Actively Recruiting
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)
Led by Boston Children's Hospital · Updated on 2026-03-24
656
Participants Needed
1
Research Sites
52 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 often rely on voluntary incident reporting by clinical staff to examine safety, but this captures only a small fraction of events and misses many errors, especially among vulnerable groups like patients with language barriers. Patients and families are attentive partners in care who can identify safety issues that go unreported. To improve hospital safety, researchers are studying a new communication intervention designed with families, nurses, physicians, and hospital leaders to better engage families in reporting safety concerns. The intervention includes three parts: a multilingual mobile reporting tool that prompts families to share safety concerns via email, text, or QR code; education for families and staff; and a process for sharing family reports with the hospital to address systemic issues. This approach is being tested in a randomized controlled trial across four diverse hospitals, comparing the new intervention to usual care without the family reporting tool. Participants include patients, families, caregivers, and hospital employees on study units. Researchers will collect data on medical errors, hospital experience, safety climate, patient activation, and family-reported safety concerns during hospital stays, typically about seven days. The trial aims to assess the intervention's effectiveness in improving error detection, reducing disparities in reporting, and understanding factors that support successful use. Study participation includes regular safety assessments and monitoring from randomization through hospital discharge.
CONDITIONS
Brief Title
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient, family, or caregiver hospitalized on the study unit within the past 24 hours
- Hospital employee who works at the study sites
- Participants speaking any language are eligible
You will not qualify if you...
- Admitted awaiting inpatient psychiatric placement
- In state custody
- Admitted 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From date of randomization through hospital discharge (typically about 7 days)
Participants receive either the family safety reporting intervention or usual care during their hospitalization to improve safety reporting and outcomes.
During hospital stay, daily participation as patients/families interact with the intervention or usual care
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Alisa Khan, MD, MPH
M
Monica Soni, BA
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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