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RECRUITING
NCT05407129
NA

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

656

Start Date

2023-04-13

Completion Date

2028-10-28

Last Updated

2026-03-24

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Family safety reporting intervention

Family safety reporting intervention for patients/families

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States