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SmartConsent: A Computerized Informed Consent for Patients (SmartConsent)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060995
First Posted: February 2, 2010
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
Information provided by:
The University of Texas Health Science Center, Houston
  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:

  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

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: SmartConsent: A Computerized Informed Consent for Patients

Further study details as provided by The University of Texas Health Science Center, Houston:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Urgent Care Clinic at UT Dental Branch at Houston
Criteria

Inclusion Criteria:

  • Adult
  • English-speaking
  • Diagnosis of pulpal disease

Exclusion Criteria:

  • Treatment required referral outside of clinic
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060995


Sponsors and Collaborators
The University of Texas Health Science Center, Houston
CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCES
Investigators
Principal Investigator: John Valenza, DDS UTHSC-Houston
  More Information

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
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2010

Keywords provided by The University of Texas Health Science Center, Houston:
Informed Consent
Oral Health
Patient Decision-making