Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

NCT05407129 | Recruiting

• 1 other identifier: IRB-P00042333
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Medical errors

  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.

  From date of randomization through hospital discharge (typically about 7 days).

Secondary Outcomes (4)

• Hospital experience

  From date of randomization through hospital discharge (typically about 7 days).

• Hospital safety climate

  From date of randomization through hospital discharge (typically about 7 days).

• Patient/parent patient activation

  From date of randomization through hospital discharge (typically about 7 days).

• Patient/family reported safety concerns concerns

  From date of randomization through hospital discharge (typically about 7 days).

Other Outcomes (1)

• Patient/family-reported areas for safety improvement

  From date of randomization through hospital discharge (typically about 7 days).

Study Arms (2)

Usual care

NO 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.

Experimental: Intervention arm

EXPERIMENTAL

This arm is the intervention arm of parents and providers who are randomized to the family safety reporting intervention on the study units.

Behavioral: Family safety reporting intervention

Interventions

Family safety reporting intervention BEHAVIORAL

Family safety reporting intervention for patients/families

Experimental: Intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Pediatric Research in Inpatient Settings (PRIS): collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Alisa Khan, MD, MPH

  Boston Children's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisa Khan, MD, MPH

CONTACT

6173552565; alisa.khan@childrens.harvard.edu

Monica Soni, BA

CONTACT

8572183233; monica.soni@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hospitalist/Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: April 13, 2023
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)