Rural Home Hospital: Proof of Concept

NCT04531280 | Completed Results

• 1 other identifier: 2020P000708
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection; Heart Failure; Chronic Obstructive Pulmonary Disease; Asthma; Gout Flare; Chronic Kidney Diseases; Hypertensive Urgency; Atrial Fibrillation Rapid; Anticoagulants; Increased

Keywords

home hospital; hospital at home; hospital in the home

Outcome Measures

Primary Outcomes (1)

• Number of Patients That Completed Their Rural Home Hospitalization

  Rural home hospital is when eligible rural patients receive hospital level care at home. This measure includes patients that were hospitalized in rural home hospital for treatment for their acute condition and were discharged from rural home hospital after their treatment was complete. The number in the data table reflects the number of patients that completed their home hospitalization.

  Day of admission to day of discharge, estimated 10 days later

Secondary Outcomes (12)

• 3-item Care Transition Measure

  Once, within Day of discharge to 7 days later

• Picker Experience Questionnaire

  Once, within Day of discharge to 7 days later

• Global Satisfaction: Scale

  Once, between Day of discharge to 7 days later

• Perceived Acceptability of RHH Care

  Day of discharge to 30 days later

• Perceived Safety, Quality of Care, Caregiver Burden

  Day of discharge to 30 days later

Study Arms (1)

Home hospital care

EXPERIMENTAL

Patients receive hospital-level care in their home, as a substitute to traditional hospital care

Other: Home hospital care

Interventions

Home hospital care OTHER

Patients receive hospital-level care in their home.

Home hospital care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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.
• 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.
• Age \>= 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Rx Foundation: collaborator

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Related Publications (13)

• 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.

  PMID: 23608775 BACKGROUND

• 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.

  PMID: 19347026 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11129745 BACKGROUND

• 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.

  PMID: 16330791 BACKGROUND

• 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.

  PMID: 22665835 BACKGROUND

• 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.

  PMID: 29411238 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31697657 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 8417639 BACKGROUND

• 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.

  PMID: 23549583 BACKGROUND

• 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.

  PMID: 21730240 BACKGROUND

MeSH Terms

Conditions

Infections; Heart Failure; Pulmonary Disease, Chronic Obstructive; Asthma; Renal Insufficiency, Chronic; Hypertensive Crisis

Interventions

Home Care Services, Hospital-Based

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Our study has limitations.1. We admitted three patients from two rural areas of Utah, limiting generalizability. Second, two out of three patients were lost to follow-up and did not complete a discharge survey or interview. These patients may have had experiences we did not capture.Third, given this was a small proof of concept, the technology systems were not integrated by design.

Results Point of Contact

• Title: Dr. David Levine
• Organization: Brigham and Women's Hospital

dmlevine@bwh.harvard.edu

6177328925

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. David Levine MD, MPH, MA

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 28, 2020
• Study Start: February 18, 2021
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)