Examining Health Literacy in Biorepository Consents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Examining Health Literacy in Biorepository Consents

Conditions
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Consent, Pediatric, Critical Illness

Intervention / Treatment
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* Other: Biobank Video
* Other: Non-Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of patients who are nearing readiness for discharge/clinically stable to participate Exclusion Criteria: Other Languages Except For English and Spanish

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Video<br>The video is information regarding biobanking | Other: Biobank Video<br>* The video describes the process of biobanking with visuals<br>|
| Other: Non-Video<br>The non-video group will receive a written informed consent | Other: Non-Video<br>* The non-video group will receive a written informed consent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Race Questionnaire | Parent self-reported race (US Census Categories) | Baseline 1 time data at time of enrollment | 
| Child Race Chart Extraction | Child race in electronic medical record | Baseline 1 time data at time of enrollment | 
| Parent Ethnicity Questionnaire | Parent self-reported ethnicity (US Census Categories) | Baseline 1 time data at time of enrollment | 
| Child Ethnicity Chart Extraction | Child ethnicity in electronic medical record | Baseline 1 time data at time of enrollment | 
| Parent age Questionnaire | Parent self-reported age in years | Baseline 1 time data at time of enrollment | 
| Child age Chart Extraction | Child age in years in electronic medical record | Baseline 1 time data at time of enrollment | 
| Child gender Chart Extraction | Child gender in electronic medical record | Baseline 1 time data at time of enrollment | 
| Parent gender Questionnaire | Parent self-reported gender | Baseline 1 time data at time of enrollment | 
| Parent Education Level Questionnaire | Parent self-reported highest level of education | Baseline 1 time data at time of enrollment | 
| Parent Primary Language Questionnaire | Parent self-reported language | 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. | Baseline 1 time data at the time of enrollment | 
| Health Literacy - Flesch Kincaid Reading Level | Consent form grade reading level | 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. | 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 | 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. | 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. | 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 | 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. | 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. | 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. | 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. | discharge data - 1 time data at the time of PICU discharge, expected up to 1 year |