Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT05407129
Status
Recruiting
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Conditions

  • Family Reported Errors and Adverse Events
  • Family Safety Reporting
  • Health Disparities
  • Patient Safety
  • Quality Improvement
  • Voluntary Incident Reporting

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Family safety reporting intervention — BEHAVIORAL
    Family safety reporting intervention for patients/families

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
Mar 2026
Primary completion
Oct 28, 2027
Completion
Oct 28, 2028

Study Design

Enrollment
656 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual care
    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.
  • Experimental: Experimental: Intervention arm
    This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units.

Primary Outcome Measure

Medical errors [ Time Frame: From date of randomization through hospital discharge (typically about 7 days). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Alisa Khan, MD, MPH
[email protected]
617-355-2565
Alisa Khan, MD, MPH (PRINCIPAL_INVESTIGATOR)
Jennifer Baird, PhD, MPH, RN (SUB_INVESTIGATOR)
Hsiang "Shonna" Yin, MD, MS (SUB_INVESTIGATOR)
Michelle Kelly, MD, MPH (SUB_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MA

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