Trial Outcomes & Findings for The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research (NCT NCT03141307)
NCT ID: NCT03141307
Last Updated: 2019-10-01
Results Overview
Questions based on the 16-item biobank checklist developed from consensus-based guidelines for adequate comprehension for biobanking (see Beskow et al. 2014). This measure assesses a person's understanding of the Michigan BioTrust program. Scale range: 0-1 The reported scale is derived from the number of correct answers divided by 20 for a percentage correct. Thus, a score of .6 indicates a 60% correct response rate. Higher values indicate more comprehension of the presented information. Lower values indicate less comprehension of the presented information.
COMPLETED
NA
711 participants
Administered immediately after the intervention
2019-10-01
Participant Flow
Participant milestones
| Measure |
Intervention
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
In-Hospital
STARTED
|
471
|
240
|
|
In-Hospital
COMPLETED
|
467
|
238
|
|
In-Hospital
NOT COMPLETED
|
4
|
2
|
|
Follow-Up
STARTED
|
467
|
238
|
|
Follow-Up
COMPLETED
|
370
|
184
|
|
Follow-Up
NOT COMPLETED
|
97
|
54
|
Reasons for withdrawal
| Measure |
Intervention
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
In-Hospital
Withdrawal by Subject
|
0
|
2
|
|
In-Hospital
Protocol Violation
|
4
|
0
|
|
Follow-Up
Lost to Follow-up
|
97
|
54
|
Baseline Characteristics
The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research
Baseline characteristics by cohort
| Measure |
Intervention
n=471 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=240 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
Total
n=711 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
362 Participants
n=39 Participants
|
184 Participants
n=41 Participants
|
546 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
471 participants
n=39 Participants
|
240 participants
n=41 Participants
|
711 participants
n=35 Participants
|
|
Age, Continuous
|
29.78 years
STANDARD_DEVIATION 4.92 • n=39 Participants
|
30.53 years
STANDARD_DEVIATION 4.76 • n=41 Participants
|
30.03 years
STANDARD_DEVIATION 4.86 • n=35 Participants
|
|
Sex: Female, Male
Female
|
432 Participants
n=39 Participants
|
228 Participants
n=41 Participants
|
660 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
433 Participants
n=39 Participants
|
225 Participants
n=41 Participants
|
658 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Administered immediately after the interventionPopulation: The analysis population differs from the number of participants enrolled because the initial 15 to 20 participants at each hospital were considered to be run-in participants during which the protocol was evaluated for its effectiveness at that site and adjusted as needed. Our analysis plan was written to exclude these run-in participants.
Questions based on the 16-item biobank checklist developed from consensus-based guidelines for adequate comprehension for biobanking (see Beskow et al. 2014). This measure assesses a person's understanding of the Michigan BioTrust program. Scale range: 0-1 The reported scale is derived from the number of correct answers divided by 20 for a percentage correct. Thus, a score of .6 indicates a 60% correct response rate. Higher values indicate more comprehension of the presented information. Lower values indicate less comprehension of the presented information.
Outcome measures
| Measure |
Intervention
n=444 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=225 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
Comprehension for Biobanking at Time of Consent
|
.699 score on a scale
Standard Deviation .133
|
.645 score on a scale
Standard Deviation .172
|
SECONDARY outcome
Timeframe: Administered immediately after the interventionPopulation: The analysis population differs from the number of participants enrolled because the initial 15 to 20 participants at each hospital were considered to be run-in participants during which the protocol was evaluated for its effectiveness at that site and adjusted as needed. Our analysis plan was written to exclude these run-in participants.
The Quality of Informed Consent assesses how well the participant self-reports their understanding different aspects of the study he/she consented into (Joffe et al., 2001). Scores range from 1 to 5 with higher scores indicating better self-reported understanding of the elements of consent. The scale is created by taking the mean of 14 items.
Outcome measures
| Measure |
Intervention
n=442 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=222 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
Quality of Informed Consent
|
4.23 score on a scale
Standard Deviation .692
|
4.06 score on a scale
Standard Deviation .800
|
SECONDARY outcome
Timeframe: Administered at the 2-4 week follow-upPopulation: The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.
Assesses support of the Michigan BioTrust program. This is a single item assessment. Full scale range is 1 to 4. Higher values indicate more support of the Michigan BioTrust. The scale is a likert scale: 1 = Not supportive at all, 4 = Very supportive
Outcome measures
| Measure |
Intervention
n=338 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=167 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
Attitudes Survey
|
3.62 score on a scale
Standard Deviation .626
|
3.57 score on a scale
Standard Deviation .662
|
SECONDARY outcome
Timeframe: Administered at the 2-4 week follow-upPopulation: The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.
This is a repetition of the Comprehension for Biobanking survey assessed immediately after the intervention. The residual Comprehension for Biobanking survey assesses a person's retention of knowledge of the Michigan BioTrust program two to 4 weeks after the intervention. Scale range: 0-1 The reported scale is derived from the number of correct answers divided by 20 for a percentage correct. Thus, a score of .6 indicates a 60% correct response rate. Higher values indicate more comprehension of the presented information. Lower values indicate less comprehension of the presented information.
Outcome measures
| Measure |
Intervention
n=360 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=178 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
Residual Comprehension for Biobanking
|
.693 score on a scale
Standard Deviation .153
|
.667 score on a scale
Standard Deviation .159
|
SECONDARY outcome
Timeframe: Administered at the 2-4 week follow-upPopulation: The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.
Assessment of how well the participant understood different aspects of the study after a gap in time. The Residual Quality of Informed Consent is a repetition of the Quality of Informed Consent measure, now provided 2-4 weeks after the intervention. This measure assesses how well the participant self-reports their understanding different aspects of the study he/she consented into (Joffe et al., 2001). Scores range from 1 to 5 with higher scores indicating better self-reported understanding of the elements of consent. The scale is created by taking the mean of 14 items.
Outcome measures
| Measure |
Intervention
n=358 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=177 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
Residual Quality of Informed Consent
|
4.14 score on a scale
Standard Deviation .779
|
4.03 score on a scale
Standard Deviation .763
|
SECONDARY outcome
Timeframe: Administered at the 2-4 week follow-upPopulation: The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.
The Residual Decisional Regret measure assesses a person's feelings of regret after making a decision (in this specific case, participation in the Michigan BioTrust). Scores range from 1 to 5 with lower values indicating better outcomes due to less regret. The scale is created by taking the mean of 5 items.
Outcome measures
| Measure |
Intervention
n=356 Participants
The EICI intervention group will receive an electronic interactive tool with movie clips and external links available through the tool. The movie intervention group will watch the educational consent movie and receive the standard paper-based brochure.
EICI Movie: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI App: The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
|
Control
n=176 Participants
This group will receive the standard of care currently used (paper-based brochure)
Control: Standard of care, paper-based brochure
|
|---|---|---|
|
Residual Decisional Regret
|
1.74 units on a scale
Standard Deviation .866
|
1.60 units on a scale
Standard Deviation .623
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place