Examining Health Literacy in Biorepository Consents

Critical Illness Clinical Trial

Official title:

Examining Health Literacy in Biorepository Consents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953169
• Other study ID #: 2017-1092
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Erin Paquette, MD, JD, MBe
• Phone: 312-227-4000
• Email: EPaquette[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Other Languages Except For English and Spanish

Related Conditions & MeSH terms

• Consent
• Critical Illness
• Pediatric

Intervention

Other:
• Biobank Video
The video describes the process of biobanking with visuals
• Non-Video
The non-video group will receive a written informed consent

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

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.

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.

Corbie-Smith G, Thomas SB, St George DM. Distrust, race, and research. Arch Intern Med. 2002 Nov 25;162(21):2458-63. — View Citation

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

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. — View 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. — View Citation

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

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

Rodríguez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parent Race Questionnaire	Parent self-reported race (US Census Categories)	Baseline 1 time data at time of enrollment
Secondary	Child Race Chart Extraction	Child race in electronic medical record	Baseline 1 time data at time of enrollment
Secondary	Parent Ethnicity Questionnaire	Parent self-reported ethnicity (US Census Categories)	Baseline 1 time data at time of enrollment
Secondary	Child Ethnicity Chart Extraction	Child ethnicity in electronic medical record	Baseline 1 time data at time of enrollment
Secondary	Parent age Questionnaire	Parent self-reported age in years	Baseline 1 time data at time of enrollment
Secondary	Child age Chart Extraction	Child age in years in electronic medical record	Baseline 1 time data at time of enrollment
Secondary	Child gender Chart Extraction	Child gender in electronic medical record	Baseline 1 time data at time of enrollment
Secondary	Parent gender Questionnaire	Parent self-reported gender	Baseline 1 time data at time of enrollment
Secondary	Parent Education Level Questionnaire	Parent self-reported highest level of education	Baseline 1 time data at time of enrollment
Secondary	Parent Primary Language Questionnaire	Parent self-reported language	Baseline 1 time data at time of enrollment
Secondary	Health Literacy - Parent Self Report on BRIEF Questionnaire	Four question item completed by parent self report on a Likert scale of familiarity and comfort with health information and completion of medical forms. Three items are scored as: always/often/sometimes/occasionally/never; the last item is scored as not at all/a little bit/somewhat/quite a bit/extremely. Each category is scored 1-5 (in order of how they are written). Higher scores indicate greater health literacy.	Baseline 1 time data at the time of enrollment
Secondary	Health Literacy - Flesch Kincaid Reading Level	Consent form grade reading level	Baseline 1 time data at the time of enrollment
Secondary	Knowledge about biobanking Questionnaire - Semi Structured Comprehension Interview	Six question open ended response assessment about the purpose, procedures, risks, benefits, voluntariness, and ability to withdraw from the biorepository. Answers are scored 0,1,2 based on whether they are incorrect, correct but incomplete, or correct and complete.	2 times - at enrollment (baseline recall/knowledge) and discharge from PICU (retention), expected up to 1 year
Secondary	Satisfaction with the information provided Questionnaire	8 item questionnaire regarding their satisfaction with the video, with each question rated strongly agree/agree/neutral/disagree/strongly disagree	Baseline 1 time data at the time of enrollment
Secondary	Satisfaction with understandability Questionnaire - PEMAT-AV for video recipients	The Patient Education Materials Assessment Tool-Audiovisual is an Agency for Healthcare Quality and Research tool to judge the understandability of audiovisual materials. Relevant questions from a list of available questions can be asked of individuals reviewing AV materials. Each item is ranked agree (1) /disagree (0)/not applicable. The total number of agree/disagree scores are summed and divided by the number of items completed and then multiplied by 100 to get a percentage score of understandability of the materials.	Baseline 1 time data at the time of enrollment
Secondary	Satisfaction with understandability Questionnaire - PEMAT-Print for standard consent recipients	The Patient Education Materials Assessment Tool-Print is an Agency for Healthcare Quality and Research tool to judge the understandability of written materials. Relevant questions from a list of available questions can be asked of individuals reviewing written materials. Each item is ranked agree (1) /disagree (0)/not applicable. The total number of agree/disagree scores are summed and divided by the number of items completed and then multiplied by 100 to get a percentage score of understandability of the materials.	Baseline 1 time data at the time of enrollment
Secondary	What motivated participation - most important factor from Parent Questionnaire	Parent selection from pre-determined categories of most important factor motivating research participation	Baseline 1 time data at the time of enrollment
Secondary	What motivated participation - factors that played a role from parent questionnaire	Survey respondents complete 11 item questionnaire that ranks factors that played a role in their decision as strongly agree/agree/neutral/disagree/strongly disagree.	Baseline 1 time data at the time of enrollment
Secondary	Parental Anxiety Questionnaire Abbreviated Parental Stress Scale: PICU (A-PSS PICU):	7 item measure that assesses environmental factors in the PICU that can contribute to parent stress. Each item is rated on a scale of not experienced/not stressful/minimally stressful/moderately stressful/extremely stressful.	Baseline 1 time data at the time of enrollment.
Secondary	Parental Trust in the Health System/Research Questionnaire	Seven question measure of trust in their physician related to research. Four questions ask about physician explanation of research, ability to ask questions about research, physician recommendations about research if they feel it will cause harm, and whether physicians have ever given treatment as an experiment without consent rated on a Yes/No/I don't know scale. One question asks about whether physicians will prevent unnecessary risk, rated as protect me from risk/sometimes expose me to risk/I don't know. One question asks about whether people will be used as guinea pigs without consent rated as Not at all likely/somewhat likely/Very likely/I don't know. One question asks about prescribing medications as an experiment without consent with choices Not at all/fairly often/Very Often/I don't know.	baseline 1 time data at the time of enrollment
Secondary	Satisfaction with decision regarding biorepository enrollment Questionnaire - Decision Regret Scale	Parents will complete 5 questions on a scale rated strongly agree, agree, neither agree nor disagree, disagree or strongly disagree for each question. Questions assess whether it was the right decision, whether there is any regret, whether they would make the same choice, whther the choice did harm, and whether the choice was a wise one.	discharge data - 1 time data at the time of PICU discharge, expected up to 1 year