An interventional study of Text-Only Enrollment Strategy and Text Plus In-Person Enrollment Strategy in Inpatient Experience Survey Administration, Inpatient Experience Survey Response and Inpatient Pediatric Care, sponsored by University of California, San Francisco. Not yet recruiting at 8 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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:
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:
University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
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Exclusion Criteria:
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
Behavioral: Text-Only Enrollment Strategy
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.
Behavioral: Text Plus In-Person Enrollment Strategy
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.
Behavioral: Anonymous Safety Reporting with Impact Website
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.
Behavioral: Identified Safety Reporting
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.
Other: Safety Reporting Integration Toolkit
Automated text message invitation system for safety reporting participation with online educational materials but no in-person staff interaction during enrollment process.
Automated text message invitation system combined with brief standardized verbal orientation provided by hospital staff during admission process using physical educational brochures.
Mobile safety reporting system where reports are shared without participant identifiers, combined with access to website showing safety improvement examples to encourage continued engagement.
Mobile safety reporting system where all reports are shared with hospital staff including participant identifiers to enable direct follow-up and service recovery.
Implementation 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
Time frame: 9 months
Aim 2: Safety Reporting Rate
Number of safety reports submitted per 100 patient-days by reporting strategy
Time frame: 9 months
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.
Time frame: 18 months
Aim 1: Enrollment Opt-Out Rate by Demographics
Opt-out rates analyzed by participant race, ethnicity, and language preferences
Time frame: 9 months
Aim 2: Reporting Rate by Demographics
Safety reporting rates analyzed by participant race, ethnicity, and language preferences
Time frame: 9 months
All aims: Safety Report Content Categories
Distribution of safety report topics and categories by study arm
Time frame: 36 months
Aim 3: Safety Interventions Implemented
Number and types of system-level safety interventions undertaken and completed in response to safety reports
Time frame: 18 months
Aim 3: Implementation Barriers and Facilitators
Qualitative assessment of barriers and facilitators to successful integration of family safety reports into hospital safety efforts
Time frame: 18 months
Plan to share: Yes — Cleaned, de-identified interview and meeting transcripts will be saved and shared. These data will be collected after obtaining informed consent. They will be shared after de-identification with relevant publications or will be posted in the repository by the end of the project period. Consent forms will include a statement that after deidentification, participant-level data will be shared and can be used for future research. Video recordings, patient-level datasets, and Epic electronic health record (EHR) code and variable names will not be shared, to protect the privacy of patients and research participants.
Supporting information: Study protocol, Informed consent form
Time frame: To facilitate interpretation of the data, data collection instruments, interview guides, and any data dictionaries created will be shared and associated with the relevant datasets. Data will be stored in common and open formats, such as Word files for our audio transcript data, and CSV files for survey data. Information needed to make use of this data along with references to the sources of those standardized names and metadata items will be included wherever applicable. Data will be available after cleaning and analysis. We anticipate a start date of Jan 1, 2030. It will be available for 5 years.
Access criteria: All dataset(s) that can be shared will be deposited in Mendeley, a generalist repository on the list of suggested generalist repositories from the NIH, listed here: https://www.nlm.nih.gov/NIHbmic/generalist_repositories.html As suggested, we will also work with journals to provide the datasets that can be shared as an online appendix for any published journal article using the data. The Mendeley repository provides metadata, persistent DOI identifiers, and long-term access. Mendeley assigns DOIs as persistent identifiers, and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. We will provide the DOI in published papers and reports, in addition to progress reports to the NIH. We will keep our ORCID Records up to date with DOIs for our datasets and publications, ROR, and funder IDs to increase findability.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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