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Family Safety Reporting for Patient Safety (I-SHARE Trial)

Led By Alisa Khan, MD, MPH
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization through hospital discharge (typically about 7 days).
Awards & highlights

I-SHARE Trial Summary

This trial seeks to improve hospital safety by creating a system to engage patients' families in safety reporting. The intervention includes a mobile reporting tool, education for families and staff, and a process for sharing reports with the unit and hospital. The trial will test the intervention in 4 hospitals to see if it improves error detection and other safety outcomes.

Who is the study for?
This trial is for English or Spanish-speaking patients, families, or caregivers with a hospitalized individual on the study unit during the research period. Hospital employees at the study sites can also participate. It excludes those admitted for psychiatric placement and individuals in state custody.Check my eligibility
What is being tested?
The trial tests a family safety reporting intervention designed to improve hospital safety by including patient and family reports of errors and adverse events. The intervention involves a bilingual mobile reporting tool, education, and processes to address systemic issues.See study design
What are the potential side effects?
There are no direct medical side effects as this is not a drug trial; however, participants may experience emotional or psychological impacts from discussing sensitive health-related incidents.

I-SHARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization through hospital discharge (typically about 7 days).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization through hospital discharge (typically about 7 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medical errors
Secondary outcome measures
Hospital experience
Hospital safety climate
Patient/family reported safety concerns concerns
+1 more
Other outcome measures
Patient/family-reported areas for safety improvement

I-SHARE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: Intervention armExperimental Treatment1 Intervention
This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units.
Group II: Usual careActive Control1 Intervention
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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Family safety reporting intervention

Find a Location

Who is running the clinical trial?

Pediatric Research in Inpatient Settings (PRIS)UNKNOWN
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,074 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,692 Total Patients Enrolled

Media Library

Family safety reporting intervention Clinical Trial Eligibility Overview. Trial Name: NCT05407129 — N/A
Family Safety Reporting Research Study Groups: Usual care, Experimental: Intervention arm
Family Safety Reporting Clinical Trial 2023: Family safety reporting intervention Highlights & Side Effects. Trial Name: NCT05407129 — N/A
Family safety reporting intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05407129 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this research endeavor still open?

"The information found on clinicaltrials.gov indicates that this trial is no longer enrolling participants, having been initially posted in October 2022 and most recently updated in June of the same year. Fortunately, there are 19 other trials actively seeking volunteers at present."

Answered by AI
~437 spots leftby Oct 2027