Rural Home Hospital: Proof of Concept

December 20, 2024 updated by: David Levine, Brigham and Women's Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home hospital care
Patients receive hospital-level care in their home, as a substitute to traditional hospital care
Other: Home hospital care
Patients receive hospital-level care in their home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of admission to day of discharge, estimated 10 days later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Once, within Day of discharge to 7 days later
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.
Once, within Day of discharge to 7 days later
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
Once, between Day of discharge to 7 days later
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.
Day of discharge to 30 days later
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.
Day of discharge to 30 days later
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
Day of admission to day of discharge, estimated 10 days later
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
Day of admission to day of discharge, estimated 10 days later
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
Day of admission to day of discharge, estimated 10 days later
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
Day of admission to day of discharge, estimated 10 days later
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.
Day of admission to day of discharge, estimated 10 days later
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.
30-days post-discharge
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
30-days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Rx Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Actual)

May 7, 2021

Study Completion (Actual)

May 7, 2021

Study Registration Dates

First Submitted

August 2, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P000708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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