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临床试验/NCT03911687
NCT03911687已完成不适用

Communicating Narrative Concerns Entered by RNs (CONCERN) Clinical Decision Support (CDS) System

Columbia University6 个研究点 分布在 1 个国家目标入组 60,893 人开始时间: 2020年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60,893
试验地点
6
主要终点
In-hospital Mortalities

研究概览

简要总结

There are patients who die or have a bad outcome in the hospital and this could be prevented. Data in the nurses' notes could be used by computers to tell the rest of the care team that a patient is not doing well and that they should act more quickly. This project will build and evaluate a computer system that makes it easier for the care team to see and understand that data and act quickly to save patients. The aims of this study is to answer the questions, what is the level of provider use of the CONCERN CDS notification system (called CONCERN SMARTapp) and resulting impact on selected patient outcomes? Specifically, the study has 1) validated desired thresholds for the CONCERN CDS system and 2) integrated the CONCERN CDS system for early warning of risky patient states within CDS tools.

In this portion of the study (aim 3), the investigator will implement and evaluate the CONCERN CDS system on primary outcomes of in-hospital mortality and length of stay and secondary outcomes of cardiac arrest, unanticipated transfers to the intensive care unit, and 30-day hospital readmission rates.

详细描述

Annually, more than 200,000 patients die in U.S. hospitals from cardiac arrest and over 130,000 patients inpatients deaths are attributed to sepsis. These deaths are preventable if patients who are at risk are detected earlier. Prior work found that nursing documentation within electronic health records (EHRs) contains information that could contribute to early detection and treatment, but these data are not being analyzed and exposed by EHRs to clinicians to initiate interventions quickly enough to save patients. A new source of predictive data is defined by analyzing the frequency and types of nursing documentation that indicated nurses' increased surveillance and level of concern for a patient. These data documented in the 48 hours preceding a cardiac arrest and hospital mortality were predictive of the event. While clinicians strive to provide the best care, there is a systematic problem within hospital settings of non-optimal communication between nurses and doctors leading to delays in care for patient at risk. Well-designed and tested EHRs are able to trend data and support communication and decision making, but too often fall short of these goals and actually increase clinician cognitive load through fragmented information displays, "note bloat", and information overload. Substitutable Medical Applications & Reusable Technologies (SMARTapps) using Fast Health Interoperability Resource (FHIR) standard allow for open sharing and use of innovations across EHR systems. The aim of this project is to design and evaluate a SMARTapp on FHIR used across two large academic medical centers that exposes to physicians and nurses our new predictive data source from nursing documentation to increase care team situational awareness of at risk patients to decrease preventable adverse outcomes.

Communicating Narrative Concerns Entered by RNs (CONCERN) Clinical Decision Support (CDS) system is the application being designed and evaluated. CONCERN Intervention Trial Design will be a multiple time-series intervention. Baseline data will be collected at all study sites. Silent release mode (no SMARTapp notification) will be used in non-equivalent control units and as a post-intervention unit control to evaluate if notifying clinicians can decrease rates of length of stay on non-ICU units and rates of 30-day hospital readmissions. Different versions of the CDS system (SMARTapp) will be incorporated for dynamic, adaptive functionality and determine if the pattern of nursing documentation has changed. A "burn-in" phase is built in to evaluate adoption and adaptation to the algorithm and phases for deployment of the silent release mode within the multiple time-series intervention trial for a total of 18 months of data collection, including pre-intervention data collection and silent release modes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

In-hospital Mortalities

时间窗: Up to 24 months

Number of patient deaths occurring in the hospital.

Average Length of Hospital Stay

时间窗: Up to 24 months

The number of days that a patient was in the hospital

次要结局

  • Number of Cardiac Arrests(Up to 24 months)
  • Number of Hospital Acquired Sepsis(Up to 24 months)
  • Number of Unanticipated Transfers to ICU(Up to 24 months)
  • Number of Hospital Readmissions(Up to 24 months)

研究者

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

Sarah Collins Rossetti

Assistant Professor of Biomedical Informatics and Nursing

Columbia University

研究点 (6)

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