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Family Safety Reporting for Patient Safety (I-SHARE Trial)
N/A
Recruiting
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
Must not have
Admitted awaiting inpatient psychiatric placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization through hospital discharge (typically about 7 days).
Awards & highlights
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am waiting for a hospital stay for mental health care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization through hospital discharge (typically about 7 days).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization through hospital discharge (typically about 7 days).
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 moreOther outcome measures
Patient/family-reported areas for safety improvement
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Family safety reporting intervention
2018
N/A
~990
Find a Location
Who is running the clinical trial?
Pediatric Research in Inpatient Settings (PRIS)UNKNOWN
Boston Children's HospitalLead Sponsor
773 Previous Clinical Trials
5,580,295 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
402 Previous Clinical Trials
6,820,940 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish primarily.I am waiting for a hospital stay for mental health care.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Experimental: Intervention arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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