跳至主要内容
临床试验/NCT04877535
NCT04877535已完成不适用

A Pilot Study for the Effect of Risk Prediction on Anticipatory Guidance and Team Coordination for Postoperative Care

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2021年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
1
主要终点
Overall Handoff Effectiveness

研究概览

简要总结

The objectives of the study are to determine the interpretability, workflow role, and effect on communications of showing report cards containing Machine Learning (ML)-based risk profiles based on pre- and intra-operative data to postoperative providers.

详细描述

Although surgery and anesthesia have become much safer on average, many patients still experience complications after surgery. Some of these complications are likely to be avoided or less severe with early detection and treatment. Barnes-Jewish Hospital has recently started using an Anesthesia Control Tower (ACT), which is a remote group lead by an anesthesiologist who reviews live data from BJH operating rooms and calls the anesthesia provider with concerns to improve reaction times and improve use of best-practices treatments. The ACT also uses machine learning (ML) to calculate patient risks during surgery as a way of measuring when the patient is doing better or worse.

The study team suspects that two mechanisms may allow risk prediction to improve postoperative care. First, is that it may make some data more actionable to clinicians. Although intraoperative data is extremely rich with many monitors, drug-response events, and surgical stress reactions to reveal the physiological state of the patient, that data is also extremely specialized and difficult to access. The study team thinks that many times the right interpretation of intraoperative data or the right treatment to give isn't clear until the surgery is nearly finished. The medical team in the recovery room (post-anesthesia care unit, PACU) and surgical wards is responsible for deciding the treatment strategy, but they don't have access to the information from the intraoperative monitors and events. Those providers also lack the familiarity to directly interpret that information and time to review it in detail. Even preoperative information may be less than fully available because the patient may still be too sedated or confused from the anesthesia to explain much about their history. By summarizing these diverse sources of information into a risk profile, machine learning outputs may directly improve the understanding of postoperative providers or improve the identification of patients at elevated risk for postoperative adverse outcomes.

A second mechanism derives from behavior changes which may occur in providers in reaction to machine-generated risk profiles. The study team has observed many handoffs from the operating room and PACU include lists of "important" data, but it is common for the handoff-giver to provide no interpretation (what problem is this information related to) or anticipatory guidance (having identified a potential or actual problem, what should the handoff receiver do). The study team has also observed than once a major risk has been clearly identified along the chain of handoff it tends to be propagated forward with connection to the underlying data, any changes noticed by the current provider, and the current plan. The study team suspects that in the subset of patients with substantially elevated predictions on their risk profile, handoff communication and team coordination for the identified problems may improve.

The larger goal is to deploy a "report card" for each patient that summarizes the preoperative assessment and intraoperative data in a way that is useful for postoperative providers. In this study these ML reports will be integrated into the clinical workflow and determine if it does affect handoff behavior. The study team will also evaluate the information-effect and test the report card for safety by determining if clinicians identify any major inaccuracies related to the implementation.

This study is a substudy of a randomized trial of ACT-intraoperative contact (TECTONICS IRB# 201903026), and only patients in the contact (treatment) group will be eligible. The screened patients will be all adults having surgery at BJH with the division of Acute and Critical Care Surgery. Exclusion criteria are a planned ICU admission. For each included patient, the ACT clinician will review the report card information, and the postoperative providers will either be directly contacted or receive an Epic Best Practices Advisory. Our study will be a before-after quasi-experiment, meaning that after a fixed date, all eligible patients will receive the intervention, and the outcome measures will be compared to patients before that date. The outcome measure we will study is handoff effectiveness from the recovery room to wards. Providers will be surveyed on information value, any inaccurate items, or major omissions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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
否

入选标准

  • •ODIN-Pilot will intervene on a subset of TECTONICS participants meeting all the following criteria:
  • •Within the TECTONICS contact arm (adults undergoing OR procedures)
  • •Operating room at BJH South campus (including all of "Pod 2", "Pod 3", "Pod 5") (excluding all procedure suites such as Interventional Radiology, Parkview Tower "Pod 1", Center for Advanced Medicine "Pod 4", Labor and Delivery suites)
  • •Surgeon is a member of the Acute and Critical Care Surgery division or the postoperative bed is 16300 observation unit.
  • •Planned non-ICU disposition ("floor" and "observation unit" collectively "ward" patients).

排除标准

  • •Not enrolled in TECTONICS Study
  • •Randomized to the observation arm in TECTONICS study
  • •Planned ICU admission
  • •Patients are only included once; if previously included a subsequent surgery is not eligible

研究组 & 干预措施

Stage 1: Usual Care

No Intervention

The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians.

Stage 2: Intervention

Experimental

ML will be used to create a report card for each patient that summarizes the preoperative assessment and intraoperative data. Report card data will be made available to providers through multiple methods: integration into electronic health records workflows, electronic health records notifications, mobile device notifications, and print outs in the paper chart

Patients who have a previous assignment (from another day) are not eligible.

干预措施: ML-based report card (Device)

Stage 2: Usual Care

No Intervention

The standard of care. The report card will be electronically generated (to determine eligibility) but it will not be visible to clinicians.

Patients who have a previous assignment (from another day) are not eligible.

结局指标

主要结局

Overall Handoff Effectiveness

时间窗: 8 hours postop

After handoff was completed, receiving nurses were asked: Globally, how effective was the handover 1. Not at all effective 2. Somewhat effective 3. Moderately effective 4. Very effective 5. Extremely effective The item is taken from PMID:25806398 but has no name

次要结局

  • Number of Participants With ML Topics Discussed During Handoff(8 hours postop)
  • Number of Handoff Receivers Agreeing That They Received All Needed Information(8 hours postop)
  • Number of Participants With Anticipatory Guidance During Handoff(8 hours postop)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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