Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept
Phase: NA
Conditions: Infection, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma, Gout Flare, Chronic Kidney Diseases, Hypertensive Urgency, Atrial Fibrillation Rapid, Anticoagulants; Increased
Sponsor: Brigham and Women's Hospital

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DETAILED PROTOCOL 
 
 
Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of 
Concept 
 
 
 
Principal Investigator: Dr. Natalie Como  
 
Sponsor: Rx Foundation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONTENTS 
 
1.0 BACKGROUND AND SIGNIFICANCE  
 
1.1 HISTORICAL BACKGROUND 
 
 
1.1.1 Previous clinical studies 
 
 
1.1.2 Rationale  
 
2.0 SPECIFIC AIMS 
2.1 Primary Aim 
2.2 Secondary Aims  
 
3.0 SUBJECT SELECTION 
3.1 Inclusion  
3.2 Exclusion  
3.3 Source of subjects and recruitment methods  
 
4.0 SUBJECT ENROLLMENT 
4.1 Screening and recruitment 
4.2 Methods of enrollment and Procedures for obtaining consent/ Informed Consent  
4.4 Treatment Assignment  
 
5.0 STUDY PROCEDURES 
5.1 Study visits and measured parameters  
5.2 Drugs to be used 
5.3 Devices to be used  
5.4 Procedures/surgical interventions  
5.5 Data to be collected and when the data will be collected  
5.5.1 Primary endpoint 
5.5.2 Experience endpoints 
5.5.3 Other exploratory endpoints  
5.5.4 Covariates of Interest   
5.6 Standard Operating Procedures for problematic situations  
 
6.0 BIOSTATISTICAL ANALYSIS  
6.1 Quantitative  
6.2 Qualitative  
 
7.0 RISKS AND DISCOMFORTS 
 
8.0 POTENTIAL BENEFITS  
 
9.0 MONITORING AND QUALITY ASSURANCE  
 
10.0 APENDIX  
 
11.0 REFERENCES  

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1.0 BACKGROUND AND SIGNIFICANCE  
 
 
 
1.1 Historical Background 
 
 
 
 
Hospitals are the standard of care for acute illness in the US, but hospital care is 
expensive and often unsafe, particularly for older individuals.1 While admitted, 20% suffer 
delirium,2 over 5% contract hospital-acquired infections,3 and most lose functional status that is 
never regained.4 Timely access to inpatient care is poor: many hospital wards are typically over 
100% capacity, and emergency department waits can be protracted. An acute illness that 
traditionally requires inpatient hospitalization represents a common critical moment in people’s 
lives. Many people worldwide lack access to acute care, some face intense travel burdens to 
obtain care, while others simply go without. Even those who may receive their care in a hospital 
will encounter an environment that may be unsafe and expensive. Maintaining high quality acute 
care facilities in rural areas is a major burden to health care systems. 
 
1.1.1 Previous Clinical studies 
 
 
We have designed, implemented, evaluated, and continue improving on home-based 
acute care (e.g., a “home hospital”) for dense urban environments. The home hospital model of 
care provides in-home acute care to acutely ill patients who would normally be admitted to a 
traditional hospital. Studies of the home hospital model have demonstrated that a sizeable 
proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, 
and improved patient experience.5,6 In late 2016, we launched a randomized controlled trial 
(RCT) of home hospital care, the first RCT to be performed in the US context. With this pilot we 
showed that hospital-level care could be delivered with similar or better quality and safety but at 
lower cost.7 We subsequently completed a larger RCT that corroborated the pilot’s findings, 
additionally demonstrating reduced readmissions for those home hospitalized. Since conclusion 
of this larger RCT, we have enrolled over 500 patients in home hospital care. 
 
1.1.2 Rationale 
 
        About 1 in 5 Americans live in rural areas, totaling nearly 60 million people.8 Living in a 
rural area is associated with higher mortality9 and poor access to health care, with 23% reporting 
an average 34-minute drive to their nearest hospital.10 An acute illness that traditionally requires 
hospitalization represents a common critical moment in nearly every person’s life. While some in 
rural areas face intense travel burdens to obtain acute care, others simply go without. Even those 
who receive care in a hospital may encounter an environment that is unsafe, of poor quality or 
experience, and expensive.11 This may be particularly true of rural hospitals.12,13 In response to 
this unacceptable geographic disparity, over the last year, our team has designed and refined the 
rural home hospital (RHH) model through background research, workflow mapping, 
prototyping, and rapid cycle testing. We conducted a simulation of RHH through a series of 
“mock admissions” with stable but chronically ill patients in rural Utah. We evaluated the 
processes, workflows, and technologies involved in RHH and collected qualitative data from the 
patients, caregivers, and RHH clinical team.  

