Hospital-Level Care at Home for Acutely Ill Adults

Asthma Clinical Trial

Official title:

Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203759
• Other study ID #: P001337
• Status: Completed
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: August 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited 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.

Description:

Hospitals are the standard of care for acute illness in the United States, but hospital care is expensive and often unsafe, especially for older individuals. While admitted, 20% suffer delirium, over 5% contract hospital-acquired infections, and most lose functional status that is never regained. Timely access to inpatient care is poor: many hospital wards are typically over 100% capacity, and emergency department waits can be protracted. Moreover, hospital care is increasingly costly: many internal medicine admissions have a negative margin (i.e., expenditures exceed hospital revenues) and incur patient debt.

The investigators propose a home hospital model of care that substitutes for treatment in an acute care 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, 20% reduced cost, and 20% improved patient experience. While this is the standard of care in several developed countries, only 2 non-randomized demonstration projects have been conducted in the United States, each with highly local needs. Taken together, home hospital evidence is promising but falls short due to non-robust experimental design, failure to implement modern medical technology, and poor enlistment of community support.

The home hospital module offers most of the same medical components that are standard of care in an acute care hospital. The typical staff (medical doctor [MD], registered nurse [RN], case manager), diagnostics (blood tests, vital signs, telemetry, x-ray, and ultrasound), intravenous therapy, and oxygen/nebulizer therapy will all be available for home hospital. Optional deployment of food services, home health aide, physical therapist, occupational therapist, and social worker will be tailored to patient need. Home hospital 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, activity tracking, and sleep tracking; Automated alerting of MDs by mobile phone for any worrisome vital sign patterns; On-demand 24/7 clinician video visits; 4 to 1 patient to attending MD ratio, compared to typical 16 to 1; Ambulatory/portable infusion pumps that can be worn on the hip; Optional access to a personal home health aide.

Should a matter be emergent (that is, requiring in-person assistance in less than 20 minutes), then 9-1-1 will be called and the patient will be returned to the hospital immediately. In previous iterations of home hospital this happens in about 2% of patients.

Clinical parameters measured will be at the discretion of the physician and nurse, who treat the participant following evidence-based practice guidelines, just as in the usual care setting. In addition, the investigators will be tracking a wide variety of measures of quality and safety, including some measures tailored to each primary diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 15, 2018
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Resides within either a 5-mile or 20 minute driving radius of emergency department

• Has capacity to consent to study OR can assent to study and has proxy who can consent

• >= 18 years-old

• 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 may be waived for highly competent patients at the patient and clinician's discretion.

• Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.

Exclusion Criteria:

• 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

• Acute delirium, as determined by the Confusion Assessment Method

• Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)

• Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage

• Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control

• Cannot independently ambulate to bedside commode

• As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery

• High risk for clinical deterioration

• Home hospital census is full (maximum 5 patients at any time)

Related Conditions & MeSH terms

• Anticoagulants; Increased
• Asthma
• Atrial Fibrillation
• Atrial Fibrillation Rapid
• Chronic Kidney Diseases
• COPD
• Gout Flare
• Heart Failure
• Hypertensive Urgency
• Infection
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Home hospitalization
See above
• Traditional inpatient hospitalization
See above

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Smiths Medical, Vital Connect

Country where clinical trial is conducted

United States, 

References & Publications (6)

Counsell SR, Holder CM, Liebenauer LL, Palmer RM, Fortinsky RH, Kresevic DM, Quinn LM, Allen KR, Covinsky KE, Landefeld CS. Effects of a multicomponent intervention 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 Dec;48(12):1572-81. — View Citation

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 Jun;31(6):1237-43. doi: 10.1377/hlthaff.2011.1132. — View Citation

Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24. Review. — View Citation

Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med. 2013 Jun 10;173(11):990-6. doi: 10.1001/jamainternmed.2013.478. — View Citation

