Sponsor study identifier
observational
552
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 2013
Actual (reported)August 2013
Actual (reported)July 18, 2014
Actual (reported)July 22, 2014
Actual (reported)Disclosure rates for social needs questions
The difference in disclosure rates will be determined by comparing the two arms and determining significant differences for social needs variables.
At time point 1, when the subject is first assessed
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.
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.
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).
Children's Hospital Oakland
Oakland, California, 94618, United States
Gottlieb L, Hessler D, Long D, Amaya A, Adler N. A randomized trial on screening for social determinants of health: the iScreen study. Pediatrics. 2014 Dec;134(6):e1611-8. doi: 10.1542/peds.2014-1439. Epub 2014 Nov 3.
Laura M Gottlieb, MD, MPH
University of California, San Francisco
552 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2014
First Posted
July 22, 2014
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
July 22, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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