Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

SmartConsent: A Computerized Informed Consent for Patients

This study has been completed.
Sponsor:
Collaborator:
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01060995
First received: January 29, 2010
Last updated: February 1, 2010
Last verified: January 2010

January 29, 2010
February 1, 2010
January 2009
July 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01060995 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SmartConsent: A Computerized Informed Consent for Patients
SmartConsent: A Computerized Informed Consent for Patients

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:

  1. Subjects who use SmartConsent will have increased knowledge (cognitive achievement) about oral health disease and treatment than patients who view the standard consent
  2. 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
  3. Subjects who use SmartConsent will have greater visit satisfactions scores than those who view the standard consent form

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Urgent Care Clinic at UT Dental Branch at Houston

Healthy
Not Provided
  • SmartConsent
    Subjects receiving SmartConsent informed consent
  • Standard consent
    Subjects receiving standard consent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult
  • English-speaking
  • Diagnosis of pulpal disease

Exclusion Criteria:

  • Treatment required referral outside of clinic
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01060995
HSC-DB-07-0593
Yes
John A. Valenza, D.D.S., The University of Texas Dental Branch at Houston
The University of Texas Health Science Center, Houston
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
Principal Investigator: John Valenza, DDS UTHSC-Houston
The University of Texas Health Science Center, Houston
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP