Anticoagulants; Increased, Asthma, Atrial Fibrillation Rapid, Chronic Kidney Diseases, Chronic Obstructive Pulmonary Disease, Gout Flare, Heart Failure, Hypertensive Urgency, Infection
Conditions
Keywords
home hospital, hospital at home, hospital in the home
Brief summary
This study examines the implications of providing hospital-level care in rural homes.
Detailed 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.
Interventions
OTHERHome hospital care
Patients receive hospital-level care in their home.
Sponsors
Rx Foundation
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients That Completed Their Rural Home Hospitalization | Day of admission to day of discharge, estimated 10 days later | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-item Care Transition Measure | Once, within Day of discharge to 7 days later | 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, ( scale of 1 to 12; where 12 indicates highest readiness to transition). The final score is calculated by calculating the sum or responses across the three items ((score Strongly Disagree = 1; Disagree = 2; Agree = 3; Strongly Agree = 4), the number of questions answers are counted, and then the mean response is then calculated (sum divided by count). |
| Picker Experience Questionnaire | Once, within Day of discharge to 7 days later | 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. Scale of 1-15, where a higher score indicates better patient experience. |
| Perceived Acceptability of RHH Care | Day of discharge to 30 days later | Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.The numbers in the data table reflect the number of patients and clinicians that perceived rural home hospital care to be acceptable. |
| Perceived Safety, Quality of Care, Caregiver Burden | Day of discharge to 30 days later | 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. The numbers in the data table reflect the number of patients and clinicians that perceived that rural home hospital was safe and that the care provided was of high quality. |
| Number of Rural Home Hospital Patients Escalated to Hospital for Care | Day of admission to day of discharge, estimated 10 days later | 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 |
| Global Satisfaction: Scale | Once, between Day of discharge to 7 days later | 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 |
| Number of Patients With Unplanned Mortality During Admission | Day of admission to day of discharge, estimated 10 days later | 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 |
| Lab Orders, Number | Day of admission to day of discharge, estimated 10 days later | Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records |
| Length of Stay | Day of admission to day of discharge, estimated 10 days later | 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. |
| Unplanned Readmission(s), Number or Patients | 30-days post-discharge | 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. |
| ED Visit(s), Number | 30-days post-discharge | Any Emergency Department (ED) visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient |
| Number of Patients With an Adverse Event | Day of admission to day of discharge, estimated 10 days later | Adverse events include Fall, Delirium, Potentially preventable Venous Thromboembolism (VTE), New pressure ulcer, Thrombophlebitis at peripheral intravenous line (IV) site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic |
Countries
United States
Participant flow
Recruitment details
A patient may be considered for Rural home hospital care if they are acutely ill at home, present acutely ill to a clinic or emergency department, or if they are admitted and require additional days of acute care. They must meet inclusion and exclusion criteria and be assessed for eligibility by the rural home hospital physician. Clinicians are any member of the rural home hospital clinical team that will be providing care to rural patients that enroll in the intervention.
Pre-assignment details
No significant event occurred after participant enrollment
Participants by arm
| Arm | Count |
|---|---|
| Patients Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
Home hospital care: Patients receive hospital-level care in their home. | 3 |
| Clinicians Clinicians that provide hospital-level care in a patient's home, as a substitute to traditional hospital care.
Home hospital care: Patients receive hospital-level care in their home. | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Clinicians | Total | Patients |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | — | 77 years STANDARD_DEVIATION 12 | 77 years STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | — | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | — | 3 Participants | 3 Participants |
| Region of Enrollment United States | — | 3 participants | 3 participants |
| Sex: Female, Male Female | — | 3 Participants | 3 Participants |
| Sex: Female, Male Male | — | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Day of admission to day of discharge, estimated 10 days later
Population: Three patients completed a rural home hospitalization. Rural home hospitalized patients were treated for their acute condition in rural home hospital.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Number of Patients That Completed Their Rural Home Hospitalization | 3 Participants |
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, ( scale of 1 to 12; where 12 indicates highest readiness to transition). The final score is calculated by calculating the sum or responses across the three items ((score Strongly Disagree = 1; Disagree = 2; Agree = 3; Strongly Agree = 4), the number of questions answers are counted, and then the mean response is then calculated (sum divided by count).