Leff B, Burton L, Mader SL, Naughton B, Burl J, Inouye SK, Greenough WB 3rd, Guido S, Langston C, Frick KD, Steinwachs D, Burton JR. 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 Dec 6;143(11):798-808. — View Citation

Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total reimbursement, 30-day post discharge	Exploratory	Day of admission to 30-days post-discharge
Other	Intravenous medications, days	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Intravenous fluids, days	Exploratory; the number of days intravenous fluids (for example, normal saline) were received by the patient.	From date of admission to date of discharge, an expected average of 4 days
Other	Intravenous diuretics, days	Exploratory; the number of days intravenous diuretics (for example, furosemide) were received by the patient.	From date of admission to date of discharge, an expected average of 4 days
Other	Intravenous antibiotics, days	Exploratory; the number of days intravenous antibiotics (for example, ceftriaxone) were received by the patient.	From date of admission to date of discharge, an expected average of 4 days
Other	Supplemental oxygen required, days	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Nebulizer treatment, days	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Medical Doctor sessions, # notes	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Consultant sessions, # notes	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Physical therapy/occupational therapy sessions, # notes	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Primary care provider follow-up within 14 days, y/n	Exploratory	Day of discharge to 14 days later
Other	Skilled nursing facility utilization, days	Exploratory; the number of days a patient spent in a skilled nursing facility.	Day of discharge to 30 days later
Other	Home health utilization, days	Exploratory	Day of discharge to 30 days later
Other	Fall, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hospital-acquired deep vein thrombosis or pulmonary embolism, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hospital-acquired pressure ulcer, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hospital-acquired thrombophlebitis at peripheral IV site, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hospital-acquired catheter-associated urinary tract infection, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hospital-acquired Clostridium difficile infection, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	All-cause mortality, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Unplanned mortality, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Post-discharge all-cause mortality, y/n	Exploratory	Day of discharge to 30 days later
Other	Post-discharge unplanned mortality, y/n	Exploratory	Day of discharge to 30 days later
Other	New arrhythmia, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hypokalemia, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Acute Kidney Injury, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Mean Likert scale pain score, 0-10	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hours of sleep per night, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hours of activity per night, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Hours of sitting upright per night, #	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Pneumococcal vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Influenza vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Smoking cessation counseling if appropriate, y/n	Pneumonia and heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Evaluation of ejection fraction as assessed by echocardiogram or other appropriate study, scheduled or completed, if not done within 1 year; y/n	Heart failure patients only; Exploratory; Whether or not an appropriate study occurred and/or was scheduled if not done within 1 year; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography	From date of admission to date of discharge, an expected average of 4 days
Other	Angiotensin converting enzyme inhibitor or angiotensin receptor blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n	Heart failure patients only; Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Smoking status post-discharge; current/never/quit	Heart failure and pneumonia patients only; Exploratory; Self-report of smoking status: current/never/quit.	From date of admission to date of discharge, an expected average of 4 days
Other	Use of inappropriate medications in the elderly, y/n	Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria	From date of admission to date of discharge, an expected average of 4 days
Other	Use of Foley catheter, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	Use of restraints, y/n	Exploratory	From date of admission to date of discharge, an expected average of 4 days
Other	>3 medications added to medication list, y/n	Exploratory; comparison made between preadmission and discharge medication list	Date of discharge, an expected average of 4 days after the date of admission
Other	Patient health questionnaire-2, score	Exploratory	At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Other	Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score	Exploratory	At admission, at discharge (an expected average of 4 days after the date of admission), and at 30 days after discharge
Other	Days at home since discharge	Exploratory	30 days after discharge
