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Rural Home Hospital: Proof of Concept

Primary Purpose

Infection, Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home hospital care
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring home hospital, hospital at home, hospital in the home

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home hospital care

Arm Description

Patients receive hospital-level care in their home, as a substitute to traditional hospital care.

Outcomes

Primary Outcome Measures

Rural home hospitalization accomplished
Completion of rural home hospitalization using a checklist to assess process completion on a scale of excellent, very good, good, fair, poor or does not apply.

Secondary Outcome Measures

3-item Care Transition Measure
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
Picker Experience Questionnaire
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
Global satisfaction: scale
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
Perceived acceptability of RHH care
Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.
Perceived safety, quality of care, caregiver burden
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.
Escalation of care to hospital
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
Adverse event
Adverse events include Fall, Delirium, Potentially preventable VTE, New pressure ulcer, Thrombophlebitis at peripheral IV site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic
Unplanned mortality during admission
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
Lab Orders, number
Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records
Length of stay
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
Unplanned readmission(s) after index, number and yes or no
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.
ED visit(s) after index, number and yes or no
Any ED visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient

Full Information

First Posted
August 2, 2020
Last Updated
July 6, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
RxFoundation
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1. Study Identification

Unique Protocol Identification Number
NCT04531280
Brief Title
Rural Home Hospital: Proof of Concept
Official Title
Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2021 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
RxFoundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Gout Flare, Chronic Kidney Diseases, Hypertensive Urgency, Atrial Fibrillation Rapid, Anticoagulants; Increased
Keywords
home hospital, hospital at home, hospital in the home

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home hospital care
Arm Type
Experimental
Arm Description
Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
Intervention Type
Other
Intervention Name(s)
Home hospital care
Intervention Description
Patients receive hospital-level care in their home.
Primary Outcome Measure Information:
Title
Rural home hospitalization accomplished
Description
Completion of rural home hospitalization using a checklist to assess process completion on a scale of excellent, very good, good, fair, poor or does not apply.
Time Frame
Day of admission to day of discharge, estimated 10 days later
Secondary Outcome Measure Information:
Title
3-item Care Transition Measure
Description
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
Time Frame
Day of discharge to 7 days later
Title
Picker Experience Questionnaire
Description
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
Time Frame
Day of discharge to 7 days later
Title
Global satisfaction: scale
Description
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
Time Frame
Day of discharge to 7 days later
Title
Perceived acceptability of RHH care
Description
Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.
Time Frame
Day of discharge to 30 days later
Title
Perceived safety, quality of care, caregiver burden
Description
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.
Time Frame
Day of discharge to 30 days later
Title
Escalation of care to hospital
Description
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
Time Frame
Day of admission to day of discharge, estimated 10 days later
Title
Adverse event
Description
Adverse events include Fall, Delirium, Potentially preventable VTE, New pressure ulcer, Thrombophlebitis at peripheral IV site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic
Time Frame
Day of admission to day of discharge, estimated 10 days later
Title
Unplanned mortality during admission
Description
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
Time Frame
Day of admission to day of discharge, estimated 10 days later
Title
Lab Orders, number
Description
Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records
Time Frame
Day of admission to day of discharge, estimated 10 days later
Title
Length of stay
Description
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
Time Frame
Day of admission to day of discharge, estimated 10 days later
Title
Unplanned readmission(s) after index, number and yes or no
Description
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.
Time Frame
30-days post-discharge
Title
ED visit(s) after index, number and yes or no
Description
Any ED visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient
Time Frame
30-days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Rural Home Hospital: Proof of Concept

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