Examining Health Literacy in Biorepository Consents

NCT04953169 | Withdrawn

• 1 other identifier: 2017-1092
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research has shown that most parents would allow their child's leftover blood to be included in a de-identified biorepository using opt-out consent in an outpatient setting. In a pilot study to evaluate Pediatric Intensive Care Unit (PICU) parents' preferences and comprehension of a written opt-in consent to include their child's sample in a biorepository, the investigators showed 19% of parents did not agree to participate in the Biobank, more than the 8.7% reported in other settings. Parent comprehension varied. and the investigators also noted differential enrollment by sociodemographic factors. Critically ill children and their parents are vulnerable; seeking consent for non-therapeutic research in critical care requires special consideration. Therefore, the goal of this study is to evaluate whether the addition of a stakeholder influenced (parent, clinical research professionals) video aided consent will improve comprehension and rates of enrollment across diverse groups in this high intensity setting.

Conditions

Pediatric; Critical Illness; Consent

Outcome Measures

Primary Outcomes (1)

• Rates of enrollment into a biorepository based on consent type

  Number of eligible individuals who enroll between groups that watch a biobanking video and those who only receive written consent documents

  Admission to Discharge from PICU (anticipated up to 6 months but will vary by participant)

Secondary Outcomes (21)

• Parent Race Questionnaire

  Baseline 1 time data at time of enrollment

• Child Race Chart Extraction

  Baseline 1 time data at time of enrollment

• Parent Ethnicity Questionnaire

  Baseline 1 time data at time of enrollment

• Child Ethnicity Chart Extraction

  Baseline 1 time data at time of enrollment

• Parent age Questionnaire

  Baseline 1 time data at time of enrollment

Study Arms (2)

Video

OTHER

The video is information regarding biobanking

Other: Biobank Video

Non-Video

OTHER

The non-video group will receive a written informed consent

Other: Non-Video

Interventions

Biobank Video OTHER

The video describes the process of biobanking with visuals

Video

Non-Video OTHER

The non-video group will receive a written informed consent

Non-Video

Eligibility Criteria

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

You may qualify if:

• Parents of patients who are nearing readiness for discharge/clinically stable to participate

You may not qualify if:

• Other Languages Except For English and Spanish

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

Related Publications (10)

• Menon K, Ward R; Canadian Critical Care Trials Group. A study of consent for participation in a non-therapeutic study in the pediatric intensive care population. J Med Ethics. 2014 Feb;40(2):123-6. doi: 10.1136/medethics-2012-101075. Epub 2013 Jan 23.

  PMID: 23345569 BACKGROUND

• McGregor TL, Van Driest SL, Brothers KB, Bowton EA, Muglia LJ, Roden DM. Inclusion of pediatric samples in an opt-out biorepository linking DNA to de-identified medical records: pediatric BioVU. Clin Pharmacol Ther. 2013 Feb;93(2):204-11. doi: 10.1038/clpt.2012.230. Epub 2012 Nov 21.

  PMID: 23281421 BACKGROUND

• Federal Policy for the Protection of Human Subjects. 45 CFR 46. September 8, 2015 2015;80(173):53933-54061.

  BACKGROUND

• Carman KL, Heeringa JW, Heil SKR, Garfinkel S, Windham A, Gilmore D, Ginsburg M, Sofaer S, Gold M, Pathak-Sen E.. Public Deliberation To Elicit Input on Health Topics: Findings From a Literature Review. Executive Summary. (Prepared by American Institutes for Research under Contract No. 290-2010-000005). AHRQ Publication No. EHC 13-070-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; February 2013. www.effectivehealthcare.ahrq.gov.

  BACKGROUND

• Rodriguez-Rey R, Alonso-Tapia J. Development of a screening measure of stress for parents of children hospitalised in a Paediatric Intensive Care Unit. Aust Crit Care. 2016 Aug;29(3):151-7. doi: 10.1016/j.aucc.2015.11.002. Epub 2015 Dec 12.

  PMID: 26692497 BACKGROUND

• BRIEF Health Literacy Screen: https://healthliteracy.bu.edu/brief

  BACKGROUND

• Child and Parent Understanding of Clinical Trials: The Semi-Structured Comprehension Interview; Paquette E.T., Najita J., Morley D., Joffe S.; (2015) AJOB Empirical Bioethics, 6 (2) , pp. 23-32.

  BACKGROUND

• PEMAT AV: https://www.ahrq.gov/ncepcr/tools/self-mgmt/pemat-av.html

  BACKGROUND

• PEMAT PRINT: https://www.ahrq.gov/ncepcr/tools/self-mgmt/pemat-p.html

  BACKGROUND

• Corbie-Smith G, Thomas SB, St George DM. Distrust, race, and research. Arch Intern Med. 2002 Nov 25;162(21):2458-63. doi: 10.1001/archinte.162.21.2458.

  PMID: 12437405 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Paquette, MD, JD, MBe

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each participant will be randomly be assigned either the video or the written consent.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics (Critical Care)

Model Details: Intervention: Study participants will be randomized to one of two forms of consent for participation in a biorepository as part of another study in the PICU. One version of consent will be the standard consent used in the study for which they are eligible. The second version of consent will present the standard consent + a biobanking video. The primary outcome will be to assess enrollment in the biorepository based upon consent version. Because the participants will be randomly assigned to groups and this may impact their behavior regarding enrollment in the biorepository, it is an interventional design. Secondary outcomes and factors which may correlate with participation will be assessed using qualitative and quantitative measures through an electronic survey. A survey contains questions that will measure knowledge, comprehension, retention, and evaluation of two modes of information delivery, the video + written consent and written information only.

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2021
• Study Start: July 13, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)