billing and weighting system, which assigns standardized biochemical units according to the technical complexity and resource utilization of each laboratory test. The outcome will be calculated monthly for each participating unit as the total number of standardized biochemical units divided by the total number of occupied bed-days.

Secondary effectiveness outcomes include monthly in-hospital mortality and hospital length of stay. These outcomes will be evaluated to assess whether reductions in laboratory testing are achieved without evidence of patient harm. Interrupted time series models will be used to estimate baseline trends, immediate changes after implementation, and post-intervention changes in trend.

Implementation outcomes will be assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. These indicators will include the extent to which participating units and clinicians are exposed to the intervention, adoption of intervention components, fidelity to the planned implementation strategy, barriers and facilitators to implementation, and maintenance of the intervention over time. This study aims to generate evidence on whether a locally adapted diagnostic stewardship strategy can safely reduce low-value laboratory testing and be implemented sustainably in Argentine hospital settings.

Being tested
OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle
Keywords
Quaternary Prevention, Low-Value Care, Costs and Cost Analysis, Implementation Science, Public Health, Clinical Laboratory Techniques

What participants receive

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

  • OPTIMIZAR Multicomponent Diagnostic Stewardship BundleBehavioural

    A multifaceted diagnostic stewardship intervention targeting laboratory ordering practices. Components include: (1) decision-making workflow redesign with designated responsibility for daily laboratory ordering; (2) operational support strategies such as sample reutilization ("add-on" testing) and remote electronic order modification; (3) structured educational sessions on diagnostic stewardship principles, costs, and clinical utility of commonly ordered tests; and (4) audit and feedback with biweekly review of laboratory orders and structured feedback to clinical teams. The intervention is implemented at the hospital unit level and integrated into routine clinical processes.

Study groups in NCT07629219
Study groupRoleWhat they receive
Multicomponent Diagnostic Stewardship InterventionExperimentalHospital units receive a multicomponent diagnostic stewardship intervention after a baseline usual-care period. The intervention targets laboratory ordering practices at the unit level. Outcomes are evaluated using an interrupted time series design comparing pre- and post-implementation periods.
Receives: Behavioral: OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle

What is being measured

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

  1. Monthly Laboratory Testing Intensity Using Standardized Biochemical Units per Occupied Bed-Day

    Monthly rate of laboratory utilization standardized as Argentine Standardized Biochemical Units (NBU) per occupied bed-day at the hospital unit level. NBU refers to the Argentine laboratory billing and weighting system that assigns standardized biochemical units according to the technical complexity and resource utilization of each laboratory test. The outcome will be calculated as total monthly NBU units divided by total occupied bed-days for each unit-month. The interrupted time series model will estimate the pre-intervention trend, the immediate level change at intervention onset, and the post-intervention slope change.

    Measured: Baseline period (pre-implementation) and 8 months post-implementation follow-up, analyzed monthly.

Secondary outcomes (2)
  1. Monthly In-Hospital Mortality Rate

    Monthly in-hospital mortality rate at the hospital unit level, calculated using aggregated administrative and clinical data. Monthly admissions will be used as denominator. Interrupted time series analysis will assess level and slope changes following intervention implementation.

    Measured: Baseline period and 8 months post-implementation follow-up, analyzed monthly.

  2. Monthly Length of Stay

    Monthly average (or median, if highly skewed) hospital length of stay at the unit level, derived from administrative and clinical databases. Interrupted time series analysis will evaluate pre- and post-intervention changes.

    Measured: Baseline period and 8 months post-implementation follow-up, analyzed monthly.

Timeline

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

  1. First posted5 Jun 2026
  2. Study start1 Jun 2025
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Single-group assignment with a pre-post design using an interrupted time series approach. All participating units receive the multicomponent intervention simultaneously after a baseline usual-care period. Outcomes are measured at the unit level before and after implementation to evaluate changes in laboratory testing intensity and safety outcomes over time.
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07629219
Sponsor's protocol ID
15410
Acronym
OPTIMIZAR
Status last verified
Jun 2026
First submitted
19 May 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. The study uses aggregated, anonymized unit-level data extracted from institutional systems.

