The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research (EICI)

September 27, 2019 updated by: Erin Rothwell, University of Utah

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

711

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Lansing, Michigan, United States, 48913
        • Michigan Department of Health & Human Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria

  • 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

Exclusion criteria

  • Newborn baby is in the NICU
  • Unable to speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Behavioral: EICI Movie
The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
Behavioral: EICI App
The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
PLACEBO_COMPARATOR: Control
This group will receive the standard of care currently used (paper-based brochure)
Behavioral: Control
Standard of care, paper-based brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Administered immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Informed Consent
Time Frame: Administered immediately after the intervention
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.
Administered immediately after the intervention
Attitudes Survey
Time Frame: Administered at the 2-4 week follow-up
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
Administered at the 2-4 week follow-up
Residual Comprehension for Biobanking
Time Frame: Administered at the 2-4 week follow-up

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.
Administered at the 2-4 week follow-up
Residual Quality of Informed Consent
Time Frame: Administered at the 2-4 week follow-up

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.
Administered at the 2-4 week follow-up
Residual Decisional Regret
Time Frame: Administered at the 2-4 week follow-up
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.
Administered at the 2-4 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Michigan Department of Health and Human Services

Investigators

  • Principal Investigator: Jeffrey Botkin, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

June 15, 2018

Study Completion (ACTUAL)

June 15, 2018

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 81352
  • 1R01HD082148 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data regarding knowledge about retention of newborn screening dried bloodspots is not useful data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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