- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02197052
iScreen Study: Best Methods for Social Screening in Pediatric Caregivers
July 18, 2014 updated by: University of California, San Francisco
The goal is to better understand the social needs of a population seeking care in a large, urban children's hospital emergency department with a large Medicaid population.
Consenting English and Spanish-speaking adult caregivers will be randomized to social screening via a face -to-face interview with a trained bilingual researcher or via a self-completed tablet-based survey.
We hypothesize that there will be no difference in disclosure rates between the two screening formats for items other than highly sensitive items.
For highly sensitive items we hypothesize disclosure rates will be higher for the self-completed tablet-based survey.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
552
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States, 94618
- Children's Hospital Oakland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants were drawn from adult caregivers seeking treatment for a child in a fast track arm of a large, urban children's hospital emergency department in Oakland, CA (CHO ED Annex).
Description
Inclusion Criteria:
- Caregiver must by age 18 years or older accompanying a child less than 18 years old
- Primary language English or Spanish
- Familiar with the child's household environment
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Computer Based Survey Arm
Participants randomized to the computer based self-completed survey arm were issued a tablet computer to answer survey questions.
All participants were encouraged to ask for technical assistance if needed at any point, and like in the face-to-face interviews, electronic survey could be re-initiated at the point of discontinuation after any interruption.
Those in the tablet survey arm also could complete the survey in their preferred language and all were additionally given headsets so they could use audio assist with identical, pre-recorded questions in the selected language.
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Face-to-face interview arm
Participants randomized to this condition were interviewed in-person by a fully bilingual (English-Spanish), bi-cultural research assistant trained in cultural humility, standard research protocols and interviewing practices.
Interviews were conducted in clinical rooms in respondent's preferred language, were easily interrupted for medical care, and the survey could be re-initiated at the point of discontinuation after any interruption.
Participant responses during face-to-face interviews were recorded by the research assistant on paper and later recorded electronically.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Disclosure rates for social needs questions
Time Frame: At time point 1, when the subject is first assessed
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The difference in disclosure rates will be determined by comparing the two arms and determining significant differences for social needs variables.
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At time point 1, when the subject is first assessed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Laura M Gottlieb, MD, MPH, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
July 18, 2014
First Submitted That Met QC Criteria
July 18, 2014
First Posted (Estimate)
July 22, 2014
Study Record Updates
Last Update Posted (Estimate)
July 22, 2014
Last Update Submitted That Met QC Criteria
July 18, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 13-11032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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