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           Building on the success of these detailed planning exercises, we propose deploying RHH 
to care for acutely ill patients in rural and ultra-rural settings in Utah as a proof of concept. This 
study will evaluate the feasibility and acceptability of the RHH intervention with 3 patients and 
synthesize key learnings which will be used to refine the RHH model and inform an 
implementation strategy going forward. If the home hospital model can be successfully deployed 
in rural and ultra-rural settings, a paradigm shift in access to acute care will occur, providing this 
care model to rural patients and clinicians. 
 
2.0 SPECIFIC AIMS 
 
2.1 Primary Aim  
Assess the feasibility of home hospital care in rural and ultra-rural settings in the United States 
by deploying a home hospital team to care for acutely ill rural patients at home. 
 
2.2 Secondary Aims 
Asses RHH for its acceptability, experience, quality, and safety.  
 
3.0 SUBJECT SELECTION 
 
3.1 Inclusion  
 
Patient inclusion 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 
o 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 
o 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. 

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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. 
o This criterion may be waived for highly competent patients at the patient and 
clinician’s discretion. 
 
Patient caregiver inclusion criteria: (not required for patient participation):  
o Age >= 18 years old 
o Has capacity to consent to study  
o 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.   
 
 
3.2 Exclusion  
 
Patient exclusion criteria:  
 
Patient exclusion clinical 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:  
o Most recent CURB65 > 3: new confusion, BUN > 19mg/dL, respiratory 
rate>=30/min, systolic blood pressure<90mmHg, Age>=65 (<14% 30-day 
mortality)15 

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o 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)16 
o Absence of clear infiltrate on imaging 
o Cavitary lesion on imaging 
o Pulmonary effusion of unknown etiology 
o O2 saturation < 90% despite 5L O2 
• 
For heart failure: 
o Has a left ventricular assist device 
o GWTG-HF17 (>10% in-hospital mortality) or ADHERE18 (high risk or 
intermediate risk 1)* 
o Severe pulmonary hypertension 
• 
For complicated urinary tract infection: 
o Absence of pyuria 
o Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if 
sepsis, >10% mortality)19 
• 
For other infection 
o Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if 
sepsis, >10% mortality)19 
• 
For COPD 
o BAP-65 score > 3 (BUN>25, altered mental status, HR>109, age>65) (<13% 
chance in-hospital mortality): exercise caution 
• 
For asthma 
o Peak expiratory flow < 50% of normal: exercise caution 
• 
For diabetes and its complications 
o Requires IV insulin 
• 
For hypertensive urgency 
o Systolic blood pressure > 190 mmHg 
o Evidence of end-organ damage; for example, acute kidney injury, focal 
neurologic deficits, myocardial infarction 
• 
For atrial fibrillation with rapid ventricular response 
o Likely to require cardioversion 
o New atrial fibrillation with rapid ventricular response 
o Unstable blood pressure, respiratory rate, or oxygenation 
o Despite IV beta and/or calcium channel blockade in the emergency department, 
HR remains > 125 and SBP remains different than baseline 
o 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 
o Peritoneal catheter malfunction 
o 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 

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Patient social exclusion criteria:  
 
o Non-english speaking 
o Undomiciled 
o No working heat (October-April), no working air conditioning if forecast > 80°F 
(June-September), or no running water 
o On methadone requiring daily pickup of medication 
o In police custody 
o Resides in facility that provides on-site medical care (e.g., skilled nursing facility) 
o Domestic violence screen positive8 
 
3.3 Source of subjects and recruitment methods  
 
All subjects will be associated with the University of Utah Health system. The University of 
Utah Health has agreed to serve as research collaborator.  
 
