Neonatal ScreeningEICINCT03141307
The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research
A study testing EICI Movie and EICI App in people with Neonatal Screening, run by University of Utah at 1 site in United States.
Trial summary
Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neonatal Screening
- What is being tested?
- EICI Movie and EICI App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 15 Jun 2018
- 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
- adult (> 18 years)
- English-speaking
- Recently given birth and are already being approached for participation in the Michigan BioTrust.
- Partner of woman who has recently given birth and is already being approached for participation in the Michigan BioTrust
Who cannot join
- Newborn baby is in the NICU
- Unable to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Department of Health & Human Services
Lansing, Michigan, 48913
About this study
Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs choose to store these specimens for several uses including biomedical research. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinical setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during postpartum clinical care, will be recruited and randomized to one of three groups. Specific Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing hospitals and Department of Community Health staff before and after the intervention.
- Hypothesis 1) Women in the Interactive technology group (Group A) and the video group (Group B) will demonstrate higher knowledge at Time 1 and Time 2 about the consent elements and the BioTrust than those who do not receive either EICI tool (Group C).
- Hypothesis 2) Women in the EICI groups (Groups A and B) will demonstrate lower decisional conflict at Time 1 and Time 2 toward biobanking than those who do not receive the EICI (Group C).
- Hypothesis 3) Women in the EICI groups (Groups A and B) will not differ significantly in their choices about biobanking and attitudes toward NBS and biobank research compared to participants who do not receive EICI tool (Group C).
Read the detailed description
For the intervention, a research assistant (RA) at each hospital, with permission of the healthcare professional, will ask potential participants if they are interested in participating in this study. If they are interested, the RAs will seek verbal consent for this study at this time. The RA will inform patients that when a healthcare provider comes into their room about the BioTrust, they will have the study information for them.
Then the RAs at the labor and deliver units of the hospitals will give an iPad to the healthcare providers seeking consent for the BioTrust. The healthcare providers will be blind to the study group assignment until they enter the patient's room. When a healthcare professional enters a patients' room, she will touch the iPad to see the study group assignment. Participants will be randomized to one of three study groups and this will be programmed automatically on the iPad. If they are in Group A or B, the healthcare providers will give the iPad to the patients to watch or read the consent information. If they are in Group C (control group) the standard brochure will be given about the BioTrust. Immediately following their decision, all participants will complete a brief knowledge survey on the iPad.
This recruitment approach mirrors the current clinical encounter for the BioTrust. This current approach is as follows. After newborn screening is completed, a healthcare professional approaches the mother in the hospital and provides them with the Michigan BioTrust brochure (see appendix) and then asks for the mother to consent to allow or not allow their infants' residual DBS to be stored in the Michigan BioTrust. This consent form is a simply check for yes and no with their signature and is attached to the back of the newborn screening card. For this study, after they receive the information in any of the study groups, all participants will still be required to sign this same consent form because it is attached to the physical sample of the newborn screening blood specimens.
All participating women will complete a survey 1) immediately following the intervention/control on the electronic table (Time 1) and 2) also will be surveyed by telephone 2-4 weeks follow up (Time 2).
Drs. Rothwell, Johnson and Tarini will provide guidance for the coordination of the clinical sites, due to their extensive experience. To ensure success there will be at least weekly communication between the sites and the Project Director, Dr. Johnson and monthly among the site personnel. Drs. Botkin, Rothwell and Johnson will visit each site prior to implementation of data collection to introduce the project and discuss issues sites may have. Once the RAs have been hired at each site they will provide weekly reports of activities and recruitment to the Research team in Utah. Monthly a teleconference will be held and the Site PI's will report on activities and recruitment to the Utah research team and the other site PI. Consistency among the sites will be monitored with these reports and communication strategies. Research team coordination with communication and meetings is based on the successful accomplishment of previous research project (R01 HD058854).
