Improving Informed Consent ProcessNCT01955070
Use of a Multimedia Presentation for Informed Consent
A study testing Multimedia Presentation for Ketamine sedation in people with Improving Informed Consent Process, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. The goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Improving Informed Consent Process
- What is being tested?
- Multimedia Presentation for Ketamine sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Receiving ketamine sedation for fracture reduction
- Less than 18 years of age
- English as primary language
Who cannot join
- patients who received medications in addition to ketamine for sedation
- Families where English was not the primary language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department
This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. The goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process.
Read the detailed description
BACKGROUND: Informed consent (IC) is an ethical process for ensuring patient autonomy. Multimedia presentations (MMP) often aid the IC process for research studies. Thus, it follows that MMP would improve IC in clinical settings.
OBJECTIVE: To determine if MMP for the IC process for ketamine sedation improves parental satisfaction and comprehension as compared to standard practice.
DESIGN/METHODS: This two phase study compared two methods of IC for ketamine sedation of pediatric patients. Phase one was a randomized, prospective study that compared the standard verbal consent to a MMP. Phase two implemented the MMP into daily work flow. Parents completed a survey evaluating their satisfaction of the IC process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the IC process and knowledge of ketamine sedation.
- Conditions
- Improving Informed Consent Process
- Being tested
- Multimedia Presentation for Ketamine sedation
- Keywords
- Informed consent, Ethics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia Presentation for Ketamine sedationOther
PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
| Study group | Role | What they receive |
|---|---|---|
| Implementation | Experimental | Multimedia Presentation for Ketamine sedation Receives: Other: Multimedia Presentation for Ketamine sedation |
| Intervention | Experimental | Multimedia Presentation for Ketamine sedation Receives: Other: Multimedia Presentation for Ketamine sedation |
| Control | No intervention | Patients that received the standard consent with signed consent form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' satisfaction with the informed consent process
Parents are given a survey with a 5-point Likert scale to evaluated their satisfaction with the informed consent process
Measured: Within 1 hour of consent
The parent's knowledge of ketamine sedation.
The parents are give a multiple choice quiz on the information present on ketamine sedation
Measured: Within one hour of consent
Secondary outcomes (3)
Satisfaction within each domain
The satisfaction questions on the survey are divided into groups addressing the four key elements of informed consent: beneficence, maleficence, content, and assent.
Measured: Within one hour of consent
Comparison of satisfaction and knowledge with demographics
The survey and quiz results are compared depending on demographics
Measured: Within one hour of consent
Provider Satisfaction
Provider satisfaction was collected using a Likert scale at the time the presentation was embedded into the computer order entry system. They were re-surveyed 6 months later to see if there was any change in the satisfaction results
Measured: Time 0 and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Improving Informed Consent ProcessStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Spencer, Nationwide Children's Hospital
- Investigators
- Sandra P Spencer, MD, Principal investigator, Nationwide Childrens, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955070
- Sponsor's protocol ID
- MMP for Informed Consent
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Informed consent for elective and emergency surgery: questionnaire study. BJOG. 2004 Oct;111(10):1133-8. doi: 10.1111/j.1471-0528.2004.00240.x.
PubMed 15383117Baren J, Campbell CF, Schears RM, Shofer FS, Datner EM, Hollander JE. Observed behaviors of subjects during informed consent for an emergency department study. Ann Emerg Med. 2010 Jan;55(1):9-14. doi: 10.1016/j.annemergmed.2009.09.023. Epub 2009 Nov 22.
PubMed 19931940Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003 Nov-Dec;25(6):1-7. No abstract available.
PubMed 15035248Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-601. doi: 10.1001/jama.292.13.1593.
PubMed 15467062Nwomeh BC, Hayes J, Caniano DA, Upperman JS, Kelleher KJ. A parental educational intervention to facilitate informed consent for emergency operations in children. J Surg Res. 2009 Apr;152(2):258-63. doi: 10.1016/j.jss.2008.01.008. Epub 2008 Feb 4.
PubMed 18374948Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department. Pediatr Emerg Care. 2015 Aug;31(8):572-6. doi: 10.1097/PEC.0000000000000513.
