- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07629219
Optimization of Low-Value Medical Testing Practices in Hospitalized Patients in Argentina (OPTIMIZAR)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Buenos Aires
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Bahía Blanca, Buenos Aires, 아르헨티나, B8000
- Hospital Municipal de Agudos Dr. Leónidas Lucero
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Isidro Casanova, Buenos Aires, 아르헨티나, B1765
- Hospital Interzonal General de Agudos Dr. Diego Paroissien
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Pilar, Buenos Aires, 아르헨티나, B1629WTA
- Hospital Austral
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San Justo, Buenos Aires, 아르헨티나, 1754
- Hospital Italiano de San Justo
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., 아르헨티나, 1407
- Hospital General de Agudos Dalmacio Vélez Sarsfield
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Buenos Aires, Buenos Aires F.D., 아르헨티나, C1199ABB
- Hospital Italiano de Buenos Aires
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Buenos Aires, Buenos Aires F.D., 아르헨티나, C1425ASQ
- Hospital Aleman
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Córdoba Province
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Córdoba, Córdoba Province, 아르헨티나, X5016KEH
- Hospital Privado Universitario de Córdoba
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Monthly Laboratory Testing Intensity Using Standardized Biochemical Units per Occupied Bed-Day
기간: Baseline period (pre-implementation) and 8 months post-implementation follow-up, analyzed monthly.
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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.
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Baseline period (pre-implementation) and 8 months post-implementation follow-up, analyzed monthly.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Monthly In-Hospital Mortality Rate
기간: Baseline period and 8 months post-implementation follow-up, analyzed monthly.
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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.
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Baseline period and 8 months post-implementation follow-up, analyzed monthly.
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Monthly Length of Stay
기간: Baseline period and 8 months post-implementation follow-up, analyzed monthly.
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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.
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Baseline period and 8 months post-implementation follow-up, analyzed monthly.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Implementation Outcomes (RE-AIM Framework)
기간: Implementation phase and 8 months post-implementation follow-up.
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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.
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Implementation phase and 8 months post-implementation follow-up.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires
- 연구 의자: Javier A Pollán, PhD, Hospital Italiano de Buenos Aires
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- NBU Y ACTUALIZACIONES [Internet]. [cited 2026 Feb 3]. Available from: https://cubra.org.ar/anexo-nbu-2012-enero-2024/
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Kobewka DM, Ronksley PE, McKay JA, Forster AJ, van Walraven C. Influence of educational, audit and feedback, system based, and incentive and penalty interventions to reduce laboratory test utilization: a systematic review. Clin Chem Lab Med. 2015 Feb;53(2):157-83. doi: 10.1515/cclm-2014-0778.
- Hauser RG, Shirts BH. Do we now know what inappropriate laboratory utilization is? An expanded systematic review of laboratory clinical audits. Am J Clin Pathol. 2014 Jun;141(6):774-83. doi: 10.1309/AJCPX1HIEM4KLGNU.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 15410
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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