Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID05407129

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

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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Frequently Asked Questions

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