PediatricNCT04953169
Examining Health Literacy in Biorepository Consents
A study testing Biobank Video and Non-Video in people with Pediatric and Critical Illness, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric, Critical Illness, Consent
- What is being tested?
- Biobank Video and Non-Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of patients who are nearing readiness for discharge/clinically stable to participate
Who cannot join
- Other Languages Except For English and Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2991
About this study
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.
Read the 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.
- Conditions
- Pediatric, Critical Illness, Consent
- Being tested
- Biobank Video, Non-Video
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobank VideoOther
The video describes the process of biobanking with visuals
Non-VideoOther
The non-video group will receive a written informed consent
| Study group | Role | What they receive |
|---|---|---|
| Video | Other | The video is information regarding biobanking Receives: Other: Biobank Video |
| Non-Video | Other | The non-video group will receive a written informed consent Receives: Other: Non-Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Admission to Discharge from PICU (anticipated up to 6 months but will vary by participant)
Secondary outcomes (21)
Parent Race Questionnaire
Parent self-reported race (US Census Categories)
Measured: Baseline 1 time data at time of enrollment
Child Race Chart Extraction
Child race in electronic medical record
Measured: Baseline 1 time data at time of enrollment
Parent Ethnicity Questionnaire
Parent self-reported ethnicity (US Census Categories)
Measured: Baseline 1 time data at time of enrollment
Child Ethnicity Chart Extraction
Child ethnicity in electronic medical record
Measured: Baseline 1 time data at time of enrollment
Parent age Questionnaire
Parent self-reported age in years
Measured: Baseline 1 time data at time of enrollment
Child age Chart Extraction
Child age in years in electronic medical record
Measured: Baseline 1 time data at time of enrollment
Child gender Chart Extraction
Child gender in electronic medical record
Measured: Baseline 1 time data at time of enrollment
Parent gender Questionnaire
Parent self-reported gender
Measured: Baseline 1 time data at time of enrollment
Parent Education Level Questionnaire
Parent self-reported highest level of education
Measured: Baseline 1 time data at time of enrollment
Parent Primary Language Questionnaire
Parent self-reported language
Measured: 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.
Measured: Baseline 1 time data at the time of enrollment
Health Literacy - Flesch Kincaid Reading Level
Consent form grade reading level
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: discharge data - 1 time data at the time of PICU discharge, expected up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start13 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Recruitment delayed during COVID as primary study halted recruitment. Following this, intervention (informational video) was being utilized outside of protocol intervention (informational video)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Paquette, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Erin Paquette, MD, JD, MBe, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953169
- Sponsor's protocol ID
- 2017-1092
- Status last verified
- Nov 2024
- First submitted
- 2 Jul 2020
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once we reach target enrollment, we will analyze the data, and prepare a manuscript for publication and grants; the time frame will be approximately Jan 2022 - June 2022.
Publications
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.
PubMed 23345569McGregor 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.
PubMed 23281421Federal Policy for the Protection of Human Subjects. 45 CFR 46. September 8, 2015 2015;80(173):53933-54061.
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.
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.
PubMed 26692497BRIEF Health Literacy Screen: https://healthliteracy.bu.edu/brief
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.
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
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.
PubMed 12437405
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Health Literacy in Biorepository Consents
- ClinicalTrials.gov ID
- NCT04953169
- Acronym / sponsor ID
- 2017-1092
- Conditions
- Pediatric, Critical Illness, Consent
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment delayed during COVID as primary study halted recruitment. Following this, intervention (informational video) was being utilized outside of protocol intervention (informational video)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video | Other | Other: Biobank VideoThe video is information regarding biobanking |
| Non-Video | Other | Other: Non-VideoThe non-video group will receive a written informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents of patients who are nearing readiness for discharge/clinically stable to participate
Key exclusion criteria (1 listed)
- Other Languages Except For English and Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobank VideoThe video describes the process of biobanking with visuals | Other | Video |
| Non-VideoThe non-video group will receive a written informed consent | Other | Non-Video |
Primary outcome
Rates of enrollment into a biorepository based on consent type
Time frame: 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
21 secondary outcomes
Parent Race Questionnaire
Time frame: Baseline 1 time data at time of enrollment
Child Race Chart Extraction
Time frame: Baseline 1 time data at time of enrollment
Parent Ethnicity Questionnaire
Time frame: Baseline 1 time data at time of enrollment
Child Ethnicity Chart Extraction
Time frame: Baseline 1 time data at time of enrollment
Parent age Questionnaire
Time frame: Baseline 1 time data at time of enrollment
Child age Chart Extraction
Time frame: Baseline 1 time data at time of enrollment
Child gender Chart Extraction
Time frame: Baseline 1 time data at time of enrollment
Parent gender Questionnaire
Time frame: Baseline 1 time data at time of enrollment
Parent Education Level Questionnaire
Time frame: Baseline 1 time data at time of enrollment
Parent Primary Language Questionnaire
Time frame: Baseline 1 time data at time of enrollment
Health Literacy - Parent Self Report on BRIEF Questionnaire
Time frame: Baseline 1 time data at the time of enrollment
Health Literacy - Flesch Kincaid Reading Level
Time frame: Baseline 1 time data at the time of enrollment
Knowledge about biobanking Questionnaire - Semi Structured Comprehension Interview
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
Time frame: Baseline 1 time data at the time of enrollment
Satisfaction with understandability Questionnaire - PEMAT-AV for video recipients
Time frame: Baseline 1 time data at the time of enrollment
Satisfaction with understandability Questionnaire - PEMAT-Print for standard consent recipients
Time frame: Baseline 1 time data at the time of enrollment
What motivated participation - most important factor from Parent Questionnaire
Time frame: Baseline 1 time data at the time of enrollment
What motivated participation - factors that played a role from parent questionnaire
Time frame: Baseline 1 time data at the time of enrollment
Parental Anxiety Questionnaire Abbreviated Parental Stress Scale: PICU (A-PSS PICU):
Time frame: Baseline 1 time data at the time of enrollment.
Parental Trust in the Health System/Research Questionnaire
Time frame: baseline 1 time data at the time of enrollment
Satisfaction with decision regarding biorepository enrollment Questionnaire - Decision Regret Scale
Time frame: discharge data - 1 time data at the time of PICU discharge, expected up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 23345569Menon 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.
- Background: PubMed 23281421McGregor 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.
- BackgroundFederal Policy for the Protection of Human Subjects. 45 CFR 46. September 8, 2015 2015;80(173):53933-54061.
- BackgroundCarman 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.
- Background: PubMed 26692497Rodriguez-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.
- BackgroundBRIEF Health Literacy Screen: https://healthliteracy.bu.edu/brief
- BackgroundChild 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.
- BackgroundPEMAT AV: https://www.ahrq.gov/ncepcr/tools/self-mgmt/pemat-av.html
- BackgroundPEMAT PRINT: https://www.ahrq.gov/ncepcr/tools/self-mgmt/pemat-p.html
- Background: PubMed 12437405Corbie-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.
- Individual participant dataSharing planned: No. Once we reach target enrollment, we will analyze the data, and prepare a manuscript for publication and grants; the time frame will be approximately Jan 2022 - June 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Paquette, MD, JD, MBe principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobank Video and Non-Video in people with Pediatric and Critical Illness, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of enrollment into a biorepository based on consent type (time frame: Admission to Discharge from PICU (anticipated up to 6 months but will vary by participant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953169, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.