Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)

Boston Children's Hospital

Status: Enrolling

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

Treatments: Behavioral: Family safety reporting intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05407129

IRB-P00042333

Details and patient eligibility

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.

Full description

After piloting the intervention in one inpatient unit, marked improvements in family safety reporting and reductions in disparities in reporting by parent education and language results. The investigators now propose to conduct an RCT of the intervention in 4 geographically, ethnically, and linguistically diverse hospitals. The specific aims are to: (1) evaluate the effectiveness of the intervention in improving error detection and other safety outcomes, (2) assess the impact of the intervention on disparities in reporting, and (3) understand contextual factors contributing to successful implementation of the intervention. If effective, the intervention will contribute by: (1) increasing patient/family engagement in reporting, especially from vulnerable groups, (2) identifying otherwise unrecognized events, and (3) enabling hospitals to better understand safety problems in a 360-degree manner and design more effective, patient-centered solutions. Our application has high potential to reshape paradigms for measuring and improving safety and equity.

Hypothesis 1A: The I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).

Hypothesis 1B: In the I-SHARE arm, rates of errors detected by the I-SHARE tool will exceed rates detected through VIR.

Hypothesis 1C: The I-SHARE arm will have higher safety experience, safety climate, and patient activation scores than usual care.

Hypothesis 2A: Among Spanish-speaking and less educated patients/families, the I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).

Hypothesis 2B: In the I-SHARE arm, Spanish-speaking and less educated patients/families will report equal rates of errors as English-speaking and more educated patients/families (via I-SHARE tool).

Enrollment: 656 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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656 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: Family safety reporting intervention