Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT05407129

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Led by Boston Children's Hospital · Updated on 2026-03-24

656

Participants Needed

1

Research Sites

289 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

A

Agency for Healthcare Research and Quality (AHRQ)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient, family member, or caregiver hospitalized on the study unit within the past 24 hours
  • Hospital employees who work at the study sites
  • Participants speaking all languages are eligible
Not Eligible

You will not qualify if you...

  • Admitted awaiting inpatient psychiatric placement
  • In state custody
  • Hospitalized for more than 24 hours
  • Same day discharge
  • Covid positive
  • Previously enrolled in I-SHARE
  • Under airborne illness precautions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

A

Alisa Khan, MD, MPH

CONTACT

M

Monica Soni, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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