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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05256303
Other study ID # 2021P000334
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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 allClick 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
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