Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT02864420
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02864420
Study Brief:
Protocol Section:
NCT02864420