A patient may be considered for RHH care if they are acutely ill at home, present acutely ill to a 
clinic or emergency department, or if they are admitted and require additional days of acute care 
(“early transfer”): 
• If at home: this patient phenotype is well-known to her/his physician and has an acute 
illness of highly likely etiology (e.g., heart failure or chronic obstructive pulmonary 
disease exacerbation). The patient’s care team (perhaps primary care or a specialist) will 
receive a call from the patient describing acute symptoms. The care team will call the 
RHH nurse practitioner (NP) to describe the case. If appropriate, the RHH NP will call 
the patient to determine eligibility and interest. If eligible, the RHH MD will make the 
decision to admit and the MD or NP will consent the patient.  
• If presenting acutely ill to a clinic: after appropriate assessment by the clinic care team, 
and if the team believes the patient requires admission, the clinic care team will call the 
RHH NP to describe the case. If appropriate, the RHH NP will call the patient to 
determine eligibility and interest. If eligible, the RHH MD  or NP will consent the 
patient. The patient will be transported home in an appropriate transport (personal car, 
chair car, or ambulance). The RHH nurse/paramedic will meet the patient in their home. 
• If presenting acutely ill to an emergency department: after appropriate assessment by the 
emergency department team, and if the team believes the patient requires admission, the 
emergency department care team will call the RHH NP to describe the case. If 
appropriate, the RHH NP will call the patient to determine eligibility and interest. If 
eligible, the RHH MD or NP will consent the patient. The patient will be transported 
home in an appropriate transport (personal car, chair car, or ambulance). The RHH 
nurse/paramedic will meet the patient in their home. 
• If admitted and requiring additional days of acute care (“early transfer”): an ideal patient 
for this setting is a patient with a heart failure exacerbation requiring additional days of 
IV diuresis and close monitoring including daily electrolyte and telemetry monitoring. 
Patients who require additional days of acute care but could be cared for with RHH will 

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be approached for enrollment after discussion with the RHH NP, RHH MD, and hospital 
care team, ensuring it is an appropriate time to approach for enrollment. If the patient and 
all stakeholders are in agreement with RHH, the patient will be enrolled and consented to 
RHH by the RHH MD or NP. The patient will be transported home in an appropriate 
transport (personal car, chair car, or ambulance). The RHH nurse/paramedic will meet the 
patient in their home. 
 
 
4.0 SUBJECT ENROLLMENT 
 
4.1 Screening and recruitment 
 
Patients:  
• Acutely ill patient is screened and recruited as above. 
• If participant agrees, the RHH MD will further describe the program, answer initial 
questions, and further assess whether the participant meets inclusion/exclusion non-
clinical (e.g., social) and clinical criteria (please see the subject eligibility checklist)  
 
Clinicians  
• Members of the rural home hospital clinical team (MD, RN, paramedic, NP) that have 
expressed interest in participating in research activities and meet inclusion criteria will be 
approached by a member of the study team.  
 
4.2 Methods of enrollment and procedures for obtaining consent/ informed consent 
 
Clinicians:  
 
• If the clinician meets inclusion criteria, then the study team will invite them to 
participate. The research assistant will explain the purpose of the study, answer initial 
questions, and seek written informed consent from clinician participants.  
 
Patients:  
• If the participant has interest in the program and meets inclusion/exclusion criteria, the 
MD (either over the phone or via a live video visit) or NP will obtain written informed 
consent of the participant to enroll in the RHH study.  
• The MD will make the final decision to admit the patient to home hospital. 
 
 

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Figure 1.  
 
 
4.4 Treatment Assignment  
 
All eligible and agreeable patients will be enrolled in RHH.  
 
5.0 STUDY PROCEDURES 
 
5.1 Study visits and measured parameters  
 
Each day, the RHH clinical team will make in-person and/or virtual visits to the patient’s home. 
These are personnel who have been trained in home health and carry out home health as per the 
usual care they deliver. The RHH module offers most of the same medical components that are 
standard of care in an acute care hospital (Table below). The typical staff (MD, RN or 
paramedic), diagnostics (blood tests, vital signs, telemetry), intravenous therapy, and 
oxygen/nebulizer therapy will all be available for home hospital.  
 
RHH improves upon the components of a typical ward’s standard of care in several ways: 
• Point of care blood diagnostics (results at the bedside in <5 minutes); 
• Minimally invasive continuous vital signs, telemetry, and activity tracking 
• 24/7 clinician video visits; 
• Ambulatory/portable infusion pumps that can be worn on the hip; 

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Table 1. 
 
