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Examining Health Literacy in Biorepository Consents

NCT04953169 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-19

No results posted yet for this study

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

Interventions

OTHER

Biobank Video

The video describes the process of biobanking with visuals

OTHER

Non-Video

The non-video group will receive a written informed consent

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Erin Paquette, MD, JD, MBe · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04953169 on ClinicalTrials.gov