Informed ConsentNCT00899392
Improving Informed Consent in Pediatric Endoscopy
A study testing Emmi Pediatric Upper Endoscopy Patient Education Module in people with Informed Consent and Procedural State Anxiety, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent, Procedural State Anxiety, Subject's Satisfaction
- What is being tested?
- Emmi Pediatric Upper Endoscopy Patient Education Module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Parent of child undergoing 1st, elective, outpatient, sedated, upper endoscopy (EGD)
- Subject gives consent to participate
- Child of parent does not have a planned endoscopy intervention.
Who cannot join
- Does not speak or understand English
- Does not give consent to participate
- Does not complete consent instrument at a minimum during study
Trial locations and contacts
1 site in 1 country.
United States1 site
Chidren's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Improving Informed Consent and Assent in Pediatric Endoscopy
Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state of parental and adolescent consent/assent in upper gastrointestinal endoscopy and offering a computer based education program to improve it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of informed consent, and patient flow efficiency in a GI endoscopy suite.
Read the detailed description
Two hundred first-time upper endoscopy patients from The Children's Hospital of Philadelphia will be prospectively selected for participation in the study. One hundred subjects will then be randomized to participate in either the standard consent arm or the electronic assisted informed consent (EAIC) arm. The electronic assisted informed consent web module is a professionally designed program by Emmi Solutions, LLC. Adolescents, if present and greater than 13 years of age, will undergo the program apart from their parent as a separate subgroup not included in the 100 randomized subjects. At time of endoscopy scheduling, the scheduler will ask the subjects if they would like to participate in the study. If interest is expressed the study coordinator or PI will contact the subject to explain the study and inform them of the study parameters. At time of phone contact, consent or assent via a verbal method will be performed. Once verbal consent is given by the subject or verbal assent by the adolescent subject they will follow the protocol. No incentives will be given to the subjects. Institutional Review Board (IRB) approval will be obtained.
Between 24 and 48 hours prior to endoscopy, the participant will have the option to access the web-based module outside the hospital or through a hospital-based kiosk. The web address used is http://www.pedsgiconsent.com. Just prior to starting the module, a five-minute electronic pre-intervention test will be given and its results recorded in an electronic database. This will gather demographic and pre-intervention state anxiety without personal identifying information. After the survey is complete, the educational module will be accessed. Upon completion, the subjects will print a confirmatory document of completion and a list of questions to hand to their physician at time of endoscopy. Hand written questions will also be permitted. Non-EAIC participants will perform a non-educational web program not related to gastroenterology and also have their endoscopy questions printed to give to their physician. The questions and confirmation sheet will also be presented to their physician at time of procedure. Participants will also have space to write further questions by hand on the form. The questions collected will be used to assess number and complexity of questions asked as influenced by the education program. The web module will record time duration taken for the program. After completing the program, the participants will report to the GI suite as previously scheduled. The procedure will occur without either the practitioner or nursing staff knowing in which arm of the study the participants are enrolled. After the questions are answered and formal GI endoscopy procedural consent is obtained, the question sheet will be deposited in a lock box in the endoscopy suite for review at a later time. Total time spent in the endoscopy suite will be recorded. Prior to the patient's endoscopy, but after formal consent is obtained, the participant will then take a ten minute electronic post-test to ascertain satisfaction (mGHAA-modified-Group Health Association of America Survey-9), change in state anxiety [s-STAI-(Spielberger-State Trait Anxiety Inventory (state section)], and change in understanding of consent parameters achieved. Satisfaction will be measured using the validated modified Group Health Association of America-9 Survey (mGHAA-9). It is a well-validated instrument used to measure patient satisfaction in adult endoscopy. Probing questions to evaluate the attainment of consent will be based on a modified survey taken from Woodrow's study titled, "How Thorough is the Process of Informed Consent Prior to Outpatient Gastroscopy?"(Consent-20)
- Being tested
- Emmi Pediatric Upper Endoscopy Patient Education Module
- Keywords
- consent, Anxiety, Satisfaction, Efficiency, Questions, Attainment of Informed Consent (Consent-20), Procedural State Anxiety (STAI), Subject Satisfaction (mGHAA-9), Duration in Endoscopy Suite, Number of questions asked
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emmi Pediatric Upper Endoscopy Patient Education ModuleOther
Also called Pediatric Upper Endoscopy Patient Education Module, Patient Education Module, Upper Endoscopy Patient Education Module, Endoscopy Patient Education Module
Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC
| Study group | Role | What they receive |
|---|---|---|
| Electronic Assisted Consent | Experimental | Standard procedural consent performed by pediatric gastroenterologist plus assistance from computerized emmi module. Receives: Other: Emmi Pediatric Upper Endoscopy Patient Education Module |
| Control Consent | No intervention | Standard procedural consent as performed by pediatric gastroenterologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)
Units on a scale (score) as Measured by Consent 20 Instrument.