Time frame: Once, within Day of discharge to 7 days later
Population: Rural home hospitalized patients that completed the discharge survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | 3-item Care Transition Measure | 12 score on a scale | Standard Deviation 0 |
Secondary
ED Visit(s), Number
Any Emergency Department (ED) visits 30 days post-discharge from rural home hospital. Data to be collected by a research assistant via the patient
Time frame: 30-days post-discharge
Population: Patients that were home hospitalized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients | ED Visit(s), Number | 0 number of ED visits |
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
Time frame: Once, between Day of discharge to 7 days later
Population: Rural home hospitalized patients that completed the discharge survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | Global Satisfaction: Scale | 10 score on a scale | Standard Deviation 0 |
Secondary
Lab Orders, Number
Number of clinical lab orders. Data to be collected daily by a research assistant via rural home hospital records
Time frame: Day of admission to day of discharge, estimated 10 days later
Population: Patients that were home hospitalized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients | Lab Orders, Number | 0 lab orders |
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.
Time frame: Day of admission to day of discharge, estimated 10 days later
Population: Patients that were home hospitalized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | Length of Stay | 5.5 number of days | Standard Deviation 0.57 |
Secondary
Number of Patients With an Adverse Event
Adverse events include Fall, Delirium, Potentially preventable Venous Thromboembolism (VTE), New pressure ulcer, Thrombophlebitis at peripheral intravenous line (IV) site. Data to be collected daily by a research assistant via the Registered Nurse or Paramedic
Time frame: Day of admission to day of discharge, estimated 10 days later
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Number of Patients With an Adverse Event | 0 Participants |
Secondary
Number of Patients With 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
Time frame: Day of admission to day of discharge, estimated 10 days later
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Number of Patients With Unplanned Mortality During Admission | 0 Participants |
Secondary
Number of Rural Home Hospital Patients Escalated to Hospital for Care
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
Time frame: Day of admission to day of discharge, estimated 10 days later
Population: Three patients were enrolled in this study, these patients received the home hospital intervention. Patients receive hospital-level care in their home, as a substitute to traditional hospital care.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Number of Rural Home Hospital Patients Escalated to Hospital for Care | 0 Participants |
Secondary
Perceived Acceptability of RHH Care
Perceived acceptability will be assessed qualitatively through post-discharge semi-structured interviews with clinicians, patients, and caregivers.The numbers in the data table reflect the number of patients and clinicians that perceived rural home hospital care to be acceptable.
Time frame: Day of discharge to 30 days later
Population: Only one patient that completed home hospital hospitalization completed a qualitative interview post discharge therefore qualitative data was collected from only one patient. Four clinicians completed qualitative interviews and therefore qualitative data from four clinicians was analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Perceived Acceptability of RHH Care | 1 Participants |
| Clinicians | Perceived Acceptability of RHH Care | 4 Participants |
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. The numbers in the data table reflect the number of patients and clinicians that perceived that rural home hospital was safe and that the care provided was of high quality.
Time frame: Day of discharge to 30 days later
Population: One patient that completed home hospital hospitalization completed a qualitative interview post discharge therefore qualitative data was collected from only one patient. Four clinicians completed qualitative interviews
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Perceived Safety, Quality of Care, Caregiver Burden | 1 Participants |
| Clinicians | Perceived Safety, Quality of Care, Caregiver Burden | 4 Participants |
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. Scale of 1-15, where a higher score indicates better patient experience.
Time frame: Once, within Day of discharge to 7 days later
Population: Rural home hospitalized patients that completed the discharge survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | Picker Experience Questionnaire | 13 score on a scale | Standard Deviation 0 |
Secondary
Unplanned Readmission(s), Number or Patients
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.
Time frame: 30-days post-discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Unplanned Readmission(s), Number or Patients | 0 Participants |