Safety Reporting Strategies for Hospitalized Children
(FIQS DI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Naomi Bardach, MD, MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for families of children and adolescent patients who are currently hospitalized in participating children's hospitals. Participants must have access to a mobile phone to receive text messages during their hospital stay.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Anonymous Safety Reporting with Impact Website
- Identified Safety Reporting
- Text-Only Enrollment Strategy
- Text Plus In-Person Enrollment Strategy
Trial Overview
The study is testing different ways to invite families to use a mobile survey tool (text-only vs. text plus brief in-person orientation) and whether reporting safety concerns anonymously or with patient details affects participation and hospital response. Hospitals will also test tools for integrating these reports into quality improvement.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Active Control
Participating hospital units receive a toolkit with lessons learned from earlier collaborative safety improvement efforts and participate in a one-hour coaching session to learn how to integrate Family Input for Quality and Safety (FIQS) reports into their existing quality improvement workflows. Units choose their preferred enrollment method (text-only or text plus in-person orientation) and reporting approach (anonymous or identified) based on findings from earlier study phases. Family members of hospitalized children and adolescent patients (\>12 y.o.) use the FIQS mobile responsive safety reporting tool for 18 months while hospital teams implement toolkit recommendations to review FIQS reports, identify system-level problems, and develop safety interventions. This arm evaluates barriers and facilitators to successfully incorporating patient and family safety observations into hospital safety efforts without extensive, dedicated research infrastructure.
Family members of hospitalized children and adolescent patients (\>12y.o.) receive automated text message invitations to participate in Family Input for Quality and Safety (FIQS) reporting when admitted to participating inpatient study units. The text message includes an opt-out option and a prompt to receive a link by text to an online brochure explaining the FIQS study. No in-person orientation or interaction with hospital staff is provided regarding study enrollment. Enrolled participants receive daily text messages prompting them to report safety observations through the mobile-responsive FIQS survey. This arm tests whether a streamlined, text-only enrollment approach can effectively engage families and adolescent patients in safety reporting without requiring hospital staff time for recruitment
Family members of hospitalized children and adolescent patients (\>12 y.o) receive automated text message invitations to participate in Family Input for Quality and Safety (FIQS) reporting when admitted to participating study units, plus a brief in-person orientation from hospital staff (nurses or registration team members). The text message includes an opt-out option and a prompt to receive a link by text to an online brochure explaining the FIQS study. During the admission process, hospital staff provide a standardized verbal explanation of the FIQS study using a physical brochure. Enrolled participants receive daily text messages prompting them to report safety observations through the mobile-responsive FIQS survey. This arm tests whether adding brief in-person orientation by hospital staff (with a physical brochure) improves engagement in safety reporting compared to text-only enrollment.
In a 1:1 randomized design, family members of hospitalized children and adolescent patients (\>12 y.o.) participate in Family Input for Quality and Safety (FIQS) reporting, randomized to this arm, in which their reports are shared with participating hospital units without identifiers (unless they voluntarily provide contact information). For these participants, the FIQS survey tool will link to a website showing how FIQS reports have led to hospital safety improvements. Summary reports to unit leadership are anonymized unless participants choose to provide contact information for follow-up. If contact information is provided, reports are sent immediately to unit leaders for potential service recovery. This arm tests whether maintaining participant anonymity while providing information about program impact encourages ongoing engagement with safety reporting.
In a 1:1 randomized design, family members of hospitalized children and adolescent patients (\>12 y.o) participate in safety reporting where all reports are automatically shared with participating hospital units with identifiers, allowing for direct follow-up and service recovery. Participants in this arm are not directed to receive information about the impact of the FIQS program through the website or as part of the FIQS survey. All reports are sent to site investigators and safety teams with medical record numbers for potential immediate response and service recovery. This arm tests whether making reports identifiable to hospital staff increases actionability and service recovery opportunities, and how reporting without an option to remain anonymous affects participant willingness to engage in reporting safety concerns.
Find a Clinic Near You
Who Is Running the Clinical Trial?
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
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