Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-03-01 @ 3:17 AM
Study NCT ID:
NCT03865303
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2019-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Lab for Diagnostic Fidelity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25551}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of automated phenotypes', 'timeFrame': '1 year', 'description': 'Use data from the patient electronic medical record to identify the number of diagnostic error or delay to validate clinical environment automated phenotypes'}, {'measure': 'Adoption (Number of time the Control Tower used during the clinical encounters)', 'timeFrame': '1 year', 'description': 'Standardized process tracking sheets to track each time the control tower system is triggered and used.'}, {'measure': 'Implementation Acceptability', 'timeFrame': '1 year', 'description': 'Focused questions about beliefs, attitudes, usability by healthcare providers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Illness', 'Patient Safety', 'Delivery of Health Care', 'Electronic Health Records'], 'conditions': ['Critical Illness']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Diagnostic error and delay remain a leading cause of preventable harm and death in the United States. Using a learning laboratory structure, researchers will implement mixed-methods research approaches to identify the systemic weaknesses that contribute to diagnostic error and delay in the hospital setting. The knowledge gained from research innovative will allow researchers to design, develop, implement, and refined a suite of human-centered tools that can be deployed to reduce the risk of diagnostic error and delay in both community and academic hospital settings.', 'detailedDescription': 'Despite the recognition that diagnostic errors an delays are a major contributor to preventable deaths in the USA, little progress has been made to reduce mortality outcomes from this known killer. An effective strategy leading to meaningful reduction in diagnostic error and delay rates has not made its way into practice. This proposal is unique and novel and combines mixed-methods research approaches with systems engineering research approaches to understand the interplay of the multiple factors contributing to diagnostic error and delay. The knowledge gained from this holistic approach will then be used within the learning laboratory to inform the design, development, evaluation, and refinement of the solutions to diagnostic error and delay. "Control Tower" will be the staging ground for the in situ learning laboratory and will be built on top of a well-established clinical informatics infrastructure and hospital environment open to innovation and practice change.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. All patients at risk of diagnostic error will be eligible for the study.\n2. We will include both sexes and all genders and all minority populations as they present with the risk of diagnostic error in the hospitals.\n\nGiven the nature of the study, which focuses on patients with or at risk of diagnostic error, outreach efforts to underrepresented populations or individuals would not be possible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* For EMR review all adults admitted to the hospital ages 18 and older with research authorization\n* For survey-clinicians including physicians, advanced care practitioners\n* For focus groups and interviews-clinicians including physicians, advanced care practitioners\n\nExclusion Criteria\n\n* Age \\<18 years old\n* No research authorization\n* Refusal to give consent'}, 'identificationModule': {'nctId': 'NCT03865303', 'briefTitle': 'Learning Lab for Diagnostic Fidelity', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Acute Care Learning Laboratory-Reducing Threats to Diagnostic Fidelity in Critical Illness', 'orgStudyIdInfo': {'id': '18-007115'}, 'secondaryIdInfos': [{'id': 'R18HS026609', 'link': 'https://reporter.nih.gov/quickSearch/R18HS026609', 'type': 'AHRQ'}]}, 'contactsLocationsModule': {'locations': [{'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System - Mankato MCHS', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Brian W Pickering, M.B., B.Ch.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pricinple Investigator', 'investigatorFullName': 'Brian W. Pickering, M.B., B.Ch.', 'investigatorAffiliation': 'Mayo Clinic'}}}}