Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-12 @ 12:43 AM
Study NCT ID:
NCT03028805
Status:
TERMINATED
Last Update Posted:
2019-06-18
First Post:
2017-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'whyStopped': 'Trend toward increased readmissions in the auto-delivery arm.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-15', 'studyFirstSubmitDate': '2017-01-04', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of evidence-based COPD order set', 'timeFrame': 'one year', 'description': 'Proportion of admissions for COPD exacerbation that use the COPD order set'}], 'secondaryOutcomes': [{'measure': 'Average length of stay', 'timeFrame': 'one year'}, {'measure': 'Number of inpatient encounters', 'timeFrame': 'one year'}, {'measure': '30-day readmission rates', 'timeFrame': 'one year'}, {'measure': 'Mortality', 'timeFrame': 'one year'}, {'measure': 'Intubations', 'timeFrame': 'one year'}, {'measure': 'Code blue events', 'timeFrame': 'one year'}, {'measure': 'ICU admissions', 'timeFrame': 'one year'}, {'measure': 'Outpatient utilization', 'timeFrame': 'one year', 'description': 'Encounters for primary care clinic, Pulmonary clinic, Emergency Department or observation during 12 month follow-up'}, {'measure': 'Discharge Disposition', 'timeFrame': '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.', 'timeFrame': 'one year', 'description': "ICD-10 codes as described by PRIME program, California's Medicaid 1115 Waiver"}, {'measure': 'Total costs of care', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Informatics', 'COPD', 'quality improvement'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Pulmonary Diseases, Obstructive']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nFirst, 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.\n\nSecond, 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Patients admitted to other clinical services at UCSF Medical Center.'}, 'identificationModule': {'nctId': 'NCT03028805', 'acronym': 'EPICPath', 'briefTitle': 'Study of Automated Care Pathway for Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '16-19504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care and order set A', '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.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care and order set B', '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.', 'interventionNames': ['Other: Dynamic, end-user order set design']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automatic inclusion and order set A', 'description': 'COPD order set is automatically included in admission orders as a static list.', 'interventionNames': ['Other: Automatic inclusion of COPD orders in admission orders']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Automatic inclusion and order set B', 'description': 'COPD order set is automatically included in admission orders as a dynamic and end user tested version.', 'interventionNames': ['Other: Automatic inclusion of COPD orders in admission orders', 'Other: Dynamic, end-user order set design']}], 'interventions': [{'name': 'Automatic inclusion of COPD orders in admission orders', 'type': 'OTHER', '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.', 'armGroupLabels': ['Automatic inclusion and order set A', 'Automatic inclusion and order set B']}, {'name': 'Dynamic, end-user order set design', 'type': 'OTHER', '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.', 'armGroupLabels': ['Automatic inclusion and order set B', 'Usual care and order set B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ari Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Ari Hoffman', 'investigatorAffiliation': 'University of California, San Francisco'}}}}