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

NCT07629219 | Completed

• 1 other identifier: 15410
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Low-Value Care; Costs and Cost Analysis; Implementation Science; Public Health; Clinical Laboratory Techniques; Quaternary Prevention

Keywords

Quaternary Prevention; Low-Value Care; Costs and Cost Analysis; Implementation Science; Public Health; Clinical Laboratory Techniques

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Monthly In-Hospital Mortality Rate

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

• Monthly Length of Stay

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

Other Outcomes (1)

• Implementation Outcomes (RE-AIM Framework)

  Implementation phase and 8 months post-implementation follow-up.

Study Arms (1)

Multicomponent Diagnostic Stewardship Intervention

EXPERIMENTAL

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.

Behavioral: OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle

Interventions

OPTIMIZAR Multicomponent Diagnostic Stewardship Bundle BEHAVIORAL

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.

Multicomponent Diagnostic Stewardship Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (8)

Hospital Municipal de Agudos Dr. Leónidas Lucero

Bahía Blanca, Buenos Aires, B8000, Argentina

Location

Hospital Interzonal General de Agudos Dr. Diego Paroissien

Isidro Casanova, Buenos Aires, B1765, Argentina

Location

Hospital Austral

Pilar, Buenos Aires, B1629WTA, Argentina

Location

Hospital Italiano de San Justo

San Justo, Buenos Aires, 1754, Argentina

Location

Hospital General de Agudos Dalmacio Vélez Sarsfield

Buenos Aires, Buenos Aires F.D., 1407, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

Location

Hospital Alemán

Buenos Aires, Buenos Aires F.D., C1425ASQ, Argentina

Location

Hospital Privado Universitario de Córdoba

Córdoba, Córdoba Province, X5016KEH, Argentina

Location

Related Publications (17)

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  BACKGROUND

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Study Officials

• Iván A Huespe, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Javier A Pollán, PhD

  Hospital Italiano de Buenos Aires

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (8)