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Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

NCT05407129 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2026-03-24

No results posted yet for this study

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
  • Quality Improvement

Interventions

BEHAVIORAL

Family safety reporting intervention

Family safety reporting intervention for patients/families

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Pediatric Research in Inpatient Settings (PRIS)

    collaborator UNKNOWN

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Alisa Khan, MD, MPH · Boston Children's Hospital/Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2027-10-28
Completion
2028-10-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407129 on ClinicalTrials.gov