Examining Health Literacy in Biorepository Consents
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Rates of enrollment into a biorepository based on consent type
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Each participant will be randomly be assigned either the video or the written consent.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of patients who are nearing readiness for discharge/clinically stable to participate
排除标准
- •Other Languages Except For English and Spanish
结局指标
主要结局
Rates of enrollment into a biorepository based on consent type
时间窗: Admission to Discharge from PICU (anticipated up to 6 months but will vary by participant)
Number of eligible individuals who enroll between groups that watch a biobanking video and those who only receive written consent documents
次要结局
- Child Race Chart Extraction(Baseline 1 time data at time of enrollment)
- Parent Ethnicity Questionnaire(Baseline 1 time data at time of enrollment)
- Parent Education Level Questionnaire(Baseline 1 time data at time of enrollment)
- Knowledge about biobanking Questionnaire - Semi Structured Comprehension Interview(2 times - at enrollment (baseline recall/knowledge) and discharge from PICU (retention), expected up to 1 year)
- Satisfaction with understandability Questionnaire - PEMAT-AV for video recipients(Baseline 1 time data at the time of enrollment)
- Parent age Questionnaire(Baseline 1 time data at time of enrollment)
- Parent gender Questionnaire(Baseline 1 time data at time of enrollment)
- Health Literacy - Flesch Kincaid Reading Level(Baseline 1 time data at the time of enrollment)
- Parent Race Questionnaire(Baseline 1 time data at time of enrollment)
- Parent Primary Language Questionnaire(Baseline 1 time data at time of enrollment)
- Satisfaction with understandability Questionnaire - PEMAT-Print for standard consent recipients(Baseline 1 time data at the time of enrollment)
- What motivated participation - most important factor from Parent Questionnaire(Baseline 1 time data at the time of enrollment)
- Child age Chart Extraction(Baseline 1 time data at time of enrollment)
- Child gender Chart Extraction(Baseline 1 time data at time of enrollment)
- Child Ethnicity Chart Extraction(Baseline 1 time data at time of enrollment)
- Health Literacy - Parent Self Report on BRIEF Questionnaire(Baseline 1 time data at the time of enrollment)
- Satisfaction with the information provided Questionnaire(Baseline 1 time data at the time of enrollment)
- What motivated participation - factors that played a role from parent questionnaire(Baseline 1 time data at the time of enrollment)
- Parental Anxiety Questionnaire Abbreviated Parental Stress Scale: PICU (A-PSS PICU):(Baseline 1 time data at the time of enrollment.)
- Parental Trust in the Health System/Research Questionnaire(baseline 1 time data at the time of enrollment)
- Satisfaction with decision regarding biorepository enrollment Questionnaire - Decision Regret Scale(discharge data - 1 time data at the time of PICU discharge, expected up to 1 year)
研究者
Erin Paquette
Assistant Professor of Pediatrics (Critical Care)
Ann & Robert H Lurie Children's Hospital of Chicago