Trial Outcomes & Findings for Improving Informed Consent in Pediatric Endoscopy (NCT NCT00899392)
NCT ID: NCT00899392
Last Updated: 2013-07-30
Results Overview
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
COMPLETED
NA
148 participants
Every 1-2 months
2013-07-30
Participant Flow
Between October 2008 and March 2009, parents of 220 children scheduled for clinically indicated upper endoscopy were prospectively and consecutively contacted. 190 subjects verbally consented to be in the study and 148 subsequently participated. 6 were withdrawn from data secondary to entering disqualifying demographic response (not in data set)
30 subjects did not participate because they did not consent to participate. These were not enrolled in the study.
Participant milestones
| Measure |
Electronic Assisted Consent (EAC)
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
Form-based informed consent as performed by pediatric gastroenterologists
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
74
|
|
Overall Study
COMPLETED
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
21
|
24
|
Reasons for withdrawal
| Measure |
Electronic Assisted Consent (EAC)
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
Form-based informed consent as performed by pediatric gastroenterologists
|
|---|---|---|
|
Overall Study
Subject didn't finish/partial pilot data
|
21
|
24
|
Baseline Characteristics
Improving Informed Consent in Pediatric Endoscopy
Baseline characteristics by cohort
| Measure |
Electronic Assisted Consent (EAC)
n=68 Participants
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
n=74 Participants
Form-based informed consent as performed by pediatric gastroenterologists
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 1-2 monthsUnits 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
Outcome measures
| Measure |
Electronic Assisted Consent (EAC)
n=47 Participants
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
n=50 Participants
Form-based informed consent as performed by pediatric gastroenterologists
|
|---|---|---|
|
Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)
|
37.36 Units on a scale
Standard Deviation 2.7
|
33.2 Units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Every 1-2 monthsPopulation: (Consent Group + some pilot participants to increase power of analysis)
Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.
Outcome measures
| Measure |
Electronic Assisted Consent (EAC)
n=63 Participants
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
n=67 Participants
Form-based informed consent as performed by pediatric gastroenterologists
|
|---|---|---|
|
Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)
|
41.79 Units on a scale
Standard Deviation 3.6
|
41.46 Units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: 12-18 hours (Night before Endoscopy to Day of Endoscopy)Population: Matched pairs (pre consent and post consent), Pilot data included to increase power analysis
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.
Outcome measures
| Measure |
Electronic Assisted Consent (EAC)
n=60 Participants
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
n=63 Participants
Form-based informed consent as performed by pediatric gastroenterologists
|
|---|---|---|
|
Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)
Day Before Procedure
|
42.17 Units on a Scale (STAI Score)
Standard Deviation 14.32
|
37.17 Units on a Scale (STAI Score)
Standard Deviation 12.56
|
|
Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)
Moments after consent
|
38.77 Units on a Scale (STAI Score)
Standard Deviation 12.79
|
33.76 Units on a Scale (STAI Score)
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Questions written by parents during the end of consent process (48-72 hours)Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.
Outcome measures
| Measure |
Electronic Assisted Consent (EAC)
n=60 Participants
Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
|
Control Consent (FBC)
n=63 Participants
Form-based informed consent as performed by pediatric gastroenterologists
|
|---|---|---|
|
Questions Asked by Subjects (Parents)
|
2.03 Questions
Interval 0.0 to 14.0
|
3.06 Questions
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: At completion of studyOutcome measures
Outcome data not reported
Adverse Events
Electronic Assisted Consent (EAC)
Control Consent (FBC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joel A Friedlander
Children's Hospital of Philadelphia/OHSU/Doernbecher Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place