Rural Home Hospital: Proof of Concept

Asthma Clinical Trial

Official title:

Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531280
• Other study ID #: 2020P000708
• Status: Completed
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: May 7, 2021

Study information

• Verified date: July 2021
• 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 care 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 further improve the model, the investigators propose to determine the feasibility of home hospital care in a rural home setting through a proof-of-concept approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: 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.

Patient social inclusion criteria:

• 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.

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

• Age >= 18 years old

• Has capacity to consent to study

• Lives with or nearby to patient

Clinician inclusion criteria: Any member of the rural home hospital (RHH) clinical team (MD, RN, paramedic, NP) who will be participating in the screening and recruitment of patients for the rural home hospital intervention and/or providing care to rural patients that enroll in the intervention.

Patient Clinical Exclusion Criteria:

• 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

• For patients with end-stage renal disease on peritoneal dialysis: Peritoneal catheter malfunction; Requires temporary hemodialysis

• Home hospital census is full (maximum 3 patients at any time)

• 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 social exclusion criteria:

• Non-english speaking

• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	RxFoundation

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

Creditor MC. Hazards of hospitalization of the elderly. Ann Intern Med. 1993 Feb 1;118(3):219-23. Review. — 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

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. — 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

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 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rural home hospitalization accomplished	Completion of rural home hospitalization using a checklist to assess process completion on a scale of excellent, very good, good, fair, poor or does not apply.	Day of admission to day of discharge, estimated 10 days later
Secondary	3-item Care Transition Measure	This is a hospital level measure of performance that reports the average patient reported quality of preparation for self-care response among adult patients discharged from general acute care hospitals. Data will be collected by a Research Assistant via patient	Day of discharge to 7 days later
Secondary	Picker Experience Questionnaire	The Picker Patient Experience Questionnaire is a fifteen item questionnaire covering eight domains including information & education and coordination of care. The questionnaire is used to measure patient experience with in-patient care. The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1). A problem is defined as any aspect of health care that could be improved upon. Data will be collected by a research assistant via patient	Day of discharge to 7 days later
Secondary	Global satisfaction: scale	Measure of patient experience and satisfaction with care using any number from 0 to 10, where 0 is the worst hospital possible and 10 is the best hospital possible. Data will be collected by a Research Assistant via patient	Day of discharge to 7 days later
Secondary	Perceived acceptability of RHH care	Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.	Day of discharge to 30 days later
Secondary	Perceived safety, quality of care, caregiver burden	Perceived safety, quality of care, caregiver burden will be assessed qualitatively through one post-discharge semi-structured interview with each participating clinician, patient, and caregiver.	Day of discharge to 30 days later
Secondary	Escalation of care to hospital	If enrolled patient must be discharged from rural home hospital and taken to an acute-care hospital for care. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic	Day of admission to day of discharge, estimated 10 days later
Secondary	Adverse event	Adverse events include Fall, Delirium, Potentially preventable VTE, New pressure ulcer, Thrombophlebitis at peripheral IV site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic	Day of admission to day of discharge, estimated 10 days later
Secondary	Unplanned mortality during admission	Any case of unplanned death among enrolled rural home hospital patient.Data to be collected daily by a research assistant via the Registered Nurse or Paramedic	Day of admission to day of discharge, estimated 10 days later
Secondary	Lab Orders, number	Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records	Day of admission to day of discharge, estimated 10 days later
Secondary	Length of stay	The number of days enrolled patient is admitted to rural home hospital.Data to be collected daily by a research assistant via rural home hospital records	Day of admission to day of discharge, estimated 10 days later
Secondary	Unplanned readmission(s) after index, number and yes or no	Unplanned readmission of patient to hospital 30 days post discharge from rural home hospital. Data to be collected by a research assistant via the patient.	30-days post-discharge
Secondary	ED visit(s) after index, number and yes or no	Any ED visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient	30-days post-discharge