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Information provided by:
Brigham and Women's Hospital
Last updated:
07/07/2021
Trial identifier:
NCT04531280
DisclaimerBrief summary:
This study examines the implications of providing hospital-level care in rural homes.
Detailed Description:
Glossary term:
Hospital-Level Care at Home for Acutely Ill Adults in Rural and Ultra-Rural Settings: Proof of Concept
Glossary term:
Interventional
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5
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Not Applicable
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2020P000708
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Other: Home hospital care
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Feb 18, 2021
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May 07, 2021
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May 07, 2021
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Aug 02, 2020
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Aug 26, 2020
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Aug 28, 2020
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Jul 06, 2021
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Jul 07, 2021
University of Utah Health
Salt Lake City, Utah, United States, 84132
Salt Lake City, Utah 84132
United States
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. For general information about clinical research, read Guides to Clinical Trials.
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18 Years +
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No
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All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Treatment
N/A
Single Group Assignment
1
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Experimental: Home hospital care
Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
Experimental: Home hospital care
Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
Other: Home hospital care
Patients receive hospital-level care in their home.
Other: Home hospital care
Patients receive hospital-level care in their home.
Glossary term:
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
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
Glossary term:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The Sponsor of a study is the organization or person that is conducting the study. They may provide resources needed to do the investigation.
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