Rural Hospital-Level Care at Home for Acutely Ill Adults

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256303
• Other study ID #: 2021P000334
• Status: Completed
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: January 17, 2024

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Home hospital 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 determine the effect of home hospital care in rural homes, the investigators propose to the following randomized control trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 17, 2024
• Est. primary completion date: December 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Gout exacerbation

• Chronic kidney disease with volume overload

• Hypertensive urgency

• End of life / desires only medical management

Patient environmental inclusion criteria:

• Lives in a rural area that can be served by the RHH team.

• Has capacity to consent to study OR can assent to study and has proxy who can consent (see subject enrollment, below)

• 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.

Patient caregiver inclusion criteria: (not required for patient participation):

• Age >= 18 years old

• Has capacity to consent to study

• Lives within 15 minutes travel time.

Clinician inclusion criteria:

• The rural home hospital clinical team will be identified by the site PI at each study site prior to the start of the study. The site PI will recruit local RNs and/or EMT-Ps, and attending physicians (MD) to deploy and provide rural home hospital care.

• Any member of the rural home hospital clinical team (a clinician providing care in the home) who will be participating in research activities, including the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.

Sites without continuous monitoring will make amendments to the above inclusion criteria

Exclusion Criteria:

• Patient exclusion clinical criteria:

• Acute delirium, as determined by the Confusion Assessment Method

• Cannot establish peripheral access by any means

• Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage (unless part of end of life pathway)

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

• Cannot independently ambulate to bedside commode, unless home-based aides are available

• 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 (unless these can be coordinated with appropriate facilities during the home hospitalization)

• 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)15

• 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

• 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)19

• For other infection

• Most recent qSOFA > 1 (SBP=100 mmHg, RR=22, GCS<15 [any AMS]) (if sepsis, >10% mortality)19

• For COPD

• 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

• 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

• Home hospital census is full

• 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 environmental 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

Sites without continuous monitoring will make amendments to the above exclusion criteria

Related Conditions & MeSH terms

• Anticoagulation
• Asthma
• Atrial Fibrillation
• Atrial Fibrillation Rapid
• Chronic Kidney Diseases
• Chronic Obstructive Pulmonary Disease
• Death
• Gout Flare
• Heart Failure
• Hypertensive Crisis
• Hypertensive Urgency
• Infections
• Kidney Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic

Intervention

Other:
• Home Hospital care
Patients receive hospital-level care in their home
• Traditional Hospital care
Patients receive hospital-level care in the hospital.

Locations

Country	Name	City	State
Canada	Wetaskiwin Hospital and Care Centre	Wetaskiwin	Alberta
United States	Appalachian Regional Healthcare, Inc.	Hazard	Kentucky
United States	Blessing Health System	Quincy	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	The Thompson Family Foundation Inc

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (14)

2014 National and State Healthcare-Associated Infections Progress Report.; 2016. http://www.cdc.gov/hai/surveillance/progress-report/index.html. Accessed April 19, 2016.

Bureau UC. What is Rural America?https://www.census.gov/library/stories/2017/08/rural-america.html. Published 2017. Accessed May 31, 2019.

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. doi: 10.1111/j.1532-5415.2000.tb03866.x. — View Citation

Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. doi: 10.7326/0003-4819-118-3-199302010-00011. — 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. — View Citation

Garcia MC, Rossen LM, Bastian B, Faul M, Dowling NF, Thomas CC, Schieb L, Hong Y, Yoon PW, Iademarco MF. Potentially Excess Deaths from the Five Leading Causes of Death in Metropolitan and Nonmetropolitan Counties - United States, 2010-2017. MMWR Surveill Summ. 2019 Nov 8;68(10):1-11. doi: 10.15585/mmwr.ss6810a1. — 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

Joynt KE, Harris Y, Orav EJ, Jha AK. Quality of care and patient outcomes in critical access rural hospitals. JAMA. 2011 Jul 6;306(1):45-52. doi: 10.1001/jama.2011.902. — View Citation

Joynt KE, Orav EJ, Jha AK. Mortality rates for Medicare beneficiaries admitted to critical access and non-critical access hospitals, 2002-2010. JAMA. 2013 Apr 3;309(13):1379-87. doi: 10.1001/jama.2013.2366. — 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. doi: 10.7326/0003-4819-143-11-200512060-00008. — View Citation

