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NCT05407129 · ClinicalTrials.gov registry record · NA
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
A NA study of Quality Improvement and Patient Safety, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 656
- Enrollment target
- 1
- Study location
NCT05407129: Recruiting NA study of Quality Improvement and Patient Safety, sponsored by Boston Children's Hospital.
NCT05407129 is a NA study of Quality Improvement and Patient Safety that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 656 participants, below the 1,263-participant average among 7 other Quality Improvement trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05407129, a NA study of Quality Improvement and Patient Safety, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 656 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Investigators will evaluate rates and types of errors detected through the mobile tool and through voluntary incident reporting (VIR). Errors will be validated by physician and chart review in real time using an established process the study team has used in prior studies.
Conditions Studied
Interventions
- BEHAVIORAL Family safety reporting intervention
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 656 participants |
| Start Date | 2023-04-13 |
| Est. Completion | 2028-10-28 |
| Phase | NA |
What NCT05407129 shows while recruiting
NCT05407129 is an interventional study that assigns participants to a tested intervention. The registered 656 participants enrollment target is mid-sized for trials with a published cap, below the 1,263-participant average among 7 other Quality Improvement trials with a reported enrollment target (48% lower).
The record links to 6 conditions, with Quality Improvement appearing as the primary indexed condition, and to 1 intervention - of which Family safety reporting intervention is the first listed.
NCT05407129 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05407129 about?
NCT05407129 is a clinical study titled "Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences". 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...
What is the current status of trial NCT05407129?
This trial is currently recruiting. It is a NA study. The enrollment target is 656 participants. The study started on 2023-04-13. Estimated completion is 2028-10-28.
What conditions does trial NCT05407129 study?
This clinical trial studies the following conditions: Quality Improvement, Patient Safety, Health Disparities, Family Reported Errors and Adverse Events, Family Safety Reporting.
What interventions are being tested in trial NCT05407129?
The interventions under investigation include: Family safety reporting intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05407129?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05407129 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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