Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-01 @ 5:53 AM
Study NCT ID:
NCT01060995
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2010-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SmartConsent: A Computerized Informed Consent for Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2010-01-29', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Informed Consent', 'Oral Health', 'Patient Decision-making'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'SUMMARY:\n\nThe purpose of this study is to learn how to better educate patients about oral health procedures and treatments through an improved informed consent process. We will gather information from patients and health care providers, and design and test a computerized consent system called SmartConsent.\n\nHYPOTHESIS:\n\n1. Subjects who use SmartConsent will have increased knowledge (cognitive achievement) about oral health disease and treatment than patients who view the standard consent\n2. Subjects who use SmartConsent will have less decisional conflict in their decision regarding an oral health procedure than those who view the standard consent form\n3. Subjects who use SmartConsent will have greater visit satisfactions scores than those who view the standard consent form', 'detailedDescription': "Communicating personalized information to patients about the risks, benefits and other critical information about dental disease and treatment is often difficult for providers. In this proposal we seek to develop a novel informed consent system that can accurately translate and communicate information to patients in a standardized and effective manner based on their diagnosis and prescribed treatment. We aim to integrate SmartConsent into the institutional electronic patient record (EPR). This research is translational as it seeks to determine how providers can better communicate information to patients so they can make appropriate decisions about dental treatments and options.\n\nThe advent of electronic health records allows an informed consent document to be automatically personalized based on a patient's demographic profile, literacy level, language preference, and prior medical history. A computerized consent also allows the presentation of information in a format beyond text such as through the use of multimedia. Further, in a computer-based consent, we can quickly test a patient's knowledge about a diagnosis and procedure to ensure that key information has been delivered. In this proposal we seek to discover if a computer-based informed consent is more effective in educating patients about common oral health disease and treatment (e.g., reason for extracting a tooth, causes of periodontal disease, risks associated with dental implants). We also seek to determine its feasibility in a real clinical practice by measuring time taken and impact on workflow compared to the traditional consent process."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Urgent Care Clinic at UT Dental Branch at Houston', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* English-speaking\n* Diagnosis of pulpal disease\n\nExclusion Criteria:\n\n* Treatment required referral outside of clinic'}, 'identificationModule': {'nctId': 'NCT01060995', 'acronym': 'SmartConsent', 'briefTitle': 'SmartConsent: A Computerized Informed Consent for Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'SmartConsent: A Computerized Informed Consent for Patients', 'orgStudyIdInfo': {'id': 'HSC-DB-07-0593'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SmartConsent', 'description': 'Subjects receiving SmartConsent informed consent'}, {'label': 'Standard consent', 'description': 'Subjects receiving standard consent'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John Valenza, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC-Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean and Professor', 'investigatorFullName': 'John Valenza', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}