Publications

  • Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

    PubMed 10474547
  • NBU Y ACTUALIZACIONES [Internet]. [cited 2026 Feb 3]. Available from: https://cubra.org.ar/anexo-nbu-2012-enero-2024/

  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PubMed 21513547
  • Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A, Taylor SJ; StaRI Group. Standards for Reporting Implementation Studies (StaRI) Statement. BMJ. 2017 Mar 6;356:i6795. doi: 10.1136/bmj.i6795.

    PubMed 28264797
  • Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019 Oct;280:112513. doi: 10.1016/j.psychres.2019.112513. Epub 2019 Aug 9.

    PubMed 31434011
  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PubMed 22310560
  • Kopitowski K. Lanzamiento de la campaña Choosing Wisely Argentina: primeros pasos hacia la desimplementación de prácticas de bajo valor. Evidencia actualizacion en la práctica ambulatoria. 2024 Jan 24;27(1):e007110-e007110.

  • Bindraban RS, van Beneden M, Kramer MHH, van Solinge WW, van de Ven PM, Naaktgeboren CA, Al-Dulaimy M, van der Wekken LC, Bandt YC, Stam F, Neppelenbroek SIM, Griffioen-Keijzer A, Castelijn DAR, Wevers BA, Boerman AW, van Wijnen M, Ten Berg MJ, Nanayakkara PWB. Association of a Multifaceted Intervention With Ordering of Unnecessary Laboratory Tests Among Caregivers in Internal Medicine Departments. JAMA Netw Open. 2019 Jul 3;2(7):e197577. doi: 10.1001/jamanetworkopen.2019.7577.

    PubMed 31339544
  • Website [Internet]. Available from: https://www.nice.org.uk/sharedlearning/nice-do-not-do-prompts.

  • Devis L, Catry E, Honore PM, Mansour A, Lippi G, Mullier F, Closset M. Interventions to improve appropriateness of laboratory testing in the intensive care unit: a narrative review. Ann Intensive Care. 2024 Jan 15;14(1):9. doi: 10.1186/s13613-024-01244-y.

    PubMed 38224401
  • Vegting IL, van Beneden M, Kramer MH, Thijs A, Kostense PJ, Nanayakkara PW. How to save costs by reducing unnecessary testing: lean thinking in clinical practice. Eur J Intern Med. 2012 Jan;23(1):70-5. doi: 10.1016/j.ejim.2011.07.003. Epub 2011 Aug 2.

    PubMed 22153535
  • Muskens JLJM, Kool RB, van Dulmen SA, Westert GP. Overuse of diagnostic testing in healthcare: a systematic review. BMJ Qual Saf. 2022 Jan;31(1):54-63. doi: 10.1136/bmjqs-2020-012576. Epub 2021 May 10.

    PubMed 33972387
  • Pageler NM, Franzon D, Longhurst CA, Wood M, Shin AY, Adams ES, Widen E, Cornfield DN. Embedding time-limited laboratory orders within computerized provider order entry reduces laboratory utilization. Pediatr Crit Care Med. 2013 May;14(4):413-9. doi: 10.1097/PCC.0b013e318272010c.

    PubMed 23439456
  • Zhi M, Ding EL, Theisen-Toupal J, Whelan J, Arnaout R. The landscape of inappropriate laboratory testing: a 15-year meta-analysis. PLoS One. 2013 Nov 15;8(11):e78962. doi: 10.1371/journal.pone.0078962. eCollection 2013.

    PubMed 24260139
  • Bindraban RS, Ten Berg MJ, Naaktgeboren CA, Kramer MHH, Van Solinge WW, Nanayakkara PWB. Reducing Test Utilization in Hospital Settings: A Narrative Review. Ann Lab Med. 2018 Sep;38(5):402-412. doi: 10.3343/alm.2018.38.5.402.

    PubMed 29797809

Questions about this trial

What is this clinical trial studying?

A study testing OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle in people with Low-Value Care and Costs and Cost Analysis, run by Hospital Italiano de Buenos Aires at 8 sites in Argentina.

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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Argentina. 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?

Monthly Laboratory Testing Intensity Using Standardized Biochemical Units per Occupied Bed-Day (time frame: Baseline period (pre-implementation) and 8 months post-implementation follow-up, analyzed monthly.). 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 NCT07629219, which also lists 17 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 5 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in