Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-22 @ 5:08 PM
Study NCT ID:
NCT02530216
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Automated Evaluation of Gastrointestinal Symptoms (AEGIS) on Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-29', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of documented alarm symptoms', 'timeFrame': 'Completed and documented by the physician in the clinic note within 1 week of the initial clinic visit', 'description': 'Prevalence of documented alarm symptoms (blood in the stool, unintentional weight loss, hematochezia, hematemesis) in the clinic note as documented by physicians.'}], 'secondaryOutcomes': [{'measure': 'Prevalence of diagnosed organic disease', 'timeFrame': 'Organic disease (e.g., Celiac disease, inflammatory bowel disease, etc.) diagnosed within 6 months of the initial clinic visit'}, {'measure': 'Time to diagnosis of organic disease', 'timeFrame': 'Time to diagnosis of organic disease (e.g., Celiac disease, inflammatory bowel disease, etc.) within 6 months of the initial clinic visit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abdominal Pain', 'Deglutition Disorders', 'Fecal Incontinence', 'Nausea', 'Diarrhea', 'Constipation', 'Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'Healthcare delivery now mandates shorter visits with higher documentation requirements, undermining the patient-provider interaction. Electronic health records (EHRs) have the potential to improve outcomes and quality of care in this pressured environment, and are endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to support value-based healthcare. However, EHR systems were principally designed to support the transactional needs of administrators and billers, less so to nurture the relationship between patients and their providers. The purpose of this research is to identify ways to use EHRs to support clinical gastroenterologists and their patients while meeting the meaningful use requirements of the HITECH Act.\n\nTo improve clinic visit efficiency and meet criteria for meaningful use, investigators developed a patient-provider portal (P3) that systematically collects patient symptoms using a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from a library of over 300 symptom attributes measuring the timing, severity, frequency, location, quality, and character of their GI symptoms, along with relevant comorbidities, family history, and alarm features. The system then automatically "translates" the patient report into a full narrative HPI available for use by GI providers in an EHR.\n\nIn a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS versus physician-documented HPIs, investigators found that blinded physician reviewers perceived that AEGIS HPIs were of higher overall quality, better organized, and more succinct, comprehensible, complete and useful compared to HPIs written by physicians during usual care in academic GI clinics. In the current study, investigators aim to evaluate computer-generated HPIs prospectively on a wider scale in diverse academic and community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention that ties patient HPIs to an individualized "education prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to the gastrointestinal clinic for evaluation.\n* Able to read and write English.\n* Has basic computing skills.\n\nExclusion Criteria:\n\n* Having been seen and evaluated in the gastrointestinal clinic within the last 8 months.'}, 'identificationModule': {'nctId': 'NCT02530216', 'acronym': 'AEGIS', 'briefTitle': 'Evaluating the Impact of Automated Evaluation of Gastrointestinal Symptoms (AEGIS) on Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Automated Evaluation of Gastrointestinal Symptoms (AEGIS): A Pragmatic Clinical Trial Evaluating the Impact of AEGIS on Clinical Outcomes', 'orgStudyIdInfo': {'id': 'Pro00045243'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Individuals in this arm will undergo usual care with their physician.'}, {'type': 'EXPERIMENTAL', 'label': 'AEGIS (Automated Evaluation of Gastrointestinal Symptoms)', 'description': 'Individuals in the AEGIS arm will be invited to use AEGIS/My GI Health prior to their clinic visit. For those who complete AEGIS/My GI Health, their physician will have access to their AEGIS symptom report (includes a GI symptom heat map and GI history) and tailored education prescription.', 'interventionNames': ['Other: AEGIS (Automated Evaluation of Gastrointestinal Symptoms)']}], 'interventions': [{'name': 'AEGIS (Automated Evaluation of Gastrointestinal Symptoms)', 'type': 'OTHER', 'description': 'AEGIS (Automated Evaluation of Gastrointestinal Symptoms) guides patients through questionnaires to measure symptom attributes including the timing, severity, frequency, location, quality, and character of their gastrointestinal (GI) symptoms, along with relevant comorbidities, family history, and alarm features. This information is transformed into a history of present illness (HPI) written in language familiar to clinicians. AEGIS also supports both the clinician and patient with an individualized "education prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments. The prescription is created by the portal based on each patient\'s unique AEGIS "fingerprint."', 'armGroupLabels': ['AEGIS (Automated Evaluation of Gastrointestinal Symptoms)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician and Health Services Research Scientist', 'investigatorFullName': 'Christopher Almario', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}