Levine DM, Ouchi K, Blanchfield B, Diamond K, Licurse A, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial. J Gen Intern Med. 2018 May;33(5):729-736. doi: 10.1007/s11606-018-4307-z. Epub 2018 Feb 6. — View Citation

Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	IV medication, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Intravenous fluids, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Intravenous diuretics, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Intravenous antibiotics, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Oxygen requirement, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Nebulizer treatment, days	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Imaging, %	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Lab orders, #	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	MD sessions, # of notes	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Consultant sessions, # of notes	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	PT/OT sessions, # of notes	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Frequency of disposition, routine, SNF, home health, other	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Follow up with patient's PCP within 14 days, y/n	Exploratory	Up to 30 days from day of discharge, assessed up to 2 months
Other	SNF utilization, days	Exploratory	Up to 30 days from day of discharge, assessed up to 2 months
Other	Home health utilization, days	Exploratory	Up to 30 days from day of discharge, assessed up to 2 months
Other	Unplanned readmission(s) after index, # and y/n + date	Exploratory	Up to 30 days from day of discharge, assessed up to 2 months
Other	ED observation stay(s), # and y/n + date	Exploratory	Up to 30 days from day of discharge, assessed up to 2 months
Other	ED visit(s), # and y/n + date	Exploratory	Up to 30 days from day of discharge, assessed up to 2 months
Other	Fall, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Delirium, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	DVT/PE, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	New pressure ulcer, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Thrombophlebitis at peripheral IV site, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hospital-acquired catheter-associated urinary tract infection, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hospital-acquired Clostridium difficile infection, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hospital-acquired methicillin resistant staphylococcus aureus infection, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	New arrhythmia, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hypokalemia, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Acute kidney injury, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Medication error, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Unanticipated mortality, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Loss of consciousness, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Transfer back to hospital, y/n	Intervention arm only; Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Unplanned mortality during admission	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Unplanned 30-day mortality	Exploratory	Day of discharge to 30-days post discharge, assessed up to 2 months
Other	Pain management, mean pain score on a scale from 0-10 where 10 is the worst pain imaginable	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hours of sleep per day	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hours of sleep per night	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hours of activity per day	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hours of activity per night	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hours of sitting upright per day	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Hours of sitting upright per night	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Daily steps	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Use of inappropriate medications in the elderly, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Use of Foley catheter, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Use of restraints, y/n	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	EuroQol-5D-5L, visual analogue scale, 0-100, where 100 is the best imaginable health today	Exploratory	At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Other	SF-1	Exploratory; 1-5 Likert scale: Excellent, very good, good, fair poor	At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Other	Activities of daily living, score	Exploratory	At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Other	Instrumental activities of daily living, score	Exploratory	At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Other	Patient health questionnaire-2, score	Exploratory	At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Other	PROMIS Emotional Support Short Form 4a, score	Exploratory; I have someone who will listen to me when I need to talk I have someone to confide in or talk to about myself or my problems I have someone who makes me feel appreciated I have someone to talk with when I have a bad day Scale for each: never, rarely, sometimes, usually, always	At admission, at discharge (the day the patient leaves the hospital environment), and at 30 days after discharge, each assessed up to 2 months
Other	Picker Experience Questionnaire -15, score, measured 0-15, where 15 is the best patient experience	Exploratory	Within 30 days after discharge, assessed up to 2 months
