Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Terminated

• Conditions: Pulmonary Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Automatic inclusion of COPD orders in admission orders; Other: Dynamic, end-user order set design

• Registration Number: NCT03028805
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-23
• Study Start: 2018-03-26
• Primary Completion: 2019-01-23
• Study Completion: 2019-01-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-15
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 310

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Automatic inclusion and order set A	Automatic inclusion of COPD orders in admission orders	COPD order set is automatically included in admission orders as a static list.
Automatic inclusion and order set B	Automatic inclusion of COPD orders in admission orders	COPD order set is automatically included in admission orders as a dynamic and end user tested version.
Automatic inclusion and order set B	Dynamic, end-user order set design	COPD order set is automatically included in admission orders as a dynamic and end user tested version.
Usual care and order set B	Dynamic, end-user order set design	Usual care in the sense that COPD orders are not automatically included in admission orders despite likelihood of a COPD admission based on the predictive model. However, providers may still search for a COPD order set, and in this arm will see version B, the dynamic list of orders that has been end user tested prior to launch.

Primary Outcome Measures

Name	Time	Method
Use of evidence-based COPD order set	one year	Proportion of admissions for COPD exacerbation that use the COPD order set

Secondary Outcome Measures

Name	Time	Method
Average length of stay	one year
Number of inpatient encounters	one year
30-day readmission rates	one year
Mortality	one year
Intubations	one year
Code blue events	one year
ICU admissions	one year
Outpatient utilization	one year	Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up
Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.	one year	ICD-10 codes as described by PRIME program, California's Medicaid 1115 Waiver
Total costs of care	one year
Discharge Disposition	one year	Proportion of patients discharged to home, home with home health services, or to a facility (includes skilled nursing, acute rehabilitation, sub-acute, long term acute care, and other acute care facilities)

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States