SmartConsent: A Computerized Informed Consent for Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition |
|---|
|
Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | SmartConsent: A Computerized Informed Consent for Patients |
| Enrollment: | 50 |
| Study Start Date: | January 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
SmartConsent
Subjects receiving SmartConsent informed consent
|
|
Standard consent
Subjects receiving standard consent
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Urgent Care Clinic at UT Dental Branch at Houston
Inclusion Criteria:
- Adult
- English-speaking
- Diagnosis of pulpal disease
Exclusion Criteria:
- Treatment required referral outside of clinic
Contacts and Locations
More Information
No publications provided
| Responsible Party: | John A. Valenza, D.D.S., The University of Texas Dental Branch at Houston |
| ClinicalTrials.gov Identifier: | NCT01060995 History of Changes |
| Other Study ID Numbers: | HSC-DB-07-0593 |
| Study First Received: | January 29, 2010 |
| Last Updated: | February 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Informed Consent Oral Health Patient Decision-making |
ClinicalTrials.gov processed this record on May 23, 2013