20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.
Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40
Measured: Every 1-2 months
Secondary outcomes (4)
Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)
Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.
Measured: Every 1-2 months
Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)
s-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.
Measured: 12-18 hours (Night before Endoscopy to Day of Endoscopy)
Questions Asked by Subjects (Parents)
Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.
Measured: Questions written by parents during the end of consent process (48-72 hours)
GI Suite Flow Efficiency Measured in 15 Minute Increments
Measured: At completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Midwestern University
- Responsible party
- Sponsor
- Investigators
- Petar Mamula, M.D., Principal investigator, Children's Hospital of PhiladelphiaJoel Friedlander, D.O., M.Be., Principal investigator, Children's Hospital of PhildelphiaGreg Loeben, Ph.D., Study chair, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899392
- Sponsor's protocol ID
- 2008-6-6053
- Status last verified
- Jul 2013
- First submitted
- 8 May 2009
- Last updated
- 30 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Woodrow SR, Jenkins AP. How thorough is the process of informed consent prior to outpatient gastroscopy? A study of practice in a United Kingdom District Hospital. Digestion. 2006;73(2-3):189-97. doi: 10.1159/000094528. Epub 2006 Jul 11.
PubMed 16837805Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.
PubMed 18085930Yacavone RF, Locke GR 3rd, Gostout CJ, Rockwood TH, Thieling S, Zinsmeister AR. Factors influencing patient satisfaction with GI endoscopy. Gastrointest Endosc. 2001 Jun;53(7):703-10. doi: 10.1067/mge.2001.115337.
PubMed 11375575Standards of Practice Committee; Zuckerman MJ, Shen B, Harrison ME 3rd, Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA, Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy. Gastrointest Endosc. 2007 Aug;66(2):213-8. doi: 10.1016/j.gie.2007.02.029. No abstract available.
PubMed 17643691Friedlander JA, Loeben GS, Finnegan PK, Puma AE, Zhang X, de Zoeten EF, Piccoli DA, Mamula P. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy. J Med Ethics. 2011 Apr;37(4):194-200. doi: 10.1136/jme.2010.037622. Epub 2011 Jan 18.
PubMed 21245476
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Informed Consent and Assent in Pediatric Endoscopy
- ClinicalTrials.gov ID
- NCT00899392
- Acronym / sponsor ID
- 2008-6-6053
- Keywords
- consent, Anxiety, Satisfaction, Efficiency, Questions, Attainment of Informed Consent (Consent-20), Procedural State Anxiety (STAI), Subject Satisfaction (mGHAA-9)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Midwestern University
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 30 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state of parental and adolescent consent/assent in upper gastrointestinal endoscopy and offering a computer based education program to improve it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of informed consent, and patient flow efficiency in a GI endoscopy suite.
Detailed description
Two hundred first-time upper endoscopy patients from The Children's Hospital of Philadelphia will be prospectively selected for participation in the study. One hundred subjects will then be randomized to participate in either the standard consent arm or the electronic assisted informed consent (EAIC) arm. The electronic assisted informed consent web module is a professionally designed program by Emmi Solutions, LLC. Adolescents, if present and greater than 13 years of age, will undergo the program apart from their parent as a separate subgroup not included in the 100 randomized subjects. At time of endoscopy scheduling, the scheduler will ask the subjects if they would like to participate in the study. If interest is expressed the study coordinator or PI will contact the subject to explain the study and inform them of the study parameters. At time of phone contact, consent or assent via a verbal method will be performed. Once verbal consent is given by the subject or verbal assent by the adolescent subject they will follow the protocol. No incentives will be given to the subjects. Institutional Review Board (IRB) approval will be obtained.