As denoted in the table above, the physician will make at least one daily virtual visit to the 
patient’s home, facilitated by the nurse/paramedic. At the discretion of the physician and 
nurse/paramedic, the physician can make additional virtual visits should the patient’s clinical 
condition require it. Similarly, the nurse/paramedic will make at least two daily visits to the 
patient’s home. At the discretion of the physician and nurse/paramedic, the nurse/paramedic can 
make additional visits should the patient’s clinical condition require it. This will be an ongoing 
twice daily discussion among clinicians, patient, and caregivers, as applicable. A patient or 
clinician can initiate a video visit at any time. As denoted in the table above, the RHH team uses 
a suite of communication software to communicate with the patient and among team members.  
 
For patients with chronic/stable dementia, they will receive mental status assessments (eg, 
Confusion Assessment Method) by the home hospital RN/paramedic at each visit (at least 2 
daily). As is standard of care, we will take measures to avoid delirium: open blinds to allow light 
in during the day, minimize environmental noise, encourage typical routines to optimize eating 
and sleeping, and reassess medication list for culprit medications.  
 
Clinical parameters measured will be at the discretion of the physician and nurse/paramedic, who 
treat the participant following evidence-based practice guidelines, just as in the usual care 
setting. Monitoring and data collection will be performed by RHH clinicians. The clinical home 
hospital team manually checks vital signs at least daily. If deemed necessary based on a patient’s 
acuity, the home hospital team can visit additional times. At all times, the patient and care team 
have 24/7 access to the RHH attending physician. 
 
On top of this “on-the-ground” team, the home hospital attending is notified with an alarm 
should there be delayed data transfer. Such an alarm would cause the attending to contact the 
patient as deemed clinically appropriate.  

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Please see below for all collected data points. 
 
Documentation by RN/paramedic and MD will occur via digital intake notes, daily progress 
notes, and discharge notes that will be compiled (on a secure shared drive) and uploaded as a 
scanned document to the patient’s chart upon discharge.  
 
START:
Patient Needs Acute 
Care
Hospital
Clinic
MD
Home
ED
Screening
Rural HH 
Team
Care Plan
Home
Patient
Deployment
Patient Welcome & 
Education
Medical Evaluation
Text & Video
24/7 Patient 
Monitoring & 
Communication
Daily Rounding
Tech Practice
END:
Discharge
Biometric 
Monitoring
PRN
Patient
Remote MD 1x 
Daily + PRN
Rural HH Triage
Nurse 2x 
Daily + 
PRN
Tech
Remote MD
HH Nurse
Education
 
Figure 2 RHH flow. Note a patient may enter this flow from their home, a clinic, the emergency 
department, or the hospital floor. The patient is triaged by the RHH nurse with as needed 
assistance of the RHH MD. The RHH nurse/paramedic deploys in the patient’s home, facilitates 
a medical evaluation by a remote MD, welcomes and educates the patient, and sets up 
monitoring and communication technology. The nurse rounds at least once to twice daily in 
person, facilitating an interaction with the RHH MD. Finally, the patient is discharged using the 
same criteria for discharge as would be used in a traditional hospital (ability to perform activities 
of daily living given supports in the home). 
 
5.2 Drugs to be used 
 
Only medications used in the usual care of hospitalized patients will be used. For example, a 
patient with pneumonia might receive guideline-based antibiotics with ceftriaxone and 
azithromycin. 
 

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5.3 Devices to be used  
 
• Home hospital employs standard devices during the usual care of hospitalized patients. 
For example, a nebulizer machine. 
• Home hospital additionally employs 
o Vital signs monitoring patch: Vital Connect VitalPatch (FDA cleared 
application/use) or BioIntellisense BioSticker (FDA cleared application/use) 
o Ambulatory infusion pump: Smiths Medical CADD Solis VIP (FDA cleared 
application/use) 
o Point of care diagnostic meter: Abbott iSTAT (FDA cleared application/use) or 
Siemens EPOC (FDA cleared application/use) 
 
5.4 Procedures/surgical interventions  
 
• Home hospital employs the same standard procedures used during the usual care of 
hospitalized patients. For example, peripheral venipuncture. Need for surgery is an 
exclusion criterion. 
 
