Examining Health Literacy in Biorepository Consents

NCT ID: NCT04953169

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2021-06-30

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.

Detailed Description

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.

Previous research showed 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. Critically ill children and their parents are vulnerable; seeking consent for non-therapeutic research in critical care requires special consideration. 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; in general, parents understood the voluntary nature of participation but had limited knowledge of the purposes, risks, and benefits of biorepository research. The investigators showed in an initial single page opt-in consent low rates of comprehension. The investigators also showed differential enrollment by socioeconomic status factors. 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 a pediatric biorepository. To achieve this goal, the study will occur in two phases: first, the investigators will pilot test a survey with up to 20 participants; based on the results of the pilot the investigators will amend the survey, if and as needed, and then begin a larger enrollment.

Conditions

Pediatric; Critical Illness; Consent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Video

The video is information regarding biobanking

Group Type: OTHER

Biobank Video

Intervention Type: OTHER

The video describes the process of biobanking with visuals

Non-Video

The non-video group will receive a written informed consent

Group Type: OTHER

Non-Video

Intervention Type: OTHER

The non-video group will receive a written informed consent

Interventions

Biobank Video

The video describes the process of biobanking with visuals

Intervention Type: OTHER

Non-Video

The non-video group will receive a written informed consent

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Other Languages Except For English and Spanish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Erin Paquette

Assistant Professor of Pediatrics (Critical Care)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin Paquette, MD, JD, MBe

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23345569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23281421 (View on PubMed)

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

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26692497 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 12437405 (View on PubMed)

Other Identifiers

2017-1092

Identifier Type: -

Identifier Source: org_study_id