- Conditions
- Neonatal Screening
- Being tested
- EICI Movie, EICI App, Control
- Keywords
- Neonatal screening, Biobank, Broad Consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EICI MovieBehavioural
The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
EICI AppBehavioural
The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
ControlBehavioural
Standard of care, paper-based brochure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Behavioral: EICI Movie; Behavioral: EICI App |
| Control | Placebo comparator | This group will receive the standard of care currently used (paper-based brochure) Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension for Biobanking at Time of Consent
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.
Measured: Administered immediately after the intervention
Secondary outcomes (5)
Quality of Informed Consent
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.
Measured: Administered immediately after the intervention
Attitudes 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
Measured: Administered at the 2-4 week follow-up
Residual Comprehension for Biobanking
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.
Measured: Administered at the 2-4 week follow-up
Residual Quality of Informed Consent
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.
Measured: Administered at the 2-4 week follow-up
Residual Decisional Regret
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.
Measured: Administered at the 2-4 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Mar 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal ScreeningStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services, Case Western Reserve University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Erin Rothwell, University of Utah
- Investigators
- Erin Rothwell, PhD, Principal investigator, University of UtahJeffrey Botkin, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141307
- Sponsor's protocol ID
- 81352
- Other IDs
- 1R01HD082148
- Acronym
- EICI
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2017
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data regarding knowledge about retention of newborn screening dried bloodspots is not useful data
Publications
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001 Nov 24;358(9295):1772-7. doi: 10.1016/S0140-6736(01)06805-2.
PubMed 11734235Beskow LM, Dombeck CB, Thompson CP, Watson-Ormond JK, Weinfurt KP. Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet Med. 2015 Mar;17(3):226-33. doi: 10.1038/gim.2014.102. Epub 2014 Aug 21.
PubMed 25144889O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Rothwell E, Johnson E, Wong B, Goldenberg A, Tarini BA, Riches N, Stark LA, Pries C, Langbo C, Langen E, Botkin J. Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial. J Empir Res Hum Res Ethics. 2020 Oct;15(4):252-260. doi: 10.1177/1556264620913455. Epub 2020 Apr 3.
PubMed 32242760
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research
- ClinicalTrials.gov ID
- NCT03141307
- Acronym / sponsor ID
- EICI / 81352
- Conditions
- Neonatal Screening
- Keywords
- Neonatal screening, Biobank, Broad Consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services, Case Western Reserve University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs choose to store these specimens for several uses including biomedical research. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinical setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during postpartum clinical care, will be recruited and randomized to one of three groups. Specific Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing hospitals and Department of Community Health staff before and after the intervention.
- Hypothesis 1) Women in the Interactive technology group (Group A) and the video group (Group B) will demonstrate higher knowledge at Time 1 and Time 2 about the consent elements and the BioTrust than those who do not receive either EICI tool (Group C).
- Hypothesis 2) Women in the EICI groups (Groups A and B) will demonstrate lower decisional conflict at Time 1 and Time 2 toward biobanking than those who do not receive the EICI (Group C).
- Hypothesis 3) Women in the EICI groups (Groups A and B) will not differ significantly in their choices about biobanking and attitudes toward NBS and biobank research compared to participants who do not receive EICI tool (Group C).
Detailed description
For the intervention, a research assistant (RA) at each hospital, with permission of the healthcare professional, will ask potential participants if they are interested in participating in this study. If they are interested, the RAs will seek verbal consent for this study at this time. The RA will inform patients that when a healthcare provider comes into their room about the BioTrust, they will have the study information for them.
Then the RAs at the labor and deliver units of the hospitals will give an iPad to the healthcare providers seeking consent for the BioTrust. The healthcare providers will be blind to the study group assignment until they enter the patient's room. When a healthcare professional enters a patients' room, she will touch the iPad to see the study group assignment. Participants will be randomized to one of three study groups and this will be programmed automatically on the iPad. If they are in Group A or B, the healthcare providers will give the iPad to the patients to watch or read the consent information. If they are in Group C (control group) the standard brochure will be given about the BioTrust. Immediately following their decision, all participants will complete a brief knowledge survey on the iPad.
