PneumoniaNCT02864420
Hospitalization at Home: The Acute Care Home Hospital Program for Adults
A study testing Home hospitalization and Inpatient Hospitalization in people with Pneumonia and Heart Failure, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Heart Failure, Cellulitis
- What is being tested?
- Home hospitalization and Inpatient Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resides within 5-mile radius of emergency room
- English- or Spanish-speaker
- 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.
- This criterion may be waived for highly competent patients at the patient and clinician's discretion.
- >=18 years old
- Primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission as determined by blinded emergency room team.
Who cannot join
- 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
Show all 27Show fewer
- Cared for by a private primary care physician who rounds in the hospital
- Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
- Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
- Primary diagnosis requires narcotics for pain control
- Cannot independently ambulate to bedside commode
- As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
- For pneumonia:
- Most recent CURB65 > 3: new confusion, blood urea nitrogen > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65
- Most recent SMRTCO > 2: systolic blood pressure < 90mmHg (2pts), multilobar chest xray involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90%
- Absence of clear infiltrate on imaging
- Cavitary lesion on imaging
- O2 saturation < 90% despite 5L O2
- For heart failure:
- Has a left ventricular assist device or paced rhythm
- Get with the Guidelines - Heart Failure (>10% in-hospital mortality) or The Acute Decompensated Heart Failure National Registry score (high risk or intermediate risk 1)
- Anasarca
- Pulmonary hypertension
- For complicated urinary tract infection:
- Absence of pyuria
- Most recent quick sepsis related organ failure assessment > 1
- Home hospital census is full (maximum 4 patients at any time)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
Official title: Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.
Read the detailed description
Hospitals are the standard of care for acute illness in the United States, but hospital care is expensive and often unsafe, especially for older individuals. While admitted, 20% suffer delirium, over 5% contract hospital-acquired infections, and most lose functional status that is never regained. Timely access to inpatient care is poor: many hospital wards are typically over 100% capacity, and emergency department waits can be protracted. Moreover, hospital care is increasingly costly: many internal medicine admissions have a negative margin (i.e., expenditures exceed hospital revenues) and incur patient debt.
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, 20% reduced cost, and 20% improved patient experience. While this is the standard of care in several developed countries, only 2 non-randomized demonstration projects have been conducted in the United States, each with highly local needs. Taken together, home hospital evidence is promising but falls short due to non-robust experimental design, failure to implement modern medical technology, and poor enlistment of community support.
The home hospital module offers most of the same medical components that are standard of care in an acute care hospital. The typical staff (medical doctor [MD], registered nurse [RN], case manager), diagnostics (blood tests, vital signs, telemetry, x-ray, and ultrasound), intravenous therapy, and oxygen/nebulizer therapy will all be available for home hospital. Optional deployment of food services, home health aide, physical therapist, occupational therapist, and social worker will be tailored to patient need. Home hospital improves upon the components of a typical ward's standard of care in several ways:
- Point of care blood diagnostics (results at the bedside in <5 minutes);
- Minimally invasive continuous vital signs, telemetry, activity tracking, and sleep tracking;
- On-demand 24/7 clinician video visits;
- 4 to 1 patient to MD ratio, compared to typical 16 to 1;
- Ambulatory/portable infusion pumps that can be worn on the hip;
- Optional access to a personal home health aide
Should a matter be emergent (that is, requiring in-person assistance in less than 20 minutes), then 9-1-1 will be called and the patient will be returned to the hospital immediately. In previous iterations of home hospital this happens in about 2% of patients.
Clinical parameters measured will be at the discretion of the physician and nurse, who treat the participant following evidence-based practice guidelines, just as in the usual care setting. In addition, the investigators will be tracking a wide variety of measures of quality and safety, including some measures tailored to each primary diagnosis.
