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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 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.

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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.

Interventions

  • BEHAVIORAL Family safety reporting intervention

Study Locations (1)

Massachusetts

  • Boston Children's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 656 participants
Start Date 2023-04-13
Est. Completion 2028-10-28
Phase NA

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT05407129

The ClinicalTrials.gov registry entry for NCT05407129 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 656 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,263-participant average among 7 other Quality Improvement trials with a reported enrollment target (48% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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