Pulmonary Disease, Chronic Obstructive Clinical Trial
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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|