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Using a Remote Patient Monitoring Alert System to Improve Care

2019年10月29日 更新者:Aalok Agarwala、Massachusetts General Hospital

Using a Remote Patient Monitoring Alert System to Improve Care in Geriatric Orthopedic Trauma Patients

The purpose of this study is to determine the efficacy of a remote patient monitoring platform and alert system in reducing adverse events for hospitalized geriatric orthopedic trauma patients.

調査の概要

詳細な説明

Geriatric orthopedic trauma patients are a particularly vulnerable cohort due to their age and medical complexity. These patients are often admitted to a floor unit with high physician-to-patient and nurse-to-patient ratios, especially during hours of low staffing intensity (eg, nighttime and weekend hours). As a result, during hours of low staffing intensity the potential for acute deterioration with delayed reaction from the care team is significant. The investigators aim to test the efficacy of a remote patient monitoring platform to reduce adverse events in this population during hours of low staffing intensity. The platform is a software called AlertWatch. It takes laboratory and vital sign data that has been reported in the medical record and determines whether it meets a cut-off value that is concerning for patient deterioration. If the value meets that cut-off, it sends a page to a recipient clinician. The investigators will have a physician trained in intensive care receive these alerts and respond to them by evaluating the patient and, in a consultative capacity, assist the primary team, namely the orthopedic surgery service, in taking care of the patient.

Patients will be randomized to intervention and control arms at the outset of their hospitalization. Patients in the intervention arm will receive standard of care monitoring and the primary team responsible for the care of the patient will remain the orthopedic surgery service, however, in addition, the AlertWatch software will be implemented and the intensive care physician will be involved in the patient's care when there is an alert. Patients in the control arm will receive standard of care monitoring and the orthopedic surgery service will be the primary team responsible. The Investigators will measure whether the intervention reduces adverse events in the study population compared with control patients.

All patients will be enrolled consecutively at the time of admission to the hospital. The AlertWatch platform (510(k) FDA clearance K15335) has the ability to automatically detect whether a patient admitted to a bed on the orthopedic surgery service meets inclusion criteria. The platform will automatically randomize patients into the active arm or the control arm of the study. For patients randomized to the active arm, the platform will provide alert monitoring.

The Investigators will also be enrolling intensive care physicians to participate in this study. Physician participation is optional. In advance of the start of the study, they will be provided information regarding the study and an informed consent document.

The AlertWatch platform has the ability to send an alert when it detects abnormalities, particular trends, or combinations of abnormalities or trends. In this study, the Investigators will use specific threshold values to alert for abnormalities and concerning trends in patient data. When an alert is made, it will be sent to the in-house intensive care physician's regular pager. The page will display the data. Orthopedic interns will continue to monitor for patient data in the standard fashion.

The Investigators will institute a protocol in which an intensive care physician is receiving alerts from AlertWatch during nighttime and weekend hours. The intensivist will: 1.) view the alert, 2.) determine whether any subsequent action is warranted. Subsequent actions may include: 1.) reviewing the patient's chart 2.) visiting the patient and/or his/her nurse 3.) paging the orthopedic surgery team to discuss the patient's situation.

There is an extremely low risk that a patient's safety would be at all threatened in either arm of the study. Patients who are assigned to the intervention arm and the control arm will both receive the standard of care. Intervention arm patients will additionally have the AlertWatch software relaying alerts to designated providers. The software does not create new, previously non-existent data. It relays data that is already available and viewable by all providers in the medical record for the patient. Given the nature of the intervention in this study, the likelihood of any adverse events due to the intervention is extremely low.

研究の種類

介入

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Admitted to Massachusetts General Hospital or Brigham and Women's Hospital
  • Admitted to orthopedic trauma surgery service
  • Admitted to a non-ICU bed (patients initially admitted to an ICU and then transferred to the non-ICU bed will be included)

Exclusion Criteria:

  • Admitted to service other than orthopedic trauma surgery

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:AlertWatch
Patients will receive standard monitoring and in addition the AlertWatch software will alert the intensive care physician if there is a value that meets criteria for alerting. The care team will be the orthopedic surgery team in addition to the intensive care physician being involved as a consultant if he/she receives an alert.
AlertWatch holds 510(k) FDA clearance K15335. It is a software program that takes data present in the medical record, including vital signs and laboratory results, and determines whether it meets predetermined thresholds for alerting a clinician. These thresholds are intended to correlate with signs of acute clinical deterioration in the patient being monitored.
介入なし:No AlertWatch
Patients will receive standard monitoring without the AlertWatch software. The care team will be the orthopedic surgery team without the intensive care physician being involved as a consultant.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mortality
時間枠:One year
Whether a patient experiences death during their hospitalization.
One year
Transfer to the ICU
時間枠:One year
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
One year
Cardiac arrest
時間枠:One year
Whether the patient experiences a cardiac arrest during their hospitalization.
One year
Rapid response team called
時間枠:One year
Whether the a rapid response team is called to assess the patient during their hospitalization.
One year

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to ordering of blood
時間枠:One year
Time from hemoglobin < 7 to when blood product is ordered for patient during their hospitalization.
One year
Time to ordering of fluids or vasopressors
時間枠:One year
Time from systolic blood pressure<80, diastolic<40 to when fluids or vasopressors are ordered for patient during their hospitalization.
One year
Time to ordering of diuretics, NIPPV, or intubation
時間枠:One year
Time from oxygen saturation<90% to when diuretics, NIPPV, or intubation are ordered for patient during their hospitalization.
One year
Time to ordering of nodal blocking agent
時間枠:One year
Time from heart rate >130 to when a nodal blocking agent (beta blocker, calcium channel blocker, digoxin, or amiodarone) is ordered for patient during their hospitalization.
One year
Time to ordering of insulin
時間枠:One year
Time from glucose >350 or <60 to when insulin is ordered for patient during their hospitalization.
One year
Time to ordering of diuretics or insulin/D50
時間枠:One year
Time from potassium>6 to when diuretics or insulin/D50 is ordered for patient during their hospitalization.
One year
Time to ordering of appropriate fluids
時間枠:One year
Time from sodium>145 or sodium<130 to when appropriate fluids are ordered for patient during their hospitalization.
One year
Time to ordering to discontinue foley catheter
時間枠:One year
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
One year
Time to improvement of hemoglobin
時間枠:One year
Time from hemoglobin <7 to hemoglobin>7
One year
Time to improvement of blood pressure
時間枠:One year
Time from systolic blood pressure<80, diastolic<40 to systolic blood pressure>80, diastolic>40
One year
Time to improvement of oxygen saturation
時間枠:One year
Time from oxygen saturation to <90% to oxygen saturation >90%
One year
Time to improvement of heart rate
時間枠:One year
Time from heart rate >130 to heart rate <130
One year
Time to improvement of glucose
時間枠:One year
Time from glucose >350 or <60 to glucose <350, >60
One year
Time to improvement of potassium
時間枠:One year
Time from potassium >6 to potassium to <6
One year
Time to improvement of sodium
時間枠:One year
Time from sodium >145 or <130 to sodium <145, >130
One year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Aalok V Agarwala, MD, MBA、Massachusetts General Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2017年1月1日

一次修了 (実際)

2017年1月1日

研究の完了 (実際)

2017年1月1日

試験登録日

最初に提出

2016年10月12日

QC基準を満たした最初の提出物

2016年10月13日

最初の投稿 (見積もり)

2016年10月14日

学習記録の更新

投稿された最後の更新 (実際)

2019年10月31日

QC基準を満たした最後の更新が送信されました

2019年10月29日

最終確認日

2019年10月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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