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Набор по приглашению NCT07189364

Peer Comparison Feedback As An Antimicrobial Prescribing Intervention To General Medicine Specialists

Без фазы С лечением Antimicrobial Stewardship Antimicrobial Drug Resistance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer Comparison Feedback Report.
Кому может быть актуально
Состояния в реестре: Antimicrobial Stewardship, Antimicrobial Drug Resistance. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to evaluate the effect of a peer comparison feedback report, combined with a best practices toolkit, on the volume of antimicrobial use by general medicine physicians. The study also aims to understand the qualitative and quantitative impact of peer comparison feedback on antimicrobial prescribing in hospital. This study will leverage data from GEMINI, a hospital research collaborative that collects administrative and clinical data from 30+ Ontario hospitals, to create these peer comparison feedback reports.

Подробное описание

Antimicrobial resistance (AMR) is a critical threat to human health, having led to the deaths of 14,000 people in Canada in 2018 and 1.25 million people globally in 2019. There has been limited success in overcoming AMR through developing new antimicrobials, primarily due to inadequate investment in new antimicrobial discovery, and economic and regulatory hurdles. Acquired resistance is also likely to occur as newer agents come to market. The World Health Organization and the Public Health Agency of Canada have identified overuse of antimicrobials as a primary ongoing driver of AMR. Therefore, optimizing antimicrobial use must be a cornerstone of our response to the AMR crisis.

Antimicrobial stewardship (AMS) interventions (activities designed to safely improve antimicrobial use) can lead to reductions in antimicrobial use, antimicrobial costs, hospital length of stay, and C. difficile rates. Previous work has demonstrated that audit and feedback with peer comparison in a primary care setting can lead to a clinically significant reduction in antimicrobial use, with no demonstrable safety concerns. For example, the study team previously tested a peer comparison letter to primary care providers in the highest quartile of antimicrobial prescribing across Ontario and found a clinically significant 4% relative reduction in total antimicrobial prescribing. This extrapolates to nearly 150,000 fewer prescriptions and drug-cost savings of $2.7 million annually for the province.

General medicine wards are an important target for antimicrobial stewardship efforts, as they care for the largest group of hospital inpatients, patients are often medically complex, and admissions are heterogeneous in condition/disease. However, physician-level prescribing data for hospitalized patients has historically been difficult to collect and attribute to a specific clinician, limiting rigorous evaluation. This trial will leverage GEMINI's pharmacy data to create physician-level peer-comparison reports for physicians practicing on general medical wards. Building on a previous CIHR-funded RCT led by Drs. Desveaux and Ivers, this trial will also develop a mixed methods process evaluation methodology to assess fidelity and mechanism of action.

Вмешательства

  • Поведенческое Peer Comparison Feedback Report
    The intervention will be an electronic, individualized, peer-comparison feedback report on the participant's antimicrobial prescribing practices, combined with a knowledge toolkit focused on optimizing antimicrobial use.

Первичные конечные точки

  • Antimicrobial Days of Therapy (DOT)/100 days present [Срок оценки: The primary outcome will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
Вторичные конечные точки (11)
  • Initiation of antimicrobial therapy [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • Discontinuation of antimicrobial therapy within 72 hours [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • Antimicrobial-free days [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • Antimicrobial choice [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • Mechanism of action (interview) [Срок оценки: This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).]
  • Fidelity of receipt (survey) [Срок оценки: This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).]
  • Fidelity of implementation (survey) [Срок оценки: This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).]
  • In-hospital mortality [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • Readmission within 7 days [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • ICU admissions [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]
  • Inpatient LOS (length of stay) [Срок оценки: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).]

Критерии участия

Критерии включения

  • Patient-level: All adult inpatients (>=18 years of age) discharged within the baseline evaluation period and follow up period will be included in a physician report if they match the following criteria: a) Total in-hospital length of stay (LOS) is less than or equal to 14 days; b) and admitted to or discharged from a general medicine or hospitalist ward; c) admitted via the emergency department.
  • Physician-level: Physicians will be included if they have at least 50 hospitalizations attributed to them during the baseline period. Physicians who practice at multiple sites will only be included at the hospital with more encounters.
  • Hospital-level: In total, 29 teaching and community hospitals that provide data to GEMINI, with comprehensive geographic coverage of Ontario, will be included in this trial.

Критерии исключения

  • Patient-level: All data from ICU dates of care will be excluded from the trial (defined by ICU admission start and stop dates). All antimicrobial use data from ICU dates will be censored and excluded from attribution to GM physicians. Additionally, all patients with ICD-10-CA code Z51.5 for palliative care will be excluded owing to expected differences in antimicrobial management strategies.
  • Physician-level: No additional exclusion criteria will be used.
  • Hospital-level: Two hospitals in the GEMINI network will be excluded from this trial due to their lack of GM wards (a cancer hospital and a COVID-19 reactivation hospital). Additionally, any hospitals in the GEMINI network that do not meet annual data quality standards for antimicrobial use or other data fields will not be included in the trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Канада · 1 центр
  • GEMINI Research Program — Toronto

Идентификаторы

NCT: NCT07189364 · 5327

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