Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05407129

Conditions

Family Reported Errors and Adverse Events

Health Disparities

Family Safety Reporting

Patient Safety

Voluntary Incident Reporting

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Family safety reporting intervention

Study Details

Brief 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.

Conditions

Family Reported Errors and Adverse Events

Health Disparities

Family Safety Reporting

Patient Safety

Voluntary Incident Reporting

Study ID

NCT05407129

Start date

Apr 13, 2023

Status verified date

Mar, 2026

Completion date

Oct 28, 2028

Anticipated

Primary completion date

Oct 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

656 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual care

This arm is the usual care arm of parents and providers who are randomized to proceed with usual care and are not given the family safety reporting intervention.

experimental: Experimental: Intervention arm

This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units.

Interventions

Family safety reporting intervention

Family safety reporting intervention for patients/families

Primary outcome measure

  • Medical errors [ Time Frame: From date of randomization through hospital discharge (typically about 7 days). ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Alisa Khan, MD, MPH

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-24.