This recruitment approach mirrors the current clinical encounter for the BioTrust. This current approach is as follows. After newborn screening is completed, a healthcare professional approaches the mother in the hospital and provides them with the Michigan BioTrust brochure (see appendix) and then asks for the mother to consent to allow or not allow their infants' residual DBS to be stored in the Michigan BioTrust. This consent form is a simply check for yes and no with their signature and is attached to the back of the newborn screening card. For this study, after they receive the information in any of the study groups, all participants will still be required to sign this same consent form because it is attached to the physical sample of the newborn screening blood specimens.
All participating women will complete a survey 1) immediately following the intervention/control on the electronic table (Time 1) and 2) also will be surveyed by telephone 2-4 weeks follow up (Time 2).
Drs. Rothwell, Johnson and Tarini will provide guidance for the coordination of the clinical sites, due to their extensive experience. To ensure success there will be at least weekly communication between the sites and the Project Director, Dr. Johnson and monthly among the site personnel. Drs. Botkin, Rothwell and Johnson will visit each site prior to implementation of data collection to introduce the project and discuss issues sites may have. Once the RAs have been hired at each site they will provide weekly reports of activities and recruitment to the Research team in Utah. Monthly a teleconference will be held and the Site PI's will report on activities and recruitment to the Utah research team and the other site PI. Consistency among the sites will be monitored with these reports and communication strategies. Research team coordination with communication and meetings is based on the successful accomplishment of previous research project (R01 HD058854).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: EICI Movie, Behavioral: EICI AppThe 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. |
| Control | Placebo comparator | Behavioral: ControlThis group will receive the standard of care currently used (paper-based brochure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult (> 18 years)
- English-speaking
- Recently given birth and are already being approached for participation in the Michigan BioTrust.
- Partner of woman who has recently given birth and is already being approached for participation in the Michigan BioTrust
Key exclusion criteria (2 listed)
- Newborn baby is in the NICU
- Unable to speak English
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 |
|---|---|---|
| EICI MovieThe purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video. | Behavioural | Intervention |
| EICI AppThe purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app. | Behavioural | Intervention |
| ControlStandard of care, paper-based brochure | Behavioural | Control |
Primary outcome
Comprehension for Biobanking at Time of Consent
Time frame: Administered immediately after the intervention
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.
5 secondary outcomes
Quality of Informed Consent
Time frame: Administered immediately after the intervention
Attitudes Survey
Time frame: Administered at the 2-4 week follow-up
Residual Comprehension for Biobanking
Time frame: Administered at the 2-4 week follow-up
Residual Quality of Informed Consent
Time frame: Administered at the 2-4 week follow-up
Residual Decisional Regret
Time frame: Administered at the 2-4 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11734235Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001 Nov 24;358(9295):1772-7. doi: 10.1016/S0140-6736(01)06805-2.
- Background: PubMed 25144889Beskow LM, Dombeck CB, Thompson CP, Watson-Ormond JK, Weinfurt KP. Informed consent for biobanking: consensus-based guidelines for adequate comprehension. Genet Med. 2015 Mar;17(3):226-33. doi: 10.1038/gim.2014.102. Epub 2014 Aug 21.
- Background: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Derived from this study: PubMed 32242760Rothwell E, Johnson E, Wong B, Goldenberg A, Tarini BA, Riches N, Stark LA, Pries C, Langbo C, Langen E, Botkin J. Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial. J Empir Res Hum Res Ethics. 2020 Oct;15(4):252-260. doi: 10.1177/1556264620913455. Epub 2020 Apr 3.
- Individual participant dataSharing planned: No. Individual data regarding knowledge about retention of newborn screening dried bloodspots is not useful data
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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.
Erin Rothwell, PhD principal investigator
University of Utah
Jeffrey Botkin, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EICI Movie and EICI App in people with Neonatal Screening, run by University of Utah 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 4 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 1 Oct 2019. 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. Some participants in this study may receive a placebo. 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 20 Sep 2019). 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?
Comprehension for Biobanking at Time of Consent (time frame: Administered immediately after the intervention). 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 NCT03141307, which also lists 4 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 1 Oct 2019.