5.5 Data to be collected and when the data will be collected  
 
5.5.1 Primary endpoint 
Outcome measure 
Data sources 
Day(s) Obtained 
RHH admission, daily care, and 
discharge processes 
accomplished 
Process checklist (attachment) 
and semi-structured interviews 
with clinicians  
Daily  
 
5.5.2 Secondary endpoints 
Outcome measure 
Data sources 
Day(s) Obtained 
3-item Care Transition 
Measure 
RA via patient 
Within 1 week of 
discharge 
Picker Experience 
Questionnaire 
RA via patient 
Within 1 week of 
discharge 
Global satisfaction 
RA via patient 
Within 1 week of 
discharge 
Perceived acceptability of 
RHH care 
Post-discharge semi-structured 
interviews with clinicians, patients, and 
caregivers 
Within 1 month 
of discharge 
Perceived safety, quality of 
care, caregiver burden 
Post-discharge semi-structured 
interviews with clinicians, patients, 
caregivers 
Within 1 month 
of discharge 
Escalation of care to hospital 
RA via RN/EMTP 
Daily 
Adverse event* 
RA via RN/EMTP 
Daily 
Unplanned mortality during 
admission 
RA via RN/EMTP 
Daily 

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Lab Orders, # 
RA via RHH records 
Daily 
Length of stay 
RA via RHH records 
Discharge 
Unplanned readmission(s) 
after index, # and y/n 
RA via patient 
30-days post-
discharge 
ED visit(s) after index, # and 
y/n 
RA via patient 
30-days post-
discharge 
*: see appendix 
 
5.5.3 Covariates of Interest 
Outcome measure 
Data sources 
Day(s) Obtained 
Age 
RA via patient 
Admission 
Gender 
RA via patient 
Admission 
Race/ethnicity 
RA via patient 
Admission 
Primary language 
RA via patient 
Admission 
Health insurance status, 
public/private/none 
RA via patient 
Admission 
Comorbidities, type and # 
RA via EHR 
and H&P 
Admission 
Partner status 
RA via patient 
Admission 
Education 
RA via patient 
Admission 
Zip code 
RA via patient 
Admission 
Employment 
RA via patient 
Admission 
Smoking status 
RA via H&P 
Admission 
Medications used as outpatient, # 
RA via patient 
Admission 
DNR/I code status 
RA via H&P 
Admission 
Home health aide prior to admission 
RA via patient 
Admission 
Elective and urgent admissions in the 
previous year, # 
RA via patient 
Admission 
ED visits in the previous 6 months, # 
RA via patient 
Admission 
PRISMA-7 
RA via patient 
Admission 
Eight-item Interview to Differentiate 
Aging and Dementia 
RA via patient 
or proxy 
Admission 
Would you be surprised if this patient 
died in the next year? 
RA via MD 
Admission 
BRIEF health literacy screening tool 
RA via patient 
Admission 
Lives alone 
RA via patient 
Admission 
 
5.6 Standard Operating Procedures for problematic situations  
 
Any subjects presenting with problematic situations will be immediately transferred to the most 
appropriate hospital and formally withdrawn from the study 
 
Clinically Emergent Patient Condition 
 

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Should a matter be emergent, then 9-1-1 will be called and the patient will be brought to the 
hospital immediately. An example of an emergent patient condition is severe new-onset 
shortness of breath. 
 
Clinically Urgent Patient Condition 
Should a matter be urgent, the patient and/or nurse/paramedic and/or physician may choose to 
communicate via phone or video (either of the 3 persons can initiate either medium). If this is 
unsuccessful, the nurse/paramedic will attempt to visit the patient in their home. If there is no 
way to rectify the situation, then the patient will be transported to the hospital. An example of an 
urgent situation is new-onset non-severe pain. 
 
Unsafe Home Situation 
Should an unsafe home situation be discovered during a home hospital admission, the home 
hospital team will assess if said situation poses a harm or threat to either the participant or the 
home hospital personnel. If it does, and after an attempt to rectify said situation, the situation 
persists, then the home hospital team will end the study and transport the patient to the hospital. 
An example of an unsafe home situations includes lack of basic sanitation. 
 
Intoxication 
Should intoxication occur in the home of a participant, the home hospital team will assess if said 
intoxication poses a harm or threat to either the participant or the home hospital personnel. If it 
does, and after an attempt to rectify said intoxication, the situation persists, then the home 
hospital team will end the study and transfer the patient to the hospital. 
 
Neglect or child abuse 
Should neglect or child abuse be observed, the home hospital team will act as mandatory 
reporters. The home hospital team, in coordination with the hotline team, will assess if said 
neglect or child abuse poses an immediate harm or threat to either the participant, children in the 
home, or the home hospital personnel. If it does, then the home hospital team will end the study 
and transport the patient to the hospital. 
 
