<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03028805</url>
  </required_header>
  <id_info>
    <org_study_id>16-19504</org_study_id>
    <nct_id>NCT03028805</nct_id>
  </id_info>
  <brief_title>Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <acronym>EPICPath</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a fully automated randomized trial with two randomization branch-points. The first is&#xD;
      inclusion of disease-specific orders in the admission orders based on a predictive model&#xD;
      using real-time data. The second is the use of dynamic orders that are end-user tested rather&#xD;
      than static orders designed by a committee. The primary hypothesis is that automatic&#xD;
      inclusion of disease specific orders with admission orders will improve adherence to&#xD;
      guidelines for patients with COPD. The secondary hypothesis is that clinical and operational&#xD;
      outcomes will improve, thereby improving value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, single-blinded, 2x2 factorial randomized controlled trial to test&#xD;
      both automated order set inclusion and evidence-based order set design with end user testing&#xD;
      on order set use and clinical outcomes for adult patients admitted to the hospital with acute&#xD;
      exacerbations of Chronic Obstructive Pulmonary Disease (COPD).&#xD;
&#xD;
      First, the investigators will develop a predictive model to identify patients admitted to the&#xD;
      hospital with COPD exacerbations based on retrospective data, but limited to data that is&#xD;
      available in real-time at admission.&#xD;
&#xD;
      Second, 1,000 admissions to UCSF Medical Center of adults predicted to have COPD by the&#xD;
      predictive algorithm will be prospectively block randomized by encounter to automatic&#xD;
      inclusion of a COPD order set in the admission orders or usual care. Providers caring for&#xD;
      patients in both arms of the trial can independently search for and use a COPD order set. Any&#xD;
      provider using a COPD order set in either arm will also be randomized to see two versions of&#xD;
      the order set. The first is a static list of orders, and the second is dynamic, meaning that&#xD;
      orders will display only when appropriate. For example, a patient who just had a chest x-ray&#xD;
      does not need a routine repeat test. The dynamic order set will show the provider that the&#xD;
      x-ray was completed at a specific time and will not display a prompt for a repeat test.&#xD;
      Providers can, of course, still order anything they deem clinically appropriate, and may&#xD;
      choose to order a repeat x-ray for a patient with a change in clinical status.&#xD;
&#xD;
      The components of the order set are based on international guidelines from the Global&#xD;
      Initiative for Chronic Lung Disease (GOLD initiative, a collaboration between the National&#xD;
      Heart, Lung, and Blood Institute and the World Health Organization) and a multi-stakeholder&#xD;
      working group at UCSF including two hospitalists, two pulmonologists, two transitional care&#xD;
      nurse specialists, one advanced practice nurse, one pharmacist, one respiratory therapist,&#xD;
      one physical therapist, and one nurse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Trend toward increased readmissions in the auto-delivery arm.&#xD;
  </why_stopped>
  <start_date type="Actual">March 26, 2018</start_date>
  <completion_date type="Actual">January 23, 2019</completion_date>
  <primary_completion_date type="Actual">January 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Use of evidence-based COPD order set</measure>
    <time_frame>one year</time_frame>
    <description>Proportion of admissions for COPD exacerbation that use the COPD order set</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average length of stay</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of inpatient encounters</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day readmission rates</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubations</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Code blue events</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU admissions</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient utilization</measure>
    <time_frame>one year</time_frame>
    <description>Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Disposition</measure>
    <time_frame>one year</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.</measure>
    <time_frame>one year</time_frame>
    <description>ICD-10 codes as described by PRIME program, California's Medicaid 1115 Waiver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total costs of care</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">310</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Pulmonary Diseases, Obstructive</condition>
  <arm_group>
    <arm_group_label>Usual care and order set A</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care and order set B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automatic inclusion and order set A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>COPD order set is automatically included in admission orders as a static list.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automatic inclusion and order set B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>COPD order set is automatically included in admission orders as a dynamic and end user tested version.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Automatic inclusion of COPD orders in admission orders</intervention_name>
    <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.</description>
    <arm_group_label>Automatic inclusion and order set A</arm_group_label>
    <arm_group_label>Automatic inclusion and order set B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dynamic, end-user order set design</intervention_name>
    <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.</description>
    <arm_group_label>Automatic inclusion and order set B</arm_group_label>
    <arm_group_label>Usual care and order set B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years old or greater admitted to the Hospital Medicine service at UCSF&#xD;
             Medical Center who meet criteria as determined by predictive model to be likely&#xD;
             admissions for COPD exacerbation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to other clinical services at UCSF Medical Center.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ari Hoffman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 15, 2019</last_update_submitted>
  <last_update_submitted_qc>June 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Ari Hoffman</investigator_full_name>
    <investigator_title>Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Informatics</keyword>
  <keyword>COPD</keyword>
  <keyword>quality improvement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028805
org study id: 16-19504
nct id: NCT03028805
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Use of evidence-based COPD order set
time frame: one year
description: Proportion of admissions for COPD exacerbation that use the COPD order set
measure: Average length of stay
time frame: one year
measure: Number of inpatient encounters
time frame: one year
measure: 30-day readmission rates
time frame: one year
measure: Mortality
time frame: one year
measure: Intubations
time frame: one year
measure: Code blue events
time frame: one year
measure: ICU admissions
time frame: one year
measure: Outpatient utilization
time frame: one year
description: Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up
measure: Discharge Disposition
time frame: one year
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)
measure: Proportion of enrolled patients billed for COPD related ICD-10 codes for primary or secondary diagnosis.
time frame: one year
description: ICD-10 codes as described by PRIME program, California's Medicaid 1115 Waiver
measure: Total costs of care
time frame: one year
arm group label: Usual care and order set A
arm group type: No Intervention
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 group label: Usual care and order set B
arm group type: Active Comparator
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 group label: Automatic inclusion and order set A
arm group type: Active Comparator
description: COPD order set is automatically included in admission orders as a static list.
arm group label: Automatic inclusion and order set B
arm group type: Active Comparator
description: COPD order set is automatically included in admission orders as a dynamic and end user tested version.
intervention type: Other
intervention name: Automatic inclusion of COPD orders in admission orders
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.
arm group label: Automatic inclusion and order set A
arm group label: Automatic inclusion and order set B
intervention type: Other
intervention name: Dynamic, end-user order set design
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.
arm group label: Automatic inclusion and order set B
arm group label: Usual care and order set B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ari Hoffman, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Ari Hoffman
investigator title: Assistant Clinical Professor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive