Rural Home Hospital: Proof of Concept

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04531280

Collaborator

RxFoundation (Other)

Enrollment

Location

Arm

2.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infection Heart Failure Chronic Obstructive Pulmonary Disease Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulants; Increased	Other: Home hospital care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 18, 2021

Actual Primary Completion Date :

May 7, 2021

Actual Study Completion Date :

May 7, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rural home hospitalization accomplished [Day of admission to day of discharge, estimated 10 days later]
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 [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
Picker Experience Questionnaire [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
Global satisfaction: scale [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
Perceived acceptability of RHH care [Day of discharge to 30 days later]
Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.
Perceived safety, quality of care, caregiver burden [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.
Escalation of care to hospital [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
Adverse event [Day of admission to day of discharge, estimated 10 days later]
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 [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
Lab Orders, number [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
Length of stay [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
Unplanned readmission(s) after index, number and yes or no [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.
ED visit(s) after index, number and yes or no [30-days post-discharge]
Any ED visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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