Inpatient Experience Survey AdministrationFIQS DINCT07871136
FIQS Dissemination and Implementation
A study testing Text-Only Enrollment Strategy, Text Plus In-Person Enrollment Strategy and Anonymous Safety Reporting with Impact Website in people with Inpatient Experience Survey Administration and Inpatient Experience Survey Response, run by University of California, San Francisco at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Inpatient Experience Survey Administration, Inpatient Experience Survey Response, Inpatient Pediatric Care
- What is being tested?
- Text-Only Enrollment Strategy, Text Plus In-Person Enrollment Strategy and Anonymous Safety Reporting with Impact Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,800 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Oct 2026to 31 Dec 2029
- Phase
- Interventional
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Patient or parent/guardian present during hospitalization
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Texas Children's Hospital North Austin Campus
Austin, Texas, 78717
Veena Ramgopal, MD, 832-824-5447, vxramgop@texaschildrens.org
Joyee Vanchani, MD, 832-824-5447, jgvachan@bcm.edu
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Audrey Kamzan, MD, 310-825-9111, aKamzan@mednet.ucla.edu
UCSF Benioff Children's Hospital - Oakland
Oakland, California, 94609
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
Matthew Schefft, DO, MSHA, 804-828-9602, matthew.schefft@vcuhealth.org
UC Davis Children's Hospital
Sacramento, California, 95817
Jennifer Rosenthal, MD, MAS, 916-734-2011, rosenthal@ucdsvis.edu
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, 94158
Glenn Rosenbluth, MD, 415-476-9180, glenn.rosenbluth@ucsf.edu
Naomi Bardach, MD, MAS in Clinical Research, 415-476-9188, Naomi.Bardach@ucsf.edu
Seattle Children's Hospital
Seattle, Washington, 98105
Corrie McDaniel, DO, 206-685-2775, Corrie.McDaniel@seattlechildrens.org
Texas Children's Hospital The Woodlands Inpatient and Emergency
The Woodlands, Texas, 77384
Veena Ramgopal, MD, 832-824-5447, vxramgop@texaschildrens.org
Joyee Vanchani, MD, 832-824-5447, jgvachan@bcm.edu
About this study
Official title: Family Input for Quality and Safety Dissemination and Implementation
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:
- 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?
- 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?
- What barriers and supports help hospitals successfully use the reports from the survey to make safety improvements without extensive/dedicated research infrastructure?
Read more
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
- Conditions
- Inpatient Experience Survey Administration, Inpatient Experience Survey Response, Inpatient Pediatric Care, Inpatient Pediatric Engagement and Shared Decision-Making
- Being tested
- Text-Only Enrollment Strategy, Text Plus In-Person Enrollment Strategy, Anonymous Safety Reporting with Impact Website, Identified Safety Reporting, Safety Reporting Integration Toolkit
- Keywords
- Family-centered safety surveillance, Pediatric hospital quality improvement, Patient engagement technology, Pediatric patient safety, Pediatric inpatient quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-Only Enrollment StrategyBehavioural
Automated 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 StrategyBehavioural
Automated 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 WebsiteBehavioural
Mobile 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 ReportingBehavioural
Mobile 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 ToolkitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Text-Only Enrollment | Active comparator | 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 Receives: Behavioral: Text-Only Enrollment Strategy |
| Aim 1: Text Plus In-Person Enrollment | Active comparator | 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. Receives: Behavioral: Text Plus In-Person Enrollment Strategy |
| Aim 2: Default Anonymous Reporting with Website about Impact of Program | Active comparator | 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. Receives: Behavioral: Anonymous Safety Reporting with Impact Website |
| Aim 2: Identified Reporting without Impact information | Active comparator | 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. Receives: Behavioral: Identified Safety Reporting |
| Aim 3: All site toolkit implementation | Other | 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. Receives: Other: Safety Reporting Integration Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Enrollment Opt-Out Rate
Proportion of eligible participants who opt-out of safety reporting participation by enrollment strategy
Measured: 9 months
Aim 2: Safety Reporting Rate
Number of safety reports submitted per 100 patient-days by reporting strategy
Measured: 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.
Measured: 18 months
Secondary outcomes (5)
Aim 1: Enrollment Opt-Out Rate by Demographics
Opt-out rates analyzed by participant race, ethnicity, and language preferences
Measured: 9 months
Aim 2: Reporting Rate by Demographics
Safety reporting rates analyzed by participant race, ethnicity, and language preferences
Measured: 9 months
All aims: Safety Report Content Categories
Distribution of safety report topics and categories by study arm
Measured: 36 months
Aim 3: Safety Interventions Implemented
Number and types of system-level safety interventions undertaken and completed in response to safety reports
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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 Inpatient Experience Survey AdministrationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study uses a sequential parallel design across three aims conducted over different time periods. Aim 1 employs cluster randomization at the hospital unit level (units randomized to one of the two enrollment strategies) and takes place over 9 months. Aim 2 uses individual participant randomization (1:1 allocation to anonymous vs. identified reporting strategies) and takes place over the subsequent 9 months. Aim 3 is a single-arm implementation study where all participating units receive the toolkit intervention over the subsequent 18 month. Participants in Aims 1 and 2 are enrolled from sequential time periods, while Aim 3 participants may include both previous participants and new enrollees based on inpatient admissions during an 18-month implementation phase.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Seattle Children's Hospital, Virginia Commonwealth University, University of California, Los Angeles, University of California, Davis, Baylor College of Medicine, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Naomi Bardach, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871136
- Sponsor's protocol ID
- 25-44346 FIQS DI
- Other IDs
- 1R01HD119441-01
- Acronym
- FIQS DI
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bardach NS, Stotts JR, Fiore DM, Sarkar U, Sharma AE, Boscardin WJ, Avina L, Peralta-Neel C, Rosenbluth G. Family Input for Quality and Safety (FIQS): Using mobile technology for in-hospital reporting from families and patients. J Hosp Med. 2022 Jun;17(6):456-465. doi: 10.1002/jhm.2777. Epub 2022 Feb 4.
PubMed 35535946