Hospitalization at Home: The Acute Care Home Hospital Program for Adults

Heart Failure Clinical Trial

Official title:

Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864420
• Other study ID #: 2016P001337
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: July 7, 2017
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• 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;

• On-demand 24/7 clinician video visits;

• 4 to 1 patient to 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: 21
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Resides within 5-mile radius of emergency room

• English- or Spanish-speaker

• 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.

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

• >=18 years old

• Primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission as determined by blinded 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

• Cared for by a private primary care physician who rounds in the hospital

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

• Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage

• Primary diagnosis requires 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

• For pneumonia:

• Most recent CURB65 > 3: new confusion, blood urea nitrogen > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65

• Most recent SMRTCO > 2: systolic blood pressure < 90mmHg (2pts), multilobar chest xray involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90%

• Absence of clear infiltrate on imaging

• Cavitary lesion on imaging

• O2 saturation < 90% despite 5L O2

• For heart failure:

• Has a left ventricular assist device or paced rhythm

• Get with the Guidelines - Heart Failure (>10% in-hospital mortality) or The Acute Decompensated Heart Failure National Registry score (high risk or intermediate risk 1)

• Anasarca

• Pulmonary hypertension

• For complicated urinary tract infection:

• Absence of pyuria

• Most recent quick sepsis related organ failure assessment > 1

• Home hospital census is full (maximum 4 patients at any time)

Related Conditions & MeSH terms

• Cellulitis
• Heart Failure
• Pneumonia
• Urinary Tract Infections

Intervention

Other:
• Home hospitalization

• Inpatient Hospitalization

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 (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Partners HealthCare, Smiths Medical, ASD, Inc., Vital Connect, Inc.