PubMed 26221786
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Multimedia Presentation to Enhance the Informed Consent for Ketamine Sedation in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT01955070
- Acronym / sponsor ID
- MMP for Informed Consent
- Conditions
- Improving Informed Consent Process
- Keywords
- Informed consent, Ethics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Oct 2013 (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.
This is a prospective cohort study in which the standard verbal informed consent process for ketamine sedation is compared to a multimedia informed consent process. The goals include determining if parents prefer a multimedia consent process and evaluating the effectiveness of multimedia consent process.
Detailed description
BACKGROUND: Informed consent (IC) is an ethical process for ensuring patient autonomy. Multimedia presentations (MMP) often aid the IC process for research studies. Thus, it follows that MMP would improve IC in clinical settings.
OBJECTIVE: To determine if MMP for the IC process for ketamine sedation improves parental satisfaction and comprehension as compared to standard practice.
DESIGN/METHODS: This two phase study compared two methods of IC for ketamine sedation of pediatric patients. Phase one was a randomized, prospective study that compared the standard verbal consent to a MMP. Phase two implemented the MMP into daily work flow. Parents completed a survey evaluating their satisfaction of the IC process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the IC process and knowledge of ketamine sedation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implementation | Experimental | Other: Multimedia Presentation for Ketamine sedationMultimedia Presentation for Ketamine sedation |
| Intervention | Experimental | Other: Multimedia Presentation for Ketamine sedationMultimedia Presentation for Ketamine sedation |
| Control | No intervention | –Patients that received the standard consent with signed consent form |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Receiving ketamine sedation for fracture reduction
- Less than 18 years of age
- English as primary language
Key exclusion criteria (2 listed)
- patients who received medications in addition to ketamine for sedation
- Families where English was not the primary language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia Presentation for Ketamine sedationPowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation | Other | Implementation, Intervention |
Primary outcome
Parents' satisfaction with the informed consent process
Time frame: Within 1 hour of consent
Parents are given a survey with a 5-point Likert scale to evaluated their satisfaction with the informed consent process
The parent's knowledge of ketamine sedation.
Time frame: Within one hour of consent
The parents are give a multiple choice quiz on the information present on ketamine sedation
3 secondary outcomes
Satisfaction within each domain
Time frame: Within one hour of consent
Comparison of satisfaction and knowledge with demographics
Time frame: Within one hour of consent
Provider Satisfaction
Time frame: Time 0 and 6 months later
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 7 Oct 2013.
- Background: PubMed 15383117Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Informed consent for elective and emergency surgery: questionnaire study. BJOG. 2004 Oct;111(10):1133-8. doi: 10.1111/j.1471-0528.2004.00240.x.
- Background: PubMed 19931940Baren J, Campbell CF, Schears RM, Shofer FS, Datner EM, Hollander JE. Observed behaviors of subjects during informed consent for an emergency department study. Ann Emerg Med. 2010 Jan;55(1):9-14. doi: 10.1016/j.annemergmed.2009.09.023. Epub 2009 Nov 22.
- Background: PubMed 15035248Agre P, Rapkin B. Improving informed consent: a comparison of four consent tools. IRB. 2003 Nov-Dec;25(6):1-7. No abstract available.
- Background: PubMed 15467062Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-601. doi: 10.1001/jama.292.13.1593.
- Background: PubMed 18374948Nwomeh BC, Hayes J, Caniano DA, Upperman JS, Kelleher KJ. A parental educational intervention to facilitate informed consent for emergency operations in children. J Surg Res. 2009 Apr;152(2):258-63. doi: 10.1016/j.jss.2008.01.008. Epub 2008 Feb 4.
- Derived from this study: PubMed 26221786Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department. Pediatr Emerg Care. 2015 Aug;31(8):572-6. doi: 10.1097/PEC.0000000000000513.
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.
Sandra P Spencer, MD principal investigator
Nationwide Childrens, Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia Presentation for Ketamine sedation in people with Improving Informed Consent Process, run by Nationwide Children's Hospital at 1 site in United States.
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 2 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 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Parents' satisfaction with the informed consent process (time frame: Within 1 hour of consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955070, which also lists 6 linked publications.
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 7 Oct 2013.