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

1 de junho de 2026 atualizado por: Ivan A. Huespe, Hospital Italiano de Buenos Aires

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

600

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina, B8000
        • Hospital Municipal de Agudos Dr. Leónidas Lucero
      • Isidro Casanova, Buenos Aires, Argentina, B1765
        • Hospital Interzonal General de Agudos Dr. Diego Paroissien
      • Pilar, Buenos Aires, Argentina, B1629WTA
        • Hospital Austral
      • San Justo, Buenos Aires, Argentina, 1754
        • Hospital Italiano de San Justo
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1407
        • Hospital General de Agudos Dalmacio Vélez Sarsfield
      • Buenos Aires, Buenos Aires F.D., Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Buenos Aires F.D., Argentina, C1425ASQ
        • Hospital Aleman
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5016KEH
        • Hospital Privado Universitario de Córdoba

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

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

Exclusion Criteria:

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Multicomponent Diagnostic Stewardship Intervention
Hospital 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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Monthly Laboratory Testing Intensity Using Standardized Biochemical Units per Occupied Bed-Day
Prazo: Baseline period (pre-implementation) and 8 months post-implementation follow-up, analyzed monthly.
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.
Baseline period (pre-implementation) and 8 months post-implementation follow-up, analyzed monthly.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Monthly In-Hospital Mortality Rate
Prazo: Baseline period and 8 months post-implementation follow-up, analyzed monthly.
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.
Baseline period and 8 months post-implementation follow-up, analyzed monthly.
Monthly Length of Stay
Prazo: Baseline period and 8 months post-implementation follow-up, analyzed monthly.
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.
Baseline period and 8 months post-implementation follow-up, analyzed monthly.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Implementation Outcomes (RE-AIM Framework)
Prazo: Implementation phase and 8 months post-implementation follow-up.
Implementation indicators mapped to the RE-AIM framework, including reach, adoption, implementation fidelity, and maintenance. Indicators will be summarized descriptively at the unit and center levels.
Implementation phase and 8 months post-implementation follow-up.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires
  • Cadeira de estudo: Javier A Pollán, PhD, Hospital Italiano de Buenos Aires

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2025

Conclusão Primária (Real)

31 de julho de 2025

Conclusão do estudo (Real)

31 de julho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de junho de 2026

Primeira postagem (Real)

5 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared. The study uses aggregated, anonymized unit-level data extracted from institutional systems.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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