- Conditions
- Pneumonia, Heart Failure, Cellulitis, Urinary Tract Infections
- Being tested
- Home hospitalization, Inpatient Hospitalization
- Keywords
- home hospital, acute care home, care redesign, delivery innovation, heart failure, pneumonia, cellulitis, urinary tract infections
- Medical subject headings
- Pneumonia, Heart Failure, Cellulitis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home hospitalizationOther
Inpatient HospitalizationOther
| Study group | Role | What they receive |
|---|---|---|
| Inpatient hospitalization | Active comparator | Control / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vitals and activity monitor whose data is used only retrospectively. On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health. Receives: Other: Inpatient Hospitalization |
| Home hospitalization | Experimental | Intervention arm. Patients will return home after triage, diagnosis, and the beginning of treatment in the emergency department with a set of specialized patient-tailored services (listed above). On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health. Receives: Other: Home hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost of hospitalization, $
Measured: Day of admission to day of discharge
Secondary outcomes (24)
Direct margin, $
Direct margin from total cost of hospitalization
Measured: Day of admission to day of discharge
Direct margin, modeled with backfill, $
Backfill uses a model that estimates the cost of patients who take the place of home hospital patients
Measured: Day of admission to day of discharge
Length of stay, days
Measured: Day of admission to day of discharge
Imaging, #
Measured: Day of admission to day of discharge
Lab Orders, #
Measured: Day of admission to day of discharge
Discharge Disposition
Routine, skilled nursing facility, home health, other
Measured: Day of discharge
Readmission(s) after index hospitalization, y/n
Dichotomous outcome
Measured: Day of discharge to 30 days later
Time to readmission after index hospitalization, days
Survival curve (hazard analysis)
Measured: Day of discharge to 30 days later
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
Dichotomous outcome
Measured: Day of discharge to 30 days later
Time to ED observation stay(s) after index hospitalization, days
Survival curve (hazard analysis)
Measured: Day of discharge to 30 days later
ED visit(s) after index hospitalization, y/n
Dichotomous outcome
Measured: Day of discharge to 30 days later
Time to ED visit(s) after index hospitalization, days
Survival curve (hazard analysis)
Measured: Day of discharge to 30 days later
Delirium, y/n
Measured: Day of admission to day of discharge
Transfer back to hospital, y/n
intervention arm only
Measured: Day of admission to day of discharge
Hours of sleep, #
Measured: Day of admission to day of discharge
Daily steps, #
Measured: Day of admission to day of discharge
EuroQol -5D-5L, composite score
Measured: At admission, at discharge, and at 30 days after discharge
Short Form 1
1-5 Likert scale
Measured: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Activities of daily living, score
Measured: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Instrumental activities of daily living, score
Measured: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
3-item Care Transition Measure, score
Measured: 30 days after discharge
Picker Experience Questionnaire, score
Measured: 30 days after discharge
Global satisfaction with care, score
Measured: 30 days after discharge
Qualitative interview
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Partners HealthCare, Smiths Medical, ASD, Inc., Vital Connect, Inc.
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
- Investigators
- Jeffrey L Schnipper, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864420
- Sponsor's protocol ID
- 2016P001337
- Status last verified
- Jul 2017
- First submitted
- 3 Aug 2016
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16330791Cryer 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.
PubMed 22665835Hung 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.
PubMed 23608775Fong 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.
PubMed 19347026Counsell 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.
PubMed 11129745Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. doi: 10.5694/j.1326-5377.2010.tb04070.x.
PubMed 21077817Levine 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.
PubMed 29411238
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospitalization at Home Pilot: The Acute Care Home Hospital Program for Adults
- ClinicalTrials.gov ID
- NCT02864420
- Acronym / sponsor ID
- 2016P001337
- Conditions
- Pneumonia, Heart Failure, Cellulitis, Urinary Tract Infections
- Keywords
- home hospital, acute care home, care redesign, delivery innovation, heart failure, pneumonia, cellulitis, urinary tract infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Partners HealthCare, Smiths Medical, ASD, Inc., Vital Connect, Inc.
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.
Detailed description
Hospitals are the standard of care for acute illness in the United States, but hospital care is expensive and often unsafe, especially for older individuals. While admitted, 20% suffer delirium, over 5% contract hospital-acquired infections, and most lose functional status that is never regained. Timely access to inpatient care is poor: many hospital wards are typically over 100% capacity, and emergency department waits can be protracted. Moreover, hospital care is increasingly costly: many internal medicine admissions have a negative margin (i.e., expenditures exceed hospital revenues) and incur patient debt.
The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, 20% reduced cost, and 20% improved patient experience. While this is the standard of care in several developed countries, only 2 non-randomized demonstration projects have been conducted in the United States, each with highly local needs. Taken together, home hospital evidence is promising but falls short due to non-robust experimental design, failure to implement modern medical technology, and poor enlistment of community support.
