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临床试验/NCT05447806
NCT05447806招募中不适用

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

Milton S. Hershey Medical Center4 个研究点 分布在 1 个国家目标入组 15,732 人开始时间: 2022年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15,732
试验地点
4
主要终点
Average hospital length of stay (LOS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The study is single-blinded. Participants will be masked from the intervention due to the GlucAlert CDS tool only being viewed by physicians. Investigators will remain unblinded and know when the tool is turned "On" or "Off." The outcomes statisticians and assessors will analyze deidentified data and remain blinded for their analysis.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Children (<18 years)

研究组 & 干预措施

Active Inpatient Diabetes Clinical Decision Support

Experimental

The Active arm consists of participants treated during the "ON" phase of the GlucAlert-CDS tool. The tool operates through an automated process of rules embedded in the EMR recognizing hypoglycemia (established or impending); recurrent hyperglycemia (in type 1 and 2 DM, or stress hyperglycemia-SH); and inappropriate insulin use (sliding scales monotherapy if recurrent hyperglycemia in type 2 DM or SH, or any time in type 1 DM). If the tool's criteria are met, an alert in the EMR will notify the provider with the clinically recommended treatment.

干预措施: Active Electronic Medical Record Inpatient Diabetes Clinical Decision Support (Device)

Inactive Inpatient Diabetes Clinical Decision Support

No Intervention

The Inactive arm consists of participants treated during the "OFF" phase of the GlucAlert-CDS Tool. Alerts will not be sent to provider's

结局指标

主要结局

Average hospital length of stay (LOS)

时间窗: Duration of hospital admission, up to 6 weeks

Number of days in the hospital

次要结局

  • Proportion of gap in care events(Duration of hospital admission, up to 3 months)
  • Glycemic control parameters - average glucose per day per admission(Duration of hospital admission, up to 3 months)
  • Frequency of utilization of consulting services resource(Duration of hospital admission, up to 3 months)
  • Glycemic control parameters - average glucose per admission(Duration of hospital admission, up to 3 months)
  • Incidence of post-discharge mortality(Up to 3 months after discharge)
  • Glycemic control parameters - glycemic variability(Duration of hospital admission, up to 3 months)
  • Incidence of inpatient mortality(Duration of hospital admission, up to 3 months)
  • Proportion of diabetes medication optimization at the transition of care(Duration of hospital admission, up to 3 months)
  • Average reduction of glycohemoglobin level within 12 months of discharge(up to 12 months after being discharged from the hospital)
  • Frequency of Intensive Care unit (ICU) transfers(Duration of hospital admission, up to 3 months)
  • Cost of hospitalization(Duration of hospital admission, up to 3 months)
  • Frequency of post-hospitalization skilled care needed(Duration of hospital admission, up to 3 months)
  • Frequency of severity of illness(Duration of hospital admission, up to 3 months)
  • Frequency of hospital readmission(Up to 30 days after being discharged from the hospital)
  • Frequency of post-hospitalization skilled care needed from home to more advanced care(Duration of hospital admission, up to 3 months)
  • Hospital revenue(Duration of hospital admission, up to 3 months)
  • Proportion of surgical complications(Duration of hospital admission, up to 3 months)
  • Proportion of medical complications(Duration of hospital admission, up to 3 months)
  • Proportion of hospital-acquired infections(Duration of hospital admission, up to 3 months)
  • Proportion of safety events(Duration of hospital admission, up to 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ariana Pichardo-Lowden

Professor, Department of Medicine

Milton S. Hershey Medical Center

研究点 (4)

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