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

NCT03141307 | Completed Results

• 2 other identifiers: 813521R01HD082148
• Study Type: interventional
• Target: 711
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Neonatal Screening

Keywords

Neonatal screening; Biobank; Broad Consent

Outcome Measures

Primary Outcomes (1)

• 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.

  Administered immediately after the intervention

Secondary Outcomes (5)

• Quality of Informed Consent

  Administered immediately after the intervention

• Attitudes Survey

  Administered at the 2-4 week follow-up

• Residual Comprehension for Biobanking

  Administered at the 2-4 week follow-up

• Residual Quality of Informed Consent

  Administered at the 2-4 week follow-up

• Residual Decisional Regret

  Administered at the 2-4 week follow-up

Study Arms (2)

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.

Behavioral: EICI Movie; Behavioral: EICI App

Control

PLACEBO COMPARATOR

This group will receive the standard of care currently used (paper-based brochure)

Behavioral: Control

Interventions

EICI Movie BEHAVIORAL

The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.

Intervention

EICI App BEHAVIORAL

The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.

Intervention

Control BEHAVIORAL

Standard of care, paper-based brochure

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Michigan Department of Health & Human Services

Lansing, Michigan, 48913, United States

Location

Related Publications (4)

• 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.

  PMID: 11734235 BACKGROUND

• Beskow 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.

  PMID: 25144889 BACKGROUND

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

  PMID: 7898294 BACKGROUND

• Rothwell 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.

  PMID: 32242760 DERIVED

Results Point of Contact

• Title: Dr. Bob Wong
• Organization: University of Utah

bob.wong@nurs.utah.edu

801-587-9666

Study Officials

• Erin Rothwell, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Jeffrey Botkin, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 5, 2017
• Study Start: March 1, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: October 1, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)