Refusal of care 
Should an enrolled subject refuse standard care at their home despite a clear discussion with the 
home hospital team, then the subject will be transferred back to the treating hospital and formally 
withdrawn from the study. 
 
6.0 BIOSTATISTICAL ANALYSIS  
 
6.1 Quantitative 
Given our small planned enrollment of 3 patients, we will present our quantitative findings either 
as individual data points or with medians and interquartile ranges. We plan no formal statistical 
testing. 
 
6.2 Qualitative 
We will conduct qualitative interviews with the RHH clinical care team, patient, and caregivers 
daily during admission and post-discharge. Semi-structured interviews will be recorded, 

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transcribed, and then analyzed using NVivo qualitative analysis software. We will audio record 
interviews to a local microphone system and send them for transcription to a HIPAA-compliant 
transcription service. Qualitative data will be analyzed using descriptive content analysis, two 
researchers will code the data independently. Following initial descriptive coding, themes and 
recurrent patterns may be identified with any differences resolved by consensus.  
 
7.0 RISKS AND DISCOMFORTS 
 
Uncommon: Complications of surgical and non-surgical procedures 
Standard hospital procedures carry small risks and discomforts. For example, venipuncture can 
be painful and can lead to thrombophlebitis, but this is uncommon and readily rectifiable. 
Uncommon: Device complications/malfunctions 
IV pumps, vital signs monitoring patches, and the other devices used during home hospital 
uncommonly have malfunctions. 
Uncommon: Radiation risks 
Patients can receive radiography while admitted to home hospital, much the same as when they 
are admitted in the hospital. We do not anticipate that home hospital will in any way change the 
prevailing risk of radiation. 
Common (but unchanged from usual care): Drug side effects and toxicities 
Drug side effects and toxicities do occur during inpatient medicine, despite following best 
practices and evidence based medicine. We do not anticipate that home hospital will in any way 
change the prevailing rate of drug side effects and toxicities compared to usual care. For 
example, acute kidney injury can occur in patients receiving antibiotics, even when correct 
dosing occurs. Home hospital is equipped to monitor and respond to the common drug side 
effects and toxicities much the same as the standard of care (monitoring, diagnostics, fluids, etc). 
Common (but improved from usual care): Psychosocial risks 
Admission to the hospital can be a psychosocially difficult event, particularly for a senior. We 
believe home hospital will alleviate these typical risks.  
 
8.0 POTENTIAL BENEFITS  
 
• Remain in their home despite acute illness 
o Eat their own culturally concordant food 
o Sleep in familiar surroundings 
o Maximize time and interactions with their family and friends 
• Improved health outcomes (we anticipate these from previous literature) 
o Reduced length of stay 
o Reduced complications while admitted 
▪ Less delirium 
▪ Fewer falls 
▪ Fewer health care associated infections 

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▪ Decreases reduction in functional status 
o Improved patient experience 
• Clinical improvements to the standard of care  
o Point of care blood diagnostics (results at the bedside in <5 minutes); 
o Minimally invasive continuous vital signs, telemetry, and activity tracking, 
including clinical deterioration algorithms, steps taken, and sleep quality; 
o On-demand 24/7 clinician virtual video visits; 
o Ambulatory/portable infusion pumps that can be worn on the hip; 
• Improved transitions of care 
o Ability to coach patients on their post-discharge care plan in the appropriate 
environment, with caregivers available, and with adequate time for teaching given 
provider to patient ratio 
Potential benefits to society 
 
• New evidence-based care paradigm for acute care hospitalization. 
• Lower total medical expenditure. Allows for redirection of resources to areas in need. 
• Might eventually lead to reduction in total hospitals in the U.S. 
 
9.0 MONITORING AND QUALITY ASSURANCE  
Independent monitoring of source data 
The study’s research assistant will collect all data denoted above. The PI will monitor the source 
data throughout the project. 
Safety monitoring 
If any of the following concerning safety events occur, a blinded monitoring committee will 
review the event to determine attribution to the intervention: fall, medication error, DVT/PE, 
mortality during admission, transfer back to hospital (committee cannot be blinded for this 
endpoint). If any of these events are felt to be due to the RHH intervention, they will be reported 
to the IRB with recommendations for appropriate actions to be taken. Decisions to modify the 
protocol or suspend the study will be made jointly by the study investigators, monitoring 
committee, and the IRB.   
Outcomes monitoring 
The MD and RN/paramedics will daily review quality and safety data as part of a rapid logistics 
improvement process. 
 
