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临床试验/NCT04080570
NCT04080570已完成不适用

Remote Physician Care for Home Hospital Patients: A Randomized Controlled Trial

Brigham and Women's Hospital4 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2019年8月3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
172
试验地点
4
主要终点
Adverse events, #

研究概览

简要总结

This study examines the implications of providing remote physician care to home hospitalized patients compared to usual home hospital care with in-person/in-home physician visits.

详细描述

Home hospital care is hospital-level care at home for acutely ill patients. In multiple publications, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models require a licensed independent practitioner to see their patients physically in their home.

To further improve the efficiency and scalability of home hospital care, the investigators propose to test remote care, where the physician would provide care via a video interaction, instead of in-home/in-person care. The investigators propose a non-inferiority evaluation of this intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • Resides within either a 5-mile or 20 minute driving radius of emergency department
  • Has capacity to consent to study OR can assent to study and has proxy who can consent
  • >= 18 years-old
  • Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion.
  • Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.

排除标准

  • Undomiciled
  • No working heat (October-April), no working air conditioning if forecast > 80°F (June-September), or no running water
  • On methadone requiring daily pickup of medication
  • In police custody
  • Resides in facility that provides on-site medical care (e.g., skilled nursing facility)
  • Domestic violence screen positive
  • Acute delirium, as determined by the Confusion Assessment Method2
  • Cannot establish peripheral access in emergency department (or access requires ultrasound guidance, unless point-of-care ultrasound is available)
  • Secondary condition: end-stage renal disease on hemodialysis, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
  • Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
  • Cannot independently ambulate to bedside commode, unless home-based aides are available
  • As deemed by on-call MD, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
  • High risk for clinical deterioration
  • Home hospital census is full

结局指标

主要结局

Adverse events, #

时间窗: From date of admission to date of discharge (except for 30-day mortality), an expected average of 4 days

The per patient count of adverse events, including fall, delirium, potentially preventable venous thromboembolism, new pressure ulcer, thrombophlebitis at peripheral IV site, catheter-associated urinary tract infection, new Clostridium difficile, new methicillin-resistant Staphylococcus aureus, new arrhythmia, hypokalemia, acute kidney injury, transfer back to hospital, mortality (unplanned) during admission, mortality (unplanned) 30-day post-discharge.

次要结局

  • Global experience, score(Day of discharge, an expected average of 4 days)
  • Unplanned readmission after index admission, y/n(Day of discharge to 30 days later)
  • Picker experience questionnaire, score(Day of discharge, an expected average of 4 days)

研究者

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

David Levine

Instructor in Medicine

Brigham and Women's Hospital

研究点 (4)

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