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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
The video describes the process of biobanking with visuals
The non-video group will receive a written informed consent
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
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
Time frame: Admission to Discharge from PICU (anticipated up to 6 months but will vary by participant)
Parent Race Questionnaire
Parent self-reported race (US Census Categories)
Time frame: Baseline 1 time data at time of enrollment
Child Race Chart Extraction
Child race in electronic medical record
Time frame: Baseline 1 time data at time of enrollment
Parent Ethnicity Questionnaire
Parent self-reported ethnicity (US Census Categories)
Time frame: Baseline 1 time data at time of enrollment
Child Ethnicity Chart Extraction
Child ethnicity in electronic medical record
Time frame: Baseline 1 time data at time of enrollment
Parent age Questionnaire
Parent self-reported age in years
Time frame: Baseline 1 time data at time of enrollment
Child age Chart Extraction
Child age in years in electronic medical record
Time frame: Baseline 1 time data at time of enrollment
Child gender Chart Extraction
Child gender in electronic medical record
Time frame: Baseline 1 time data at time of enrollment
Parent gender Questionnaire
Parent self-reported gender
Time frame: Baseline 1 time data at time of enrollment
Parent Education Level Questionnaire
Parent self-reported highest level of education
Time frame: Baseline 1 time data at time of enrollment
Parent Primary Language Questionnaire
Parent self-reported language
Time frame: Baseline 1 time data at time of enrollment
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.
Time frame: Baseline 1 time data at the time of enrollment
Health Literacy - Flesch Kincaid Reading Level
Consent form grade reading level
Time frame: Baseline 1 time data at the time of enrollment
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.
Time frame: 2 times - at enrollment (baseline recall/knowledge) and discharge from PICU (retention), expected up to 1 year
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
Time frame: Baseline 1 time data at the time of enrollment
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.
Time frame: Baseline 1 time data at the time of enrollment
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.
Time frame: Baseline 1 time data at the time of enrollment
What motivated participation - most important factor from Parent Questionnaire
Parent selection from pre-determined categories of most important factor motivating research participation
Time frame: Baseline 1 time data at the time of enrollment
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.
Time frame: Baseline 1 time data at the time of enrollment
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.
Time frame: Baseline 1 time data at the time of enrollment.
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.
Time frame: baseline 1 time data at the time of enrollment
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.
Time frame: discharge data - 1 time data at the time of PICU discharge, expected up to 1 year
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