Clinical trial NCT04953169: Examining Health Literacy in Biorepository Consents
Official title: Examining Health Literacy in Biorepository Consents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pediatric
Critical Illness
Consent
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Rates of enrollment into a biorepository based on consent type
timeFrame: Admission to Discharge from PICU (anticipated up to 6 months but will vary by participant)
Secondary outcomes:
measure: Parent Race Questionnaire
timeFrame: Baseline 1 time data at time of enrollment
measure: Child Race Chart Extraction
timeFrame: Baseline 1 time data at time of enrollment
measure: Parent Ethnicity Questionnaire
timeFrame: Baseline 1 time data at time of enrollment
measure: Child Ethnicity Chart Extraction
timeFrame: Baseline 1 time data at time of enrollment
measure: Parent age Questionnaire
timeFrame: Baseline 1 time data at time of enrollment
measure: Child age Chart Extraction
timeFrame: Baseline 1 time data at time of enrollment
measure: Child gender Chart Extraction
timeFrame: Baseline 1 time data at time of enrollment
measure: Parent gender Questionnaire
timeFrame: Baseline 1 time data at time of enrollment
measure: Parent Education Level Questionnaire
timeFrame: Baseline 1 time data at time of enrollment
measure: Parent Primary Language Questionnaire
timeFrame: Baseline 1 time data at time of enrollment
measure: Health Literacy - Parent Self Report on BRIEF Questionnaire
timeFrame: Baseline 1 time data at the time of enrollment
measure: Health Literacy - Flesch Kincaid Reading Level
timeFrame: Baseline 1 time data at the time of enrollment
measure: Knowledge about biobanking Questionnaire - Semi Structured Comprehension Interview
timeFrame: 2 times - at enrollment (baseline recall/knowledge) and discharge from PICU (retention), expected up to 1 year
measure: Satisfaction with the information provided Questionnaire
timeFrame: Baseline 1 time data at the time of enrollment
measure: Satisfaction with understandability Questionnaire - PEMAT-AV for video recipients
timeFrame: Baseline 1 time data at the time of enrollment
measure: Satisfaction with understandability Questionnaire - PEMAT-Print for standard consent recipients
timeFrame: Baseline 1 time data at the time of enrollment
measure: What motivated participation - most important factor from Parent Questionnaire
timeFrame: Baseline 1 time data at the time of enrollment
measure: What motivated participation - factors that played a role from parent questionnaire
timeFrame: Baseline 1 time data at the time of enrollment
measure: Parental Anxiety Questionnaire Abbreviated Parental Stress Scale: PICU (A-PSS PICU):
timeFrame: Baseline 1 time data at the time of enrollment.
measure: Parental Trust in the Health System/Research Questionnaire
timeFrame: baseline 1 time data at the time of enrollment
measure: Satisfaction with decision regarding biorepository enrollment Questionnaire - Decision Regret Scale
timeFrame: discharge data - 1 time data at the time of PICU discharge, expected up to 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Erin Paquette, MD, JD, MBe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Federal Policy for the Protection of Human Subjects. 45 CFR 46. September 8, 2015 2015;80(173):53933-54061.
citation: 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.
citation: 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.
citation: BRIEF Health Literacy Screen: https://healthliteracy.bu.edu/brief
citation: 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.
citation: PEMAT AV: https://www.ahrq.gov/ncepcr/tools/self-mgmt/pemat-av.html
citation: PEMAT PRINT: https://www.ahrq.gov/ncepcr/tools/self-mgmt/pemat-p.html
citation: 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.