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Идёт набор NCT05447806

Diabetes Clinical Decision Support

Без фазы С лечением Hyperglycemia Hyperglycemia Stress Diabetes PreDiabetes

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: Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support.
Кому может быть актуально
Состояния в реестре: Hyperglycemia, Hyperglycemia Stress, Diabetes, PreDiabetes. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Glucose Management Clinical Decision Support to Improve Outcomes in Academic and Community Hospitals

Обзор

The purpose of this study is to determine the impact of an electronic medical record clinical decision support tool on rates of dysglycemia in the hospital, and its clinical and economical outcomes. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.

Подробное описание

Approximately 9 million patients with diabetes (DM) are hospitalized annually and over 30% of inpatients without DM experience high glucose (HG) due to their acute illness. HG increases the risk of infectious and non- infectious complications and death, hospital length of stay (LOS), utilization of hospital resources and overall healthcare costs. While glucose control reduces these risks, controlling HG in the hospital is difficult due to multiple barriers such as recognizing and proactively treating glucose abnormalities, and adequately ordering insulin to treat HG in the hospital. Clinical decision support (CDS) is a system that uses computerized person- specific data in the electronic medical record (EMR) proven to improve hospital care. Among the various modalities, alert-CDS is shown to improve care delivery, providers' proactivity, and glucose control specifically in intensive care settings of academic institutions. However, alert-CDS has not yet been studied outside of intensive care units (ICU), or in community hospitals where most patients receive care. Furthermore, its impact on patients' outcomes has not been tested in any setting. The proposed project uses an innovative alert-CDS tool the investigators developed and validated which automatically identifies dysglycemia and inadequacies in insulin administration in the hospital. It alerts clinicians with recommendations to support decision making without superseding their clinical judgement. In the pilot study, it was found that this alert-CDS tool reduced recurrent high glucose levels and shortened LOS. Based on this promising preliminary data, in this project the investigators propose to study the impact of our CDS tool on clinical, economic and providers' performance outcomes among non-intensive care patients both in academic and community hospitals. This resource will be available intermittently in the EMR every 3 months for 36 months, thus allowing the comparison of 18 months of intervention and 18 months of standard care. Based on the pilot study, a sample size of 12,560 subjects will give an 80% power of detecting 0.34 days (\~ 8 hours) difference in length of stay, the primary endpoint of our study. The investigators propose the following aims: Aim 1) To determine the impact of the alert-CDS over conventional care on the clinical outcomes of non-ICU patients in an academic and four community hospitals. Aim 2) To determine the impact of the alert-CDS over conventional care on the economic outcomes of non-ICU patients in an academic and four community hospital. Aim 3) To determine the impact of alert-CDS for inpatient glycemic control on providers' perspectives, competencies and practice performance between an academic and four community hospital. The study received an IRB waiver of consent for the inclusion of subjects identified in the electronic health record. The consent of clinicians participating in study surveys is implied by agreeing to respond to surveys. It is hypothesized that the tool will increase providers' knowledge and decision making to manage dysglycemia allowing them to make better decisions about insulin administration. It is also hypothesized that clinical and economic outcomes will be better during the time alert-CDS is available. The anticipated success of our study builds upon a well-established multidisciplinary team of investigators strongly supported by leadership stakeholders in hospitals within a health system. The proposed study has the potential of establishing a new paradigm in the management of dysglycemia in hospitalized patients with a major positive impact on clinical and economic outcomes.

Вмешательства

  • Устройство Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support
    This prospective intervention will be carried out over 36 months and encompass 12 alternating GlucAlert-CDS phases lasting 3 months each. Six active phases (ON period) and six inactive phases (OFF period) will represent 18 months of intervention and control respectively. GlucAlert-CDS recognizes gaps in care denoting the automatic process of subjects' identification and inclusion. During the ON period, gap in care events detected in patients' EMR will evoke alert messages and care recommendation

Первичные конечные точки

  • Average hospital length of stay (LOS) [Срок оценки: Duration of hospital admission, up to 3 months]
Вторичные конечные точки (12)
  • Proportion of gap in care events [Срок оценки: Duration of hospital admission, up to 3 months]
  • Glycemic control parameters - Glucose metrics [Срок оценки: Duration of hospital admission, up to 3 months]
  • Glycemic control parameters - average glucose per day per admission [Срок оценки: Duration of hospital admission, up to 3 months]
  • Glycemic control parameters - glycemic variability [Срок оценки: Duration of hospital admission, up to 3 months]
  • Incidence of inpatient mortality [Срок оценки: Duration of hospital admission, up to 3 months]
  • Incidence of post-discharge mortality [Срок оценки: Up to 3 months after discharge]
  • Proportion of hospital-acquired infections [Срок оценки: Duration of hospital admission, up to 3 months]
  • Proportion of surgical complications [Срок оценки: Duration of hospital admission, up to 3 months]
  • Proportion of medical complications [Срок оценки: Duration of hospital admission, up to 3 months]
  • Proportion of safety events [Срок оценки: Duration of hospital admission, up to 3 months]
  • Frequency of severity of illness [Срок оценки: Duration of hospital admission, up to 3 months]
  • Proportion of diabetes medication optimization at the transition of care [Срок оценки: Duration of hospital admission, up to 3 months]

Критерии участия

Критерии включения

  • Hospitalized adult (>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, Holy Spirit Medical Center, and Lancaster Medical Center
  • Ambulatory adult (>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, Holy Spirit Medical Center, and Lancaster Medical Center
  • Trigger of an alert or a disease management message

Критерии исключения

  • Children (<18 years)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 2 центра
  • Penn State Hershey Medical Center — Hershey
  • Penn State Health St. Joseph Medical Center — Reading

Идентификаторы

NCT: NCT05447806 · STUDY00012931/20607 · 1R01DK130992-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