The home hospital module offers most of the same medical components that are standard of care in an acute care hospital. The typical staff (medical doctor [MD], registered nurse [RN], case manager), diagnostics (blood tests, vital signs, telemetry, x-ray, and ultrasound), intravenous therapy, and oxygen/nebulizer therapy will all be available for home hospital. Optional deployment of food services, home health aide, physical therapist, occupational therapist, and social worker will be tailored to patient need. Home hospital improves upon the components of a typical ward's standard of care in several ways:
- Point of care blood diagnostics (results at the bedside in <5 minutes);
- Minimally invasive continuous vital signs, telemetry, activity tracking, and sleep tracking;
- On-demand 24/7 clinician video visits;
- 4 to 1 patient to MD ratio, compared to typical 16 to 1;
- Ambulatory/portable infusion pumps that can be worn on the hip;
- Optional access to a personal home health aide
Should a matter be emergent (that is, requiring in-person assistance in less than 20 minutes), then 9-1-1 will be called and the patient will be returned to the hospital immediately. In previous iterations of home hospital this happens in about 2% of patients.
Clinical parameters measured will be at the discretion of the physician and nurse, who treat the participant following evidence-based practice guidelines, just as in the usual care setting. In addition, the investigators will be tracking a wide variety of measures of quality and safety, including some measures tailored to each primary diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient hospitalization | Active comparator | Other: Inpatient HospitalizationControl / usual care arm. Patients are admitted per usual to an inpatient service. Patients' medical records will be closely monitored. Patients will wear a vitals and activity monitor whose data is used only retrospectively. On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health. |
| Home hospitalization | Experimental | Other: Home hospitalizationIntervention arm. Patients will return home after triage, diagnosis, and the beginning of treatment in the emergency department with a set of specialized patient-tailored services (listed above). On discharge and 30 days after discharge, they will be interviewed regarding their hospitalization and health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Resides within 5-mile radius of emergency room
- English- or Spanish-speaker
- 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.
- This criterion may be waived for highly competent patients at the patient and clinician's discretion.
- >=18 years old
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home hospitalization | Other | Home hospitalization |
| Inpatient Hospitalization | Other | Inpatient hospitalization |
Primary outcome
Total cost of hospitalization, $
Time frame: Day of admission to day of discharge
24 secondary outcomes
Direct margin, $
Time frame: Day of admission to day of discharge
Direct margin, modeled with backfill, $
Time frame: Day of admission to day of discharge
Length of stay, days
Time frame: Day of admission to day of discharge
Imaging, #
Time frame: Day of admission to day of discharge
Lab Orders, #
Time frame: Day of admission to day of discharge
Discharge Disposition
Time frame: Day of discharge
Readmission(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Time to readmission after index hospitalization, days
Time frame: Day of discharge to 30 days later
Emergency Department (ED) observation stay(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Time to ED observation stay(s) after index hospitalization, days
Time frame: Day of discharge to 30 days later
ED visit(s) after index hospitalization, y/n
Time frame: Day of discharge to 30 days later
Time to ED visit(s) after index hospitalization, days
Time frame: Day of discharge to 30 days later
Delirium, y/n
Time frame: Day of admission to day of discharge
Transfer back to hospital, y/n
Time frame: Day of admission to day of discharge
Hours of sleep, #
Time frame: Day of admission to day of discharge
Daily steps, #
Time frame: Day of admission to day of discharge
EuroQol -5D-5L, composite score
Time frame: At admission, at discharge, and at 30 days after discharge
Short Form 1
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Activities of daily living, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
Instrumental activities of daily living, score
Time frame: 30 days prior to admission (asked on day of admission), at admission, at discharge, and at 30 days after discharge
3-item Care Transition Measure, score
Time frame: 30 days after discharge
Picker Experience Questionnaire, score
Time frame: 30 days after discharge
Global satisfaction with care, score
Time frame: 30 days after discharge
Qualitative interview
Time frame: 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 16330791Leff 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.
- Background: PubMed 22665835Cryer 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.
- Background: PubMed 23608775Hung 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.
- Background: PubMed 19347026Fong 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.
- Background: PubMed 11129745Counsell 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.
- Background: PubMed 21077817Montalto M. The 500-bed hospital that isn't there: the Victorian Department of Health review of the Hospital in the Home program. Med J Aust. 2010 Nov 15;193(10):598-601. doi: 10.5694/j.1326-5377.2010.tb04070.x.
- Derived from this study: PubMed 29411238Levine 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Schnipper, MD, MPH principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home hospitalization and Inpatient Hospitalization in people with Pneumonia and Heart Failure, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cost of hospitalization, $ (time frame: Day of admission to day of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02864420, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.