SmartConsent: A Computerized Informed Consent for Patients (SmartConsent)
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ClinicalTrials.gov Identifier: NCT01060995 |
Recruitment Status
:
Completed
First Posted
: February 2, 2010
Last Update Posted
: February 2, 2010
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Tracking Information | ||||
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First Submitted Date | January 29, 2010 | |||
First Posted Date | February 2, 2010 | |||
Last Update Posted Date | February 2, 2010 | |||
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 | No Changes Posted | |||
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:
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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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Cross-Sectional |
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
50 | |||
Original Actual Enrollment | Same as current | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
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 A. Valenza, D.D.S., The University of Texas Dental Branch at Houston | |||
Study Sponsor | The University of Texas Health Science Center, Houston | |||
Collaborators | CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES | |||
Investigators |
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PRS Account | The University of Texas Health Science Center, Houston | |||
Verification Date | January 2010 |