iScreen Study: Best Methods for Social Screening in Pediatric Caregivers

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02197052

Collaborator

UCSF Benioff Children's Hospital Oakland (Other)

552

Enrollment

Location

Duration (Months)

275.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Disclosure Rates of Social Needs

Study Design

Study Type:

Observational

Actual Enrollment :

552 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

iScreen Study: Best Methods for Social Screening in Pediatric Caregivers

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Disclosure rates for social needs questions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Oakland	Oakland	California	United States	94618

Sponsors and Collaborators

University of California, San Francisco
UCSF Benioff Children's Hospital Oakland

Investigators

Principal Investigator: Laura M Gottlieb, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT02197052

Other Study ID Numbers:

13-11032

First Posted:

Jul 22, 2014

Last Update Posted:

Jul 22, 2014

Last Verified:

Jul 1, 2014

Study Results

No Results Posted as of Jul 22, 2014