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Study identifier: NCT05407129 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Condition: Family Reported Errors and Adverse Events · Health Disparities · Family Safety Reporting  ·  Sponsor: Boston Children's Hospital

PhaseNA
Planned participants656
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersYes

About this study

Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include patients and families in safety reporting and instead relying on flawed VIR presents an important missed opportunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital leaders, investigators created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. The intervention includes 3 elements: (1) a multilingual mobile (email, text, and QR-code) reporting tool prompting families to share concerns and suggestions about safety, (2) family/staff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed.

This description comes directly from the study's public registry record.

Talk to the study team

Alisa Khan, MD, MPH  ·  6173552565  ·  alisa.khan@childrens.harvard.edu

Monica Soni, BA  ·  8572183233  ·  monica.soni@childrens.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05407129