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临床试验/NCT04531280
NCT04531280已完成不适用

Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年2月18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
7
试验地点
2
主要终点
Number of Patients That Completed Their Rural Home Hospitalization

研究概览

简要总结

This study examines the implications of providing hospital-level care in rural homes.

详细描述

Home hospital care is hospital-level care at home for acutely ill patients. In multiple publications mostly in urban environments, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models deliver care in urban environments, not in rural environments.

To further improve the model, the investigators propose to determine the feasibility of home hospital care in a rural home setting through a proof-of-concept approach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • 未提供

排除标准

  • Acute delirium, as determined by the Confusion Assessment Method
  • Cannot establish peripheral access (or access requires ultrasound guidance, unless ultrasound guidance is available)
  • Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
  • Primary diagnosis requires controlled substances
  • Cannot independently ambulate to bedside commode
  • As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
  • For pneumonia: Most recent CURB65 > 3: new confusion, BUN > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65 (<14% 30-day mortality); Most recent SMRTCO > 2: systolic blood pressure < 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90% (<10% chance of intensive respiratory or vasopressor support); Absence of clear infiltrate on imaging; Cavitary lesion on imaging; Pulmonary effusion of unknown etiology; O2 saturation < 90% despite 5L O2
  • For heart failure: Has a left ventricular assist device; GWTG-HF17 (>10% in-hospital mortality) or ADHERE18 (high risk or intermediate risk 1)*; Severe pulmonary hypertension
  • For complicated urinary tract infection: Absence of pyuria; Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)
  • For other infection: Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality)
  • For COPD: BAP-65 score > 3 (BUN>25, altered mental status, HR>109, age>65) (<13% chance in-hospital mortality): exercise caution
  • For asthma: Peak expiratory flow < 50% of normal: exercise caution
  • For diabetes and its complications: Requires IV insulin
  • For hypertensive urgency: Systolic blood pressure > 190 mmHg; Evidence of end-organ damage; for example, acute kidney injury, focal neurologic deficits, myocardial infarction
  • For atrial fibrillation with rapid ventricular response: Likely to require cardioversion; New atrial fibrillation with rapid ventricular response; Unstable blood pressure, respiratory rate, or oxygenation; Despite IV beta and/or calcium channel blockade in the emergency department, HR remains > 125 and SBP remains different than baseline; Less than 1 hour of time has elapsed with HR < 125 and SBP similar or higher than baseline
  • For patients with end-stage renal disease on peritoneal dialysis: Peritoneal catheter malfunction; Requires temporary hemodialysis
  • Home hospital census is full (maximum 3 patients at any time)
  • GWTG-HF: AHA Get with the Guidelines: SBP, BUN, Na, Age, HR, Black race, COPD ADHERE: Acute decompensated heart failure national registry: BUN, creatinine, SBP
  • Patient social exclusion criteria:
  • Non-english speaking
  • 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

结局指标

主要结局

Number of Patients That Completed Their Rural Home Hospitalization

时间窗: Day of admission to day of discharge, estimated 10 days later

Rural home hospital is when eligible rural patients receive hospital level care at home. This measure includes patients that were hospitalized in rural home hospital for treatment for their acute condition and were discharged from rural home hospital after their treatment was complete. The number in the data table reflects the number of patients that completed their home hospitalization.

次要结局

  • 3-item Care Transition Measure(Once, within Day of discharge to 7 days later)
  • Picker Experience Questionnaire(Once, within Day of discharge to 7 days later)
  • Length of Stay(Day of admission to day of discharge, estimated 10 days later)
  • Global Satisfaction: Scale(Once, between Day of discharge to 7 days later)
  • Perceived Acceptability of RHH Care(Day of discharge to 30 days later)
  • Perceived Safety, Quality of Care, Caregiver Burden(Day of discharge to 30 days later)
  • Number of Rural Home Hospital Patients Escalated to Hospital for Care(Day of admission to day of discharge, estimated 10 days later)
  • Number of Patients With an Adverse Event(Day of admission to day of discharge, estimated 10 days later)
  • Number of Patients With Unplanned Mortality During Admission(Day of admission to day of discharge, estimated 10 days later)
  • Unplanned Readmission(s), Number or Patients(30-days post-discharge)
  • Lab Orders, Number(Day of admission to day of discharge, estimated 10 days later)
  • ED Visit(s), Number(30-days post-discharge)

研究者

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

David Levine

Dr. David Levine MD, MPH, MA

Brigham and Women's Hospital

研究点 (2)

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