Weekly, the MD and RN/paramedic will huddle to review quality and safety data as part of a 
rapid logistics improvement process. 
 
Adverse event reporting guidelines 
All adverse events denoted above under safety monitoring will be reported to the monitoring 
committee. 

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10.0 APENDIX  
 
Rural definition and Ultra- rural definition:  
 
Rural:  
• Centers for Medicare & Medicaid Services (CMS) ambulance fee schedule: EMS 
super rural  
• Rural-Urban Commuting Area Codes (RUCA) 4-10  
• Frontier and Remote Area Codes (FAR) less than or equal to 4 
 
Ultra-rural: 
 
• Centers for Medicare & Medicaid Services (CMS) ambulance fee schedule: EMS super 
rural  
• Rural-Urban Commuting Area Codes (RUCA) 10 
• Frontier and Remote Area Codes (FAR) 4 
 
 
Adverse events 
 
• Fall 
• Delirium 
• Potentially preventable VTE 
• New pressure ulcer 
• Thrombophlebitis at peripheral IV site 
 
 
 
 
 
 
 
11.0 REFERENCES  
 
 
1.  
Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly 
(MACE) service. JAMA Intern Med. 2013;173(11):990-996. 
doi:10.1001/jamainternmed.2013.478. 
2.  
Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and 
treatment. Nat Rev Neurol. 2009;5(4):210-220. doi:10.1038/nrneurol.2009.24. 
3.  
2014 National and State Healthcare-Associated Infections Progress Report.; 2016. 
http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016. 
4.  
Counsell SR, Holder CM, Liebenauer LL, et al. Effects of a Multicomponent Intervention 

Version 1.0_04.20.2020 
 
 
18
on Functional Outcomes and Process of Care in Hospitalized Older Patients: A 
Randomized Controlled Trial of Acute Care for Elders (ACE) in a Community Hospital. J 
Am Geriatr Soc. 2000;48(12):1572-1581. doi:10.1111/j.1532-5415.2000.tb03866.x. 
5.  
Leff B, Burton L, Mader SL, et al. Hospital at home: feasibility and outcomes of a 
program to provide hospital-level care at home for acutely ill older patients. Ann Intern 
Med. 2005;143(11):798-808. http://www.ncbi.nlm.nih.gov/pubmed/16330791. Accessed 
February 15, 2016. 
6.  
Cryer L, Shannon SB, Van Amsterdam M, Leff B. Costs for “hospital at home” patients 
were 19 percent lower, with equal or better outcomes compared to similar inpatients. 
Health Aff (Millwood). 2012;31(6):1237-1243. doi:10.1377/hlthaff.2011.1132. 
7.  
Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, and Schnipper JL. 
Hospital-Level Care at Home for Acutely Ill Adults: A Pilot Randomized Controlled 
Trial. J Gen Intern Med. 2018; 33(5):729-736. doi: 10.1007/s11606-018-4307-z 
8  
Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-
america.html. Published 2017. Accessed May 31, 2019.  
9  
Garcia MC, Rossen LM, Bastian B, et al. Potentially Excess Deaths from the Five Leading 
Causes of Death in Metropolitan and Nonmetropolitan Counties — United States, 2010–
2017. MMWR Surveill Summ. 2019;68(10):1-11. doi:10.15585/mmwr.ss6810a1  
10  
Parker K, Horowitz J, Brown A, Fry R, Cohn D, Igielnik R. What Unites and Divides 
Urban, Suburban and Rural Communities.; 2018. 
https://www.pewsocialtrends.org/wpcontent/uploads/sites/3/2018/05/Pew-Research-
Center-Community-Type-Full-Report-FINAL.pdf. Accessed May 31, 2019 
11. 
Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993;118(3):219-
223. http://www.ncbi.nlm.nih.gov/pubmed/8417639. Accessed May 31, 2019.  
12.  
Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical 
access and non-critical access hospitals, 2002-2010. JAMA. 2013;309(13):1379-1387. 
doi:10.1001/jama.2013.2366  
13  
Joynt KE, Harris Y, Orav EJ, Jha AK. Quality of Care and Patient Outcomes in Critical 
Access Rural Hospitals. JAMA. 2011;306(1):45-52. doi:10.1001/jama.2011.902