Disclosure Rates of Social NeedsNCT02197052
iScreen Study: Best Methods for Social Screening in Pediatric Caregivers
An observational study of Disclosure Rates of Social Needs, run by University of California, San Francisco at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disclosure Rates of Social Needs
- Type of treatment
- Pill or oral medicine
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2013
- Phase
- Observational
- 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
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).
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Oakland
Oakland, California, 94618
About this study
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.
- Conditions
- Disclosure Rates of Social Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time point 1, when the subject is first assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disclosure Rates of Social NeedsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- UCSF Benioff Children's Hospital Oakland
- Responsible party
- Sponsor
- Investigators
- Laura M Gottlieb, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197052
- Sponsor's protocol ID
- 13-11032
- Status last verified
- Jul 2014
- First submitted
- 18 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25367545
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iScreen Study: Best Methods for Social Screening in Pediatric Caregivers
- ClinicalTrials.gov ID
- NCT02197052
- Acronym / sponsor ID
- 13-11032
- Conditions
- Disclosure Rates of Social Needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- UCSF Benioff Children's Hospital Oakland
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Jul 2014 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disclosure rates for social needs questions
Time frame: At time point 1, when the subject is first assessed
The difference in disclosure rates will be determined by comparing the two arms and determining significant differences for social needs variables.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Derived from this study: PubMed 25367545Gottlieb 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.
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.
Laura M Gottlieb, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disclosure Rates of Social Needs, run by University of California, San Francisco 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 3 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: finished, as of the sponsor's last update on 22 Jul 2014. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disclosure rates for social needs questions (time frame: At time point 1, when the subject is first assessed). 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 NCT02197052, which also lists 1 linked publication.
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 22 Jul 2014; AzTrials last refreshed its copy on 1 Nov 2026.