Clinical trial NCT03028805: Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Early Patient Identification and Care Pathway for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial of Informatics Enhanced Hospital Admission
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Pulmonary Diseases, Obstructive
Keywords: Informatics
COPD
quality improvement
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a fully automated randomized trial with two randomization branch-points. The first is inclusion of disease-specific orders in the admission orders based on a predictive model using real-time data. The second is the use of dynamic orders that are end-user tested rather than static orders designed by a committee. The primary hypothesis is that automatic inclusion of disease specific orders with admission orders will improve adherence to guidelines for patients with COPD. The secondary hypothesis is that clinical and operational outcomes will improve, thereby improving value.

Detailed description: This is a single-center, single-blinded, 2x2 factorial randomized controlled trial to test both automated order set inclusion and evidence-based order set design with end user testing on order set use and clinical outcomes for adult patients admitted to the hospital with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

First, the investigators will develop a predictive model to identify patients admitted to the hospital with COPD exacerbations based on retrospective data, but limited to data that is available in real-time at admission.

Second, 1,000 admissions to UCSF Medical Center of adults predicted to have COPD by the predictive algorithm will be prospectively block randomized by encounter to automatic inclusion of a COPD order set in the admission orders or usual care. Providers caring for patients in both arms of the trial can independently search for and use a COPD order set. Any provider using a COPD order set in either arm will also be randomized to see two versions of the order set. The first is a static list of orders, and the second is dynamic, meaning that orders will display only when appropriate. For example, a patient who just had a chest x-ray does not need a routine repeat test. The dynamic order set will show the provider that the x-ray was completed at a specific time and will not display a prompt for a repeat test. Providers can, of course, still order anything they deem clinically appropriate, and may choose to order a repeat x-ray for a patient with a change in clinical status.

The components of the order set are based on international guidelines from the Global Initiative for Chronic Lung Disease (GOLD initiative, a collaboration between the National Heart, Lung, and Blood Institute and the World Health Organization) and a multi-stakeholder working group at UCSF including two hospitalists, two pulmonologists, two transitional care nurse specialists, one advanced practice nurse, one pharmacist, one respiratory therapist, one physical therapist, and one nurse.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or greater admitted to the Hospital Medicine service at UCSF Medical Center who meet criteria as determined by predictive model to be likely admissions for COPD exacerbation.

Exclusion Criteria:

* Patients admitted to other clinical services at UCSF Medical Center.

Primary outcomes:
measure: Use of evidence-based COPD order set
timeFrame: one year
Secondary outcomes:
measure: Average length of stay
timeFrame: one year
measure: Number of inpatient encounters
timeFrame: one year
measure: 30-day readmission rates
timeFrame: one year
measure: Mortality
timeFrame: one year
measure: Intubations
timeFrame: one year
measure: Code blue events
timeFrame: one year
measure: ICU admissions
timeFrame: one year
measure: Outpatient utilization
timeFrame: one year
measure: Discharge Disposition
timeFrame: one year
measure: Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.
timeFrame: one year
measure: Total costs of care
timeFrame: one year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ari Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References: