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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Pulmonary Diseases, Obstructive

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automatic inclusion of COPD orders in admission orders
Dynamic, end-user order set design
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Informatics, COPD, quality improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Usual care and order set A

Usual care and order set B

Automatic inclusion and order set A

Automatic inclusion and order set B

Arm Description

Usual care. Providers may still search for a COPD order set, and in this arm will see version A, the static list of orders, which is the current state.

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.

COPD order set is automatically included in admission orders as a static list.

COPD order set is automatically included in admission orders as a dynamic and end user tested version.

Outcomes

Primary Outcome Measures

Use of evidence-based COPD order set
Proportion of admissions for COPD exacerbation that use the COPD order set

Secondary Outcome Measures

Average length of stay
Number of inpatient encounters
30-day readmission rates
Mortality
Intubations
Code blue events
ICU admissions
Outpatient utilization
Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up
Discharge Disposition
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)
Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.
ICD-10 codes as described by PRIME program, California's Medicaid 1115 Waiver
Total costs of care

Full Information

First Posted
January 4, 2017
Last Updated
June 15, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03028805
Brief Title
Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
EPICPath
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Trend toward increased readmissions in the auto-delivery arm.
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
January 23, 2019 (Actual)
Study Completion Date
January 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Pulmonary Diseases, Obstructive
Keywords
Informatics, COPD, quality improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care and order set A
Arm Type
No Intervention
Arm Description
Usual care. Providers may still search for a COPD order set, and in this arm will see version A, the static list of orders, which is the current state.
Arm Title
Usual care and order set B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Automatic inclusion and order set A
Arm Type
Active Comparator
Arm Description
COPD order set is automatically included in admission orders as a static list.
Arm Title
Automatic inclusion and order set B
Arm Type
Active Comparator
Arm Description
COPD order set is automatically included in admission orders as a dynamic and end user tested version.
Intervention Type
Other
Intervention Name(s)
Automatic inclusion of COPD orders in admission orders
Intervention Description
Use of real-time data to identify a population of patients with COPD and prompt improved adherence to evidence-based guidelines through the automatic inclusion of a COPD order set in the admission orders.
Intervention Type
Other
Intervention Name(s)
Dynamic, end-user order set design
Intervention Description
Use of a dynamic order set that has been end-user tested prior to launch rather than designed centrally by a committee to test use of order set components.
Primary Outcome Measure Information:
Title
Use of evidence-based COPD order set
Description
Proportion of admissions for COPD exacerbation that use the COPD order set
Time Frame
one year
Secondary Outcome Measure Information:
Title
Average length of stay
Time Frame
one year
Title
Number of inpatient encounters
Time Frame
one year
Title
30-day readmission rates
Time Frame
one year
Title
Mortality
Time Frame
one year
Title
Intubations
Time Frame
one year
Title
Code blue events
Time Frame
one year
Title
ICU admissions
Time Frame
one year
Title
Outpatient utilization
Description
Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up
Time Frame
one year
Title
Discharge Disposition
Description
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)
Time Frame
one year
Title
Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.
Description
ICD-10 codes as described by PRIME program, California's Medicaid 1115 Waiver
Time Frame
one year
Title
Total costs of care
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Hoffman, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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