This study is testing Family Input for Quality and Safety (FIQS), a mobile-based survey tool that allows hospitalized children's families and adolescent patients to report safety concerns in real-time by responding to a text message link on their mobile phone. The main questions it aims to answer are:
1. Does the way families are invited to use the safety reporting survey (text-only invitation versus text plus brief in-person orientation) affect how many families participate and report safety concerns? 2. Does sharing safety reports anonymously versus with patient identifiers (for example, the patient name or room number) affect how often families report concerns and how hospitals respond? 3. What barriers and supports help hospitals successfully use the reports from the survey to make safety improvements without extensive/dedicated research infrastructure?
Researchers will compare different enrollment approaches and anonymous versus identified reporting across multiple children's hospitals to see which methods work best for engagement with the FIQS tool. Participants will:
* Receive automated text message invitations when their child is admitted to participating hospital units * Be randomly assigned to receive either text-only invitation or an additional brief in-person orientation * Use a mobile-responsive survey to report safety concerns during their hospital stay through daily text prompts * Be randomly assigned to have their reports shared either anonymously or with identification to help hospital staff follow up * Participate during hospitalization while hospitals learn to integrate family safety reports into their quality improvement efforts
Family members or caregivers of patients (aged 0 to 21 years) admitted to participating hospital units
Patients aged 13 years and older admitted to participating hospital units
English or Spanish speakers
Patient or parent/guardian owns a mobile phone
Patients or parents/guardians who are non-English and non-Spanish speakers
Patients or parents/guardians who do not own a mobile phone
Patients admitted under sensitive services
Patients who are in the foster care system
Sequential
Text-Only Enrollment Strategy
BehavioralAutomated text message invitation system for safety reporting participation with online educational materials but no in-person staff interaction during enrollment process.
Text Plus In-Person Enrollment Strategy
BehavioralAutomated text message invitation system combined with brief standardized verbal orientation provided by hospital staff during admission process using physical educational brochures.
Anonymous Safety Reporting with Impact Website
BehavioralMobile safety reporting system where reports are shared without participant identifiers, combined with access to website showing safety improvement examples to encourage continued engagement.
Identified Safety Reporting
BehavioralMobile safety reporting system where all reports are shared with hospital staff including participant identifiers to enable direct follow-up and service recovery.
Safety Reporting Integration Toolkit
Other interventionImplementation toolkit with lessons learned and one-hour coaching session to help hospital units integrate family safety reports into existing quality improvement workflows without research support.
Aim 1: Enrollment Opt-Out Rate
Proportion of eligible participants who opt-out of safety reporting participation by enrollment strategy
Aim 2: Safety Reporting Rate
Number of safety reports submitted per 100 patient-days by reporting strategy
Aim 3: Workflow Integration Success
Number of hospital units successfully integrating safety report reviews into existing safety workflows, with at least monthly review of FIQS safety reports in existing group safety meetings.
Aim 1: Enrollment Opt-Out Rate by Demographics
Opt-out rates analyzed by participant race, ethnicity, and language preferences
Aim 2: Reporting Rate by Demographics
Safety reporting rates analyzed by participant race, ethnicity, and language preferences
All aims: Safety Report Content Categories
Distribution of safety report topics and categories by study arm
Aim 3: Safety Interventions Implemented
Number and types of system-level safety interventions undertaken and completed in response to safety reports
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Seattle Children's Hospital
Collaborator
Virginia Commonwealth University
Collaborator
University of California, Los Angeles
Collaborator
University of California, Davis
Collaborator
Baylor College of Medicine
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