Other	Global satisfaction with care, score, 0-10, where 10 is the best global satisfaction	Exploratory	Within 30 days after discharge, assessed up to 2 months
Other	Recommend care, score, 0-10, where 10 is the best recommendation possible	Exploratory	Within 30 days after discharge, assessed up to 2 months
Other	Qualitative interview	Exploratory	Day of discharge to 30 days after discharge, assessed up to 2 months
Other	Caregiver burden (Zarit), 0-48, where 48 indicates the worst possible caregiver burden	Exploratory	Day of admission and within 30 days after discharge, assessed up to 2 months
Other	Number of RN visits, in-person	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Number of RN visits, virtual	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Number of RN visits, total	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	RN travel time	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Failed connectivity, %	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Number of "on call" MD interactions (video or phone)	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Duration of 1st RN visit	Exploratory	Day of admission, assessed up to 2 months
Other	Duration of subsequent RN visit, in-person	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Duration of subsequent RN visit, virtual	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Other metrics captured on the clinician process survey and nursing visit form	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Insufficient handoff	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Documentation error	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Equipment malfunction	Exploratory	Day of admission to day of discharge, assessed up to 2 months
Other	Age	Exploratory	Day of admission, assessed up to 2 months
Other	Gender	Exploratory	Day of admission, assessed up to 2 months
Other	Race/ethnicity	Exploratory	Day of admission, assessed up to 2 months
Other	Primary language	Exploratory	Day of admission, assessed up to 2 months
Other	Health insurance states, public/private/none	Exploratory	Day of admission, assessed up to 2 months
Other	BMI	Exploratory	Day of admission, assessed up to 2 months
Other	Comorbidities, type and #	Exploratory	Day of admission, assessed up to 2 months
Other	Partner status	Exploratory	Day of admission, assessed up to 2 months
Other	Education	Exploratory	Day of admission, assessed up to 2 months
Other	Zip code	Exploratory	Day of admission, assessed up to 2 months
Other	Employment	Exploratory	Day of admission, assessed up to 2 months
Other	Smoking status	Exploratory	Day of admission, assessed up to 2 months
Other	Medications used as outpatient, #	Exploratory	Day of admission, assessed up to 2 months
Other	DNR/I code status	Exploratory	Day of admission, assessed up to 2 months
Other	Lives alone	Exploratory	Day of admission, assessed up to 2 months
Other	Home health aide prior to admission	Exploratory	Day of admission, assessed up to 2 months
Other	Elective and urgent admissions in the previous year, #	Exploratory	Day of admission, assessed up to 2 months
Other	ED visits in the previous 6 months, #	Exploratory	Day of admission, assessed up to 2 months
Other	Interqual disease-specific leveling	Exploratory	Day of admission, assessed up to 2 months
Other	PRISMA-7	Exploratory	Day of admission, assessed up to 2 months
Other	Eight-item Interview to Differentiate Aging and Dementia	Exploratory	Day of admission, assessed up to 2 months
Other	Would you be surprised if this patient died in the next year?	Exploratory	Day of admission, assessed up to 2 months
Other	BRIEF health literacy screening tool	Exploratory	Day of admission, assessed up to 2 months
Other	Readmission risk score on discharge (HOSPITAL)	Exploratory	Day of discharge, assessed up to 2 months
Other	Admitting diagnosis	Exploratory	Day of admission, assessed up to 2 months
Other	Admission source	Exploratory	Day of admission, assessed up to 2 months
Other	COVID case count on day of admission	Exploratory	Day of admission, assessed up to 2 months
Other	Degree of rurality	Exploratory	Day of admission, assessed up to 2 months
Other	[intervention arm only] RHH admission, daily care, and discharge processes accomplished	Exploratory	Twice a week, day of enrollment to day of final discharge, assessed up to 2 months
Other	[intervention arm only] Perceived acceptability of RHH care	Exploratory	Day of discharge to 30 days postdischarge, assessed up to 2 months
Other	[intervention arm only] Perceived safety, quality of care, caregiver burden	Exploratory	Day of discharge to 30 days, assessed up to 2 months
Other	Qualitative interviews	Interviews with patients, caregivers, and rural home hospital clinicians.	Day of enrollment to day of final discharge, assessed up to 4 months
Primary	Total cost, hospitalization	Published as percent change given sensitivity of these data	Date of admission to date of discharge, estimated 10 days later
Secondary	Total cost, discharge to 30-days post discharge	Published as percent change given sensitivity of these data	Day of discharge to 30 days later
Secondary	Unplanned readmission within 30-days of discharge	Percentage	Day of discharge to 30 days later
Secondary	Days at home	The number of days spent at home from the day of discharge to 30-days later	Day of discharge to 30 days later
Secondary	Percent of day lying down		Day of admission to day of discharge, assessed up to 2 months