Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
Boston Children's Hospital · with Agency for Healthcare Research and Quality (AHRQ), Pediatric Research in Inpatient Settings (PRIS) · NCT05407129
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Any age listed · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 656
- US sites recruiting
- 1
- Study start
- April 13, 2023
- Record last updated
- March 24, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Family safety reporting intervention
Conditions: Family Reported Errors and Adverse Events; Health Disparities; Family Safety Reporting; Patient Safety; Voluntary Incident Reporting; Quality Improvement
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Patient/Family/Caregiver who has been hospitalized on the study unit during the study period (within the past 24 hours) or hospital employee who works at the study sites
- Participants speaking all languages are eligible
Exclusion Criteria
- Admitted awaiting inpatient psychiatric placement
- In state custody
- Admitted for greater than 24 hours
- Same day discharge
- Covid positive
- Previously enrolled in I-SHARE
- Airborne illness precautions
Recruiting US locations
Boston Children's Hospital
Boston, MA 02115
Site contact: Alisa Khan, MD, MPH · 617-355-2565 · alisa.khan@childrens.harvard.edu
Study contacts (from the official record)
- Alisa Khan, MD, MPH · 6173552565 · alisa.khan@childrens.harvard.edu
- Monica Soni, BA · 8572183233 · monica.soni@childrens.harvard.edu
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