HealthySmartConsentNCT01060995
SmartConsent: A Computerized Informed Consent for Patients
An observational study of Healthy, run by The University of Texas Health Science Center, Houston.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to 26 Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urgent Care Clinic at UT Dental Branch at Houston
Who may be able to join
- Adult
- English-speaking
- Diagnosis of pulpal disease
Who cannot join
- Treatment required referral outside of clinic
About this study
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.
Read more
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
Read the 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.
- Conditions
- Healthy
- Keywords
- Informed Consent, Oral Health, Patient Decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SmartConsent | Subjects receiving SmartConsent informed consent | |
| Standard consent | Subjects receiving standard consent |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completion26 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
- Responsible party
- Principal investigator, John Valenza, The University of Texas Health Science Center, Houston
- Investigators
- John Valenza, DDS, Principal investigator, UTHSC-Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060995
- Sponsor's protocol ID
- HSC-DB-07-0593
- Acronym
- SmartConsent
- Status last verified
- May 2018
- First submitted
- 29 Jan 2010
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartConsent: A Computerized Informed Consent for Patients
- ClinicalTrials.gov ID
- NCT01060995
- Acronym / sponsor ID
- SmartConsent / HSC-DB-07-0593
- Conditions
- Healthy
- Keywords
- Informed Consent, Oral Health, Patient Decision-making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- 26 Mar 2013 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartConsent | – | –Subjects receiving SmartConsent informed consent |
| Standard consent | – | –Subjects receiving standard consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urgent Care Clinic at UT Dental Branch at Houston
Key inclusion criteria (3 listed)
- Adult
- English-speaking
- Diagnosis of pulpal disease
Key exclusion criteria (1 listed)
- Treatment required referral outside of clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Valenza, DDS principal investigator
UTHSC-Houston
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.