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Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)

Who can join

All ages · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Patient/Family/Caregiver who has been hospitalized on the study unit during the study period (within the past 24 hours) or hospital employee who works at the study sites
* Participants speaking all languages are eligible

Exclusion Criteria:

* Admitted awaiting inpatient psychiatric placement
* In state custody
* Admitted for greater than 24 hours
* Same day discharge
* Covid positive
* Previously enrolled in I-SHARE
* Airborne illness precautions

About the 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.

What is being tested

• Family safety reporting intervention (behavioral)

Sponsor: Boston Children's Hospital · Participants: 656 · Started: Apr 13, 2023

Contact the study team

• Alisa Khan, MD, MPH · Phone: 6173552565
• Monica Soni, BA · Phone: 8572183233

Official record on ClinicalTrials.gov — NCT05407129

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.