Current Environment:


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 Spanish and English 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. After piloting the intervention in one inpatient unit, marked improvements in family safety reporting and reductions in disparities in reporting by parent education and language results. The investigators now propose to conduct an RCT of the intervention in 4 geographically, ethnically, and linguistically diverse hospitals. The specific aims are to: (1) evaluate the effectiveness of the intervention in improving error detection and other safety outcomes, (2) assess the impact of the intervention on disparities in reporting, and (3) understand contextual factors contributing to successful implementation of the intervention. If effective, the intervention will contribute by: (1) increasing patient/family engagement in reporting, especially from vulnerable groups, (2) identifying otherwise unrecognized events, and (3) enabling hospitals to better understand safety problems in a 360-degree manner and design more effective, patient-centered solutions.


Family Reported Errors and Adverse Events, Health Disparities, Family Safety Reporting, Patient Safety, Voluntary Incident Reporting, Quality Improvement

Recruitment Status


Eligibility Criteria

Inclusion Criteria:

Patient/Family/Caregiver who is hospitalized on the study unit during the study period or hospital employee who works at the study sites
Primarily English- or Spanish-speaking (other languages pending interpreter/translator resources)

Exclusion Criteria:

Admitted awaiting inpatient psychiatric placement
In state custody


Intervention Type

Intervention Name


Family safety reporting intervention


Not Applicable



Min Age


Max Age


Download Date

February 20, 2024

Principal Investigator

Alisa Khan

This field has been modified from to show a contact specific to Boston Children's.

Primary Contact Information

Tiffany T Ngo, MA

This field has been modified from to show a contact specific to Boston Children's.

For more information on this trial, visit


For more information and to contact the study team:

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences NCT05407129 Tiffany T Ngo, MA