SmartConsent: A Computerized Informed Consent for Patients (SmartConsent)

Tracking Information
First Submitted Date	January 29, 2010
First Posted Date	February 2, 2010
Last Update Posted Date	May 4, 2018
Study Start Date	January 2009
Actual Primary Completion Date	July 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01060995 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	SmartConsent: A Computerized Informed Consent for Patients
Official Title	SmartConsent: A Computerized Informed Consent for Patients
Brief Summary	SUMMARY: The 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. HYPOTHESIS: Subjects who use SmartConsent will have increased knowledge (cognitive achievement) about oral health disease and treatment than patients who view the standard consent; 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; Subjects who use SmartConsent will have greater visit satisfactions scores than those who view the standard consent form
Detailed Description	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. The 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.
Study Type	Observational
Study Design	Observational Model: Case-Control; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Urgent Care Clinic at UT Dental Branch at Houston
Condition	Healthy
Intervention	Not Provided
Study Groups/Cohorts	SmartConsent Subjects receiving SmartConsent informed consent; Standard consent Subjects receiving standard consent
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: February 1, 2010)	50
Original Actual Enrollment	Same as current
Actual Study Completion Date	March 26, 2013
Actual Primary Completion Date	July 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Adult; English-speaking; Diagnosis of pulpal disease Exclusion Criteria: Treatment required referral outside of clinic
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT01060995
Other Study ID Numbers	HSC-DB-07-0593
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	John Valenza, The University of Texas Health Science Center, Houston
Study Sponsor	The University of Texas Health Science Center, Houston
Collaborators	The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Investigators	Principal Investigator: John Valenza, DDS UTHSC-Houston
PRS Account	The University of Texas Health Science Center, Houston
Verification Date	May 2018