Between 24 and 48 hours prior to endoscopy, the participant will have the option to access the web-based module outside the hospital or through a hospital-based kiosk. The web address used is http://www.pedsgiconsent.com. Just prior to starting the module, a five-minute electronic pre-intervention test will be given and its results recorded in an electronic database. This will gather demographic and pre-intervention state anxiety without personal identifying information. After the survey is complete, the educational module will be accessed. Upon completion, the subjects will print a confirmatory document of completion and a list of questions to hand to their physician at time of endoscopy. Hand written questions will also be permitted. Non-EAIC participants will perform a non-educational web program not related to gastroenterology and also have their endoscopy questions printed to give to their physician. The questions and confirmation sheet will also be presented to their physician at time of procedure. Participants will also have space to write further questions by hand on the form. The questions collected will be used to assess number and complexity of questions asked as influenced by the education program. The web module will record time duration taken for the program. After completing the program, the participants will report to the GI suite as previously scheduled. The procedure will occur without either the practitioner or nursing staff knowing in which arm of the study the participants are enrolled. After the questions are answered and formal GI endoscopy procedural consent is obtained, the question sheet will be deposited in a lock box in the endoscopy suite for review at a later time. Total time spent in the endoscopy suite will be recorded. Prior to the patient's endoscopy, but after formal consent is obtained, the participant will then take a ten minute electronic post-test to ascertain satisfaction (mGHAA-modified-Group Health Association of America Survey-9), change in state anxiety [s-STAI-(Spielberger-State Trait Anxiety Inventory (state section)], and change in understanding of consent parameters achieved. Satisfaction will be measured using the validated modified Group Health Association of America-9 Survey (mGHAA-9). It is a well-validated instrument used to measure patient satisfaction in adult endoscopy. Probing questions to evaluate the attainment of consent will be based on a modified survey taken from Woodrow's study titled, "How Thorough is the Process of Informed Consent Prior to Outpatient Gastroscopy?"(Consent-20)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Assisted Consent | Experimental | Other: Emmi Pediatric Upper Endoscopy Patient Education ModuleStandard procedural consent performed by pediatric gastroenterologist plus assistance from computerized emmi module. |
| Control Consent | No intervention | –Standard procedural consent as performed by pediatric gastroenterologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent of child undergoing 1st, elective, outpatient, sedated, upper endoscopy (EGD)
- Subject gives consent to participate
- Child of parent does not have a planned endoscopy intervention.
Key exclusion criteria (3 listed)
- Does not speak or understand English
- Does not give consent to participate
- Does not complete consent instrument at a minimum during study
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 |
|---|---|---|
| Emmi Pediatric Upper Endoscopy Patient Education ModuleAlso: Pediatric Upper Endoscopy Patient Education Module, Patient Education Module, Upper Endoscopy Patient Education Module, Endoscopy Patient Education ModuleEmmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC | Other | Electronic Assisted Consent |
Primary outcome
Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)
Time frame: Every 1-2 months
Units on a scale (score) as Measured by Consent 20 Instrument. 20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points. Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40
4 secondary outcomes
Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)
Time frame: Every 1-2 months
Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)
Time frame: 12-18 hours (Night before Endoscopy to Day of Endoscopy)
Questions Asked by Subjects (Parents)
Time frame: Questions written by parents during the end of consent process (48-72 hours)
GI Suite Flow Efficiency Measured in 15 Minute Increments
Time frame: At completion of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16837805Woodrow SR, Jenkins AP. How thorough is the process of informed consent prior to outpatient gastroscopy? A study of practice in a United Kingdom District Hospital. Digestion. 2006;73(2-3):189-97. doi: 10.1159/000094528. Epub 2006 Jul 11.
- Background: PubMed 18085930Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.
- Background: PubMed 11375575Yacavone RF, Locke GR 3rd, Gostout CJ, Rockwood TH, Thieling S, Zinsmeister AR. Factors influencing patient satisfaction with GI endoscopy. Gastrointest Endosc. 2001 Jun;53(7):703-10. doi: 10.1067/mge.2001.115337.
- Background: PubMed 17643691Standards of Practice Committee; Zuckerman MJ, Shen B, Harrison ME 3rd, Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA, Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy. Gastrointest Endosc. 2007 Aug;66(2):213-8. doi: 10.1016/j.gie.2007.02.029. No abstract available.
- Derived from this study: PubMed 21245476Friedlander JA, Loeben GS, Finnegan PK, Puma AE, Zhang X, de Zoeten EF, Piccoli DA, Mamula P. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy. J Med Ethics. 2011 Apr;37(4):194-200. doi: 10.1136/jme.2010.037622. Epub 2011 Jan 18.
- The Study Web SiteLink provided by the sponsor.
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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.
Petar Mamula, M.D. principal investigator
Children's Hospital of Philadelphia
Joel Friedlander, D.O., M.Be. principal investigator
Children's Hospital of Phildelphia
Greg Loeben, Ph.D. study chair
Midwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emmi Pediatric Upper Endoscopy Patient Education Module in people with Informed Consent and Procedural State Anxiety, run by Children's Hospital of Philadelphia 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 3 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 30 Jul 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?
Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Attainment of Informed Consent as Measured by Consent Instrument (Consent-20) (time frame: Every 1-2 months). 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 NCT00899392, which also lists 5 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 30 Jul 2013.