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Using a Remote Patient Monitoring Alert System to Improve Care

2019년 10월 29일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

65년 이상 (고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mortality
기간: One year
Whether a patient experiences death during their hospitalization.
One year
Transfer to the ICU
기간: One year
Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.
One year
Cardiac arrest
기간: One year
Whether the patient experiences a cardiac arrest during their hospitalization.
One year
Rapid response team called
기간: One year
Whether the a rapid response team is called to assess the patient during their hospitalization.
One year

2차 결과 측정

결과 측정
측정값 설명
기간
Time to ordering of blood
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: One year
Time from foley catheter insertion to foley catheter discontinuation during their hospitalization.
One year
Time to improvement of hemoglobin
기간: One year
Time from hemoglobin <7 to hemoglobin>7
One year
Time to improvement of blood pressure
기간: 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
기간: One year
Time from oxygen saturation to <90% to oxygen saturation >90%
One year
Time to improvement of heart rate
기간: One year
Time from heart rate >130 to heart rate <130
One year
Time to improvement of glucose
기간: One year
Time from glucose >350 or <60 to glucose <350, >60
One year
Time to improvement of potassium
기간: One year
Time from potassium >6 to potassium to <6
One year
Time to improvement of sodium
기간: One year
Time from sodium >145 or <130 to sodium <145, >130
One year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Aalok V Agarwala, MD, MBA, Massachusetts General Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2017년 1월 1일

기본 완료 (실제)

2017년 1월 1일

연구 완료 (실제)

2017년 1월 1일

연구 등록 날짜

최초 제출

2016년 10월 12일

QC 기준을 충족하는 최초 제출

2016년 10월 13일

처음 게시됨 (추정)

2016년 10월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 10월 29일

마지막으로 확인됨

2019년 10월 1일

추가 정보

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아니요

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