- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526884
Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC) (NDC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
NDC is a hospital avoidance model with the potential to simultaneously improve the quality and safety of acute care, reduce costs, and address hospital/ED overcrowding. This novel hospital avoidance program will divert patients from the ED who have been diagnosed with the following conditions and meet certain clinical criteria:
- Diabetic Foot Infection/Osteomyelitis
- Cellulitis
- Congestive Heart Failure
- Syncope
- Pyelonephritis/Urinary Tract Infection
- Pneumonia
- Acute Kidney Infection
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90024
- Ronald Reagan UCLA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- About to be admitted through the ED for one of the NDC diagnoses or a synonym (per Study Protocol document), defined by the presence of a Plan to Admit order or Bed Request order, OR recently admitted under observation or inpatient status for one of the NDC diagnoses.
- Identified as at-risk for an avoidable hospitalization in the ED based on a pre-determined set of lab and vital parameters.
- Insurance that authorizes the patient to follow-up at UCLA Health, or self-pay
- Admitted or being admitted to an internal medicine service
Exclusion Criteria:
- Heart or lung transplant recipient with concern for graft dysfunction
- Pregnant
- Enrolled in hospice
- Admitted to a critical care service
- ED deems discharge unsafe due to complex social or medical factors
- Active malignant cancer (per Council of State and Territorial Epidemiologists value set)
- Pulmonary arterial hypertension (per Joint Commission value set)
- Undergoing workup for solid organ transplant
- Interstitial lung disease (including pulmonary fibrosis) (per Higher Level 7 value set)
- Requiring inpatient procedure or surgery defined by the presence of an anesthesia event or operating room encounter.
- The ED deems discharge unsafe due to complex social or medical factors.
- Transferred to an ineligible hospital
Note:
The Health System plans to limit the volume of referrals to the NDC by only referring patients who have an even birth date (this is more equitable than first-come-first-serve, because wage workers are more likely to come to the ED later in the day; even/odd birth date theoretically keeps more spots open for patients presenting to the ED later).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: ED-initiated hospitalization
Patients with odd birthdays will be routed to standard-of-care ED-initiated hospitalization pathways.
|
|
|
Experimental: Next Day Clinic
Patients with even birthdays who meet inclusion criteria will be given the option to receive care in the Next Day Clinic to avoid hospitalization.
|
A dedicated Next Day Clinic team consisting of a clinician and nurse case manager will provide care and specialist referrals to patients within 24 hours of an ED visit that would have resulted in hospitalization without this novel hospital avoidance initiative.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days alive and out of hospital (DAOH)
Time Frame: 30 days from index ED visit
|
Cumulative number of days alive and not admitted or boarding in a hospital or emergency department
|
30 days from index ED visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Financial analysis
Time Frame: Through study completion, an average of 12 months
|
Total cost per day of treatment
|
Through study completion, an average of 12 months
|
|
Cost effectiveness analysis
Time Frame: Through study completion, an average of 12 months
|
Total cost per day alive and out of hospital
|
Through study completion, an average of 12 months
|
|
Global health-related quality of life
Time Frame: 30 days from index ED visit
|
Composite PROMIS-29+2 score (patient reported outcome measurement information system).
PROMIS stands for Patient-Reported Outcomes Measurement Information System.
High scores mean more of the concept being measured.
|
30 days from index ED visit
|
|
Patient experience
Time Frame: 30 days from index ED visit
|
Measured by PSQ-18 (patient satisfaction questionnaire).
PSQ stands for Patient Satisfaction Questionnaire.
High scores indicate higher levels of satisfaction.
|
30 days from index ED visit
|
|
Hospitalizations avoided
Time Frame: Through study completion, an average of 12 months
|
Each NDC referral with a preceding Plan to Admit order or Bed Request order (regardless of treatment arm) will be considered an avoided hospitalization, given that the presence of one of these orders establishes that the counterfactual for NDC treatment in hospitalization.
|
Through study completion, an average of 12 months
|
|
Hospital bed-days saved
Time Frame: Through study completion, an average of 12 months
|
For each referral to the NDC, the number of hospital bed-days saved will be established by using the mean length of stay for patients treated per-protocol in the control condition matched for the same presenting illness.
|
Through study completion, an average of 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Bone Diseases
- Musculoskeletal Diseases
- Nervous System Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Connective Tissue Diseases
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Neurobehavioral Manifestations
- Inflammation
- Lung Diseases
- Bone Diseases, Infectious
- Renal Insufficiency
- Skin Diseases, Infectious
- Suppuration
- Nephritis
- Consciousness Disorders
- Unconsciousness
- Nephritis, Interstitial
- Pyelitis
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Heart Failure
- Acute Kidney Injury
- Pneumonia
- Syncope
- Osteomyelitis
- Cellulitis
- Pyelonephritis
Other Study ID Numbers
- 24-000913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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