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

NCT03028805 | Terminated

• 1 other identifier: 16-19504
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Diseases, Obstructive

Keywords

Informatics; COPD; quality improvement

Outcome Measures

Primary Outcomes (1)

• Use of evidence-based COPD order set

  Proportion of admissions for COPD exacerbation that use the COPD order set

  one year

Secondary Outcomes (11)

• Average length of stay

  one year

• Number of inpatient encounters

  one year

• 30-day readmission rates

  one year

• Mortality

  one year

• Intubations

  one year

Study Arms (4)

Usual care and order set A

NO INTERVENTION

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 and order set B

ACTIVE COMPARATOR

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.

Other: Dynamic, end-user order set design

Automatic inclusion and order set A

ACTIVE COMPARATOR

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

Other: Automatic inclusion of COPD orders in admission orders

Automatic inclusion and order set B

ACTIVE COMPARATOR

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

Other: Automatic inclusion of COPD orders in admission orders; Other: Dynamic, end-user order set design

Interventions

Automatic inclusion of COPD orders in admission orders OTHER

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.

Automatic inclusion and order set A; Automatic inclusion and order set B

Dynamic, end-user order set design OTHER

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.

Automatic inclusion and order set B; Usual care and order set B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ari Hoffman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 23, 2017
• Study Start: March 26, 2018
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Locations

US (1)