Pulmonary Disease, Chronic ObstructiveEPICPathNCT03028805
Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Automatic inclusion of COPD orders in admission orders and Dynamic, end-user order set design in people with Pulmonary Disease, Chronic Obstructive and Pulmonary Diseases, Obstructive, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Pulmonary Diseases, Obstructive
- What is being tested?
- Automatic inclusion of COPD orders in admission orders and Dynamic, end-user order set design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 23 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients admitted to other clinical services at UCSF Medical Center.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Being tested
- Automatic inclusion of COPD orders in admission orders, Dynamic, end-user order set design
- Keywords
- Informatics, COPD, quality improvement
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic inclusion of COPD orders in admission ordersOther
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.
Dynamic, end-user order set designOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Automatic inclusion of COPD orders in admission orders; Other: Dynamic, end-user order set design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of evidence-based COPD order set
Proportion of admissions for COPD exacerbation that use the COPD order set
Measured: one year
Secondary outcomes (11)
Average length of stay
Measured: one year
Number of inpatient encounters
Measured: one year
30-day readmission rates
Measured: one year
Mortality
Measured: one year
Intubations
Measured: one year
Code blue events
Measured: one year
ICU admissions
Measured: one year
Outpatient utilization
Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up
Measured: one year
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)
Measured: one year
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
Measured: one year
Total costs of care
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start26 Mar 2018
- Primary completion23 Jan 2019
- Study completion23 Jan 2019
Why it stopped: Trend toward increased readmissions in the auto-delivery arm.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Hoffman, University of California, San Francisco
- Investigators
- Ari Hoffman, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028805
- Sponsor's protocol ID
- 16-19504
- Acronym
- EPICPath
- Status last verified
- Jun 2019
- First submitted
- 4 Jan 2017
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03028805
- Acronym / sponsor ID
- EPICPath / 16-19504
- Keywords
- Informatics, COPD, quality improvement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trend toward increased readmissions in the auto-delivery arm.
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Dynamic, end-user order set designUsual 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. |
| Automatic inclusion and order set A | Active comparator | Other: Automatic inclusion of COPD orders in admission ordersCOPD order set is automatically included in admission orders as a static list. |
| Automatic inclusion and order set B | Active comparator | Other: Automatic inclusion of COPD orders in admission orders, Other: Dynamic, end-user order set designCOPD order set is automatically included in admission orders as a dynamic and end user tested version. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients admitted to other clinical services at UCSF Medical Center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic inclusion of COPD orders in admission ordersUse 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. | Other | Automatic inclusion and order set A, Automatic inclusion and order set B |
| Dynamic, end-user order set designUse 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. | Other | Automatic inclusion and order set B, Usual care and order set B |
Primary outcome
Use of evidence-based COPD order set
Time frame: one year
Proportion of admissions for COPD exacerbation that use the COPD order set
11 secondary outcomes
Average length of stay
Time frame: one year
Number of inpatient encounters
Time frame: one year
30-day readmission rates
Time frame: one year
Mortality
Time frame: one year
Intubations
Time frame: one year
Code blue events
Time frame: one year
ICU admissions
Time frame: one year
Outpatient utilization
Time frame: one year
Discharge Disposition
Time frame: one year
Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.
Time frame: one year
Total costs of care
Time frame: one year
Results and safety
The study was stopped early (reason given: Trend toward increased readmissions in the auto-delivery arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Hoffman, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic inclusion of COPD orders in admission orders and Dynamic, end-user order set design in people with Pulmonary Disease, Chronic Obstructive and Pulmonary Diseases, Obstructive, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Trend toward increased readmissions in the auto-delivery arm.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of evidence-based COPD order set (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.