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Completed

NCT Number: NCT04531280

Rural Home Hospital: Proof of Concept

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient clinical inclusion Criteria:

  • >=18 years old
  • Any infectious process (e.g., pneumonia, diverticulitis, cellulitis, complicated urinary tract infection)
  • Heart failure exacerbation
  • Asthma and chronic obstructive pulmonary disease exacerbation
  • Atrial fibrillation with rapid ventricular response
  • Diabetes and its complications
  • Venous thromboembolism: This includes a patient who requires therapeutic anticoagulation and concomitant monitoring (thus requiring inpatient status)
  • Gout exacerbation
  • Chronic kidney disease with volume overload
  • Hypertensive urgency
  • End of life / desires only medical management: Regarding a patient who desires only medical management, this includes a patient who requires acute care for symptom management but declines any surgical intervention. This may include a patient who is about to transition to hospice care, for example, but still has the functional capacity to meet our criteria below. Under these circumstances, we would make sure that various contingencies, including possible transition to hospice care or hospital readmission, are completely understood by patients and caregivers as applicable.

Patient social inclusion criteria:

  • Lives in rural or ultra-rural area (see definitions in Appendix) that can be served by one of our RHH clinicians.
  • Has capacity to consent to study
  • 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 maybe waived for highly competent patients at the patient and clinician's discretion.

Patient caregiver inclusion criteria: (not required for patient participation):

  • Age >= 18 years old
  • Has capacity to consent to study
  • Lives with or nearby to patient

Clinician inclusion criteria:

-Any member of the rural home hospital (RHH) clinical team (MD, RN, paramedic, NP) who will be participating in the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.

Patient Clinical Exclusion Criteria:

  • 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

Treatment and study plan

Home Hospital care

Other

Patients receive hospital-level care in their home.

Primary outcomes

  1. Number of Patients That Completed Their Rural Home Hospitalization

    Time frame: 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.

Secondary outcomes

  1. 3-item Care Transition Measure

    Time frame: Once, within Day of discharge to 7 days later

    This is a hospital level measure of performance that reports the average patient reported quality of preparation for self-care response among adult patients discharged from general acute care hospitals. Data will be collected by a Research Assistant via patient, ( scale of 1 to 12; where 12 indicates highest readiness to transition). The final score is calculated by calculating the sum or responses across the three items ((score Strongly Disagree = 1; Disagree = 2; Agree = 3; Strongly Agree = 4), the number of questions answers are counted, and then the mean response is then calculated (sum divided by count).

  2. Picker Experience Questionnaire

    Time frame: Once, within Day of discharge to 7 days later

    The Picker Patient Experience Questionnaire is a fifteen item questionnaire covering eight domains including information & education and coordination of care. The questionnaire is used to measure patient experience with in-patient care. The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). A problem is defined as any aspect of health care that could be improved upon. Data will be collected by a research assistant via patient. Scale of 1-15, where a higher score indicates better patient experience.

  3. Global Satisfaction: Scale

    Time frame: Once, between Day of discharge to 7 days later

    Measure of patient experience and satisfaction with care using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible. Data will be collected by a Research Assistant via patient

  4. Perceived Acceptability of RHH Care

    Time frame: Day of discharge to 30 days later

    Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.The numbers in the data table reflect the number of patients and clinicians that perceived rural home hospital care to be acceptable.

  5. Perceived Safety, Quality of Care, Caregiver Burden

    Time frame: Day of discharge to 30 days later

    Perceived safety, quality of care, caregiver burden will be assessed qualitatively through one post-discharge semi-structured interview with each participating clinician, patient, and caregiver.

    The numbers in the data table reflect the number of patients and clinicians that perceived that rural home hospital was safe and that the care provided was of high quality.

  6. Number of Rural Home Hospital Patients Escalated to Hospital for Care

    Time frame: Day of admission to day of discharge, estimated 10 days later

    If enrolled patient must be discharged from rural home hospital and taken to an acute-care hospital for care. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

  7. Number of Patients With an Adverse Event

    Time frame: Day of admission to day of discharge, estimated 10 days later

    Adverse events include Fall, Delirium, Potentially preventable Venous Thromboembolism (VTE), New pressure ulcer, Thrombophlebitis at peripheral intravenous line (IV) site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

  8. Number of Patients With Unplanned Mortality During Admission

    Time frame: Day of admission to day of discharge, estimated 10 days later

    Any case of unplanned death among enrolled rural home hospital patient.Data to be collected daily by a research assistant via the Registered Nurse or Paramedic

  9. Lab Orders, Number

    Time frame: Day of admission to day of discharge, estimated 10 days later

    Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records

  10. Length of Stay

    Time frame: Day of admission to day of discharge, estimated 10 days later

    The number of days enrolled patient is admitted to rural home hospital.Data to be collected daily by a research assistant via rural home hospital records.

  11. Unplanned Readmission(s), Number or Patients

    Time frame: 30-days post-discharge

    Unplanned readmission of patient to hospital 30 days post discharge from rural home hospital. Data to be collected by a research assistant via the patient.

  12. ED Visit(s), Number

    Time frame: 30-days post-discharge

    Any Emergency Department (ED) visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Rx Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2020
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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