Other	Walk around ward/home, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Other	Get to (non-commode) bathroom, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Other	Walk 1 flight of stairs, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Other	Visit with friends/family, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Other	Walk outside around my home, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Other	Go shopping, y/n	Exploratory	Date of discharge, an expected average of 4 days after the date of admission
Other	Time from admission decision to assessment by research assistant, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Other	Time from research assistant assessment to emergency department dismissal, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Other	Time from arrival home or to floor and medical doctor evaluation, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Other	Time from arrival home or to floor and registered nurse evaluation, minutes	Exploratory	On the first day of admission, a maximum 24 hour period
Other	Mean registered nurse to patient ratio	Exploratory, intervention arm only	From date of admission to date of discharge, an expected average of 4 days
Other	Total registered nurse visits, #	Exploratory, intervention arm only	From date of admission to date of discharge, an expected average of 4 days
Other	Total "on call" medical doctor interactions (video or phone), #	Exploratory, intervention arm only	From date of admission to date of discharge, an expected average of 4 days
Other	Total "on call" medical doctor in-person visits, #	Exploratory, intervention arm only	From date of admission to date of discharge, an expected average of 4 days
Other	Duration of 1st registered nurse visit, minutes	Exploratory, intervention arm only	On the first day of admission, a maximum 24 hour period
Other	Mean duration of subsequent registered nurse visit, minutes	Exploratory, intervention arm only	From date of admission to date of discharge, an expected average of 4 days
Primary	Total direct cost of hospitalization, $		From date of admission to date of discharge, an expected average of 4 days
Secondary	Direct margin, $	Direct margin from total cost of hospitalization	From date of admission to date of discharge, an expected average of 4 days
Secondary	Direct margin, modeled with backfill	Backfill uses a model that estimates the cost of patients who take the place of home hospital patients	From date of admission to date of discharge, an expected average of 4 days
Secondary	Total cost, 30-day post discharge		Day of admission to 30-days post-discharge
Secondary	Length of stay, days		From date of admission to date of discharge, an expected average of 4 days
Secondary	Imaging, #	Count of any diagnostic imaging (for example, x-ray, computed tomography, magnetic resonance, ultrasound, and nuclear imaging) that occurred through the course of the hospitalization.	From date of admission to date of discharge, an expected average of 4 days
Secondary	Lab orders, #	Count of any lab order (for example, basic metabolic panel, complete blood count, hepatic function panel) that occurred through the course of the hospitalization.	From date of admission to date of discharge, an expected average of 4 days
Secondary	All-cause readmission(s) after index, #		Day of discharge to 30 days later
Secondary	All-cause readmission(s) after index, y/n		Day of discharge to 30 days later
Secondary	Unplanned readmission(s) after index, #		Day of discharge to 30 days later
Secondary	Unplanned readmission(s) after index, y/n		Day of discharge to 30 days later
Secondary	Emergency Department observation stay(s) after index hospitalization, #		Day of discharge to 30 days later
Secondary	Emergency Department observation stay(s) after index hospitalization, y/n		Day of discharge to 30 days later
Secondary	Emergency Department visit(s) after index hospitalization, #		Day of discharge to 30 days later
Secondary	Emergency Department visit(s) after index hospitalization, y/n		Day of discharge to 30 days later
Secondary	Delirium, y/n		From date of admission to date of discharge, an expected average of 4 days
Secondary	Transfer back to hospital, y/n	Intervention arm only	From date of admission to date of discharge, an expected average of 4 days
Secondary	Hours of sleep per day, #		From date of admission to date of discharge, an expected average of 4 days
Secondary	Hours of activity per day, #		From date of admission to date of discharge, an expected average of 4 days
Secondary	Hours of sitting upright per day, #		From date of admission to date of discharge, an expected average of 4 days
Secondary	Steps per day, #		From date of admission to date of discharge, an expected average of 4 days
Secondary	EuroQol -5D-5L, composite score		At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Secondary	Short Form 1	1-5 Likert scale	30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Secondary	Activities of daily living, score		30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Secondary	Instrumental activities of daily living, score		30 days prior to admission (asked on day of admission), at admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge
Secondary	3-item Care Transition Measure, score		30 days after discharge
Secondary	Picker Experience Questionnaire, score		30 days after discharge
Secondary	Global satisfaction with care, score		30 days after discharge
Secondary	Qualitative interview		30 days after discharge