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 cost of episode of care, $	Exploratory; Subset of sample for which claims data is available	Day of admission to 30 days after discharge
Other	Intraveneous medications, days	Exploratory	Day of admission to day of discharge
Other	Intraveneous fluids, days	Exploratory	Day of admission to day of discharge
Other	Intraveneous diuretics, days	Exploratory	Day of admission to day of discharge
Other	Intraveneous antibiotics, days	Exploratory	Day of admission to day of discharge
Other	Supplemental oxygen required, days	Exploratory	Day of admission to day of discharge
Other	Nebulizer treatment, days	Exploratory	Day of admission to day of discharge
Other	Medical Doctor sessions, # notes	Exploratory	Day of admission to day of discharge
Other	Consultant sessions, # notes	Exploratory	Day of admission to day of discharge
Other	Physical therapy/occupational therapy sessions, # notes	Exploratory	Day of admission to day of discharge
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	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	Day of admission to day of discharge
Other	Diagnosis of hospital-acquired or post-discharge deep vein thrombosis or pulmonary embolism	Exploratory	Day of admission to 30 days after discharge
Other	Hospital-acquired pressure ulcer, y/n	Exploratory	Day of admission to day of discharge
Other	Thrombophlebitis at peripheral intravenous site, y/n	Exploratory	Day of admission to day of discharge
Other	Catheter-associated urinary tract infection, y/n	Exploratory	Day of admission to day of discharge
Other	Clostridium difficile infection, y/n	Exploratory	Day of admission to day of discharge
Other	Methicillin resistant staph aureus infection, y/n	Exploratory	Day of admission to day of discharge
Other	Mortality during admission, y/n	Exploratory	Day of admission to day of discharge
Other	Post-discharge mortality, y/n	Exploratory	Day of discharge to 30 days later
Other	New arrhythmia, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Other	Hypokalemia, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Other	Acute kidney injury, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Other	Mean Likert scale pain score, 0-10	Exploratory	Day of admission to day of discharge
Other	Pneumococcal vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	Day of admission to day of discharge
Other	Influenza vaccination if appropriate, y/n	Pneumonia patients only; Exploratory	Day of admission to day of discharge
Other	Smoking cessation counseling if appropriate, y/n	Pneumonia and heart failure patients only; Exploratory	Day of admission to day of discharge
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; appropriate studies include cardiac magnetic resonance imaging, radionuclide ventriculography, single photon emission computed tomography myocardial perfusion imaging, or left ventriculography	Day of admission to day of discharge
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	Day of admission to day of discharge
Other	Beta blocker for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Other	Aldosterone antagonist for heart failure with reduced ejection fraction (ejection fraction < 40%), y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Other	Lipid lowering for coronary artery disease, peripheral vascular disease, cerebrovascular accident, or diabetes, y/n	Heart failure patients only; Exploratory	Day of admission to day of discharge
Other	Smoking status post-discharge	Heart failure and pneumonia patients only; Exploratory; current/never/quit.	30 days after day of discharge
Other	Use of inappropriate medications in the elderly, y/n	Exploratory; using Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) and Beers criteria	Day of admission to day of discharge
Other	Use of Foley catheter, y/n	Exploratory	Day of admission to day of discharge
Other	Use of restraints, y/n	Exploratory	Day of admission to day of discharge
Other	>3 medications added to medication list, y/n	Exploratory	Day of discharge (compared with preadmission med list)
Other	Patient health questionnaire-2, score	Exploratory	30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Other	Patient-Reported Outcomes Measurement Information System Emotional Support Short Form 4a, score	Exploratory	30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Other	Walk around ward/home, y/n	Exploratory	Day of discharge
Other	Get to (non-commode) bathroom, y/n	Exploratory	Day of discharge
Other	Walk 1 flight of stairs, y/n	Exploratory	Day of discharge
Other	Visit with friends/family, y/n	Exploratory	Day of admission to day of discharge
Other	Walk outside around my home, y/n	Exploratory	30 days after discharge
Other	Go shopping, y/n	Exploratory	30 days after discharge
Other	Time from admission decision to assessment by research assistant, minutes	Exploratory	Day of admission
Other	Time from research assistant assessment to emergency department dismissal, minutes	Exploratory	Day of admission
Other	Time from arrival home or to floor and medical doctor evaluation, minutes	Exploratory	Day of admission
Other	Time from arrival home or to floor and registered nurse evaluation, minutes	Exploratory	Day of admission
Other	Average Registered nurse to patient ratio	Exploratory	Day of admission to day of discharge
Other	Number of registered nurse visits, total	Exploratory	Day of admission to day of discharge
Other	Number of "on call" medical doctor interactions (video or phone), total	Exploratory, intervention arm only	Day of admission to day of discharge
Other	Number of "on call" medical doctor in-person visits, total	Exploratory, intervention arm only	Day of admission to day of discharge
Other	Duration of 1st registered nurse visit, minutes	Exploratory, intervention arm only	Day of admission
Other	Average Duration of subsequent registered nurse visit, minutes	Exploratory, intervention arm only	Day of admission to day of discharge
Primary	Total cost of hospitalization, $		Day of admission to day of discharge
Secondary	Direct margin, $	Direct margin from total cost of hospitalization	Day of admission to day of discharge
Secondary	Direct margin, modeled with backfill, $	Backfill uses a model that estimates the cost of patients who take the place of home hospital patients	Day of admission to day of discharge
Secondary	Length of stay, days		Day of admission to day of discharge
Secondary	Imaging, #		Day of admission to day of discharge
Secondary	Lab Orders, #		Day of admission to day of discharge
Secondary	Discharge Disposition	Routine, skilled nursing facility, home health, other	Day of discharge
Secondary	Readmission(s) after index hospitalization, y/n	Dichotomous outcome	Day of discharge to 30 days later
Secondary	Time to readmission after index hospitalization, days	Survival curve (hazard analysis)	Day of discharge to 30 days later
Secondary	Emergency Department (ED) observation stay(s) after index hospitalization, y/n	Dichotomous outcome	Day of discharge to 30 days later
Secondary	Time to ED observation stay(s) after index hospitalization, days	Survival curve (hazard analysis)	Day of discharge to 30 days later
Secondary	ED visit(s) after index hospitalization, y/n	Dichotomous outcome	Day of discharge to 30 days later
Secondary	Time to ED visit(s) after index hospitalization, days	Survival curve (hazard analysis)	Day of discharge to 30 days later
Secondary	Delirium, y/n		Day of admission to day of discharge
Secondary	Transfer back to hospital, y/n	intervention arm only	Day of admission to day of discharge
Secondary	Hours of sleep, #		Day of admission to day of discharge
Secondary	Daily steps, #		Day of admission to day of discharge
Secondary	EuroQol -5D-5L, composite score		At admission, at discharge, 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, 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, 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, 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