Clinical trial NCT05407129: Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
Official title: Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Reported Errors and Adverse Events
Health Disparities
Family Safety Reporting
Patient Safety
Voluntary Incident Reporting
Quality Improvement
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Pediatric Research in Inpatient Settings (PRIS)
First posted: 2022-06-07
Enrollment: 656
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Medical errors
timeFrame: From date of randomization through hospital discharge (typically about 7 days).
Secondary outcomes:
measure: Hospital experience
timeFrame: From date of randomization through hospital discharge (typically about 7 days).
measure: Hospital safety climate
timeFrame: From date of randomization through hospital discharge (typically about 7 days).
measure: Patient/parent patient activation
timeFrame: From date of randomization through hospital discharge (typically about 7 days).
measure: Patient/family reported safety concerns concerns
timeFrame: From date of randomization through hospital discharge (typically about 7 days).
Other outcomes:
measure: Patient/family-reported areas for safety improvement
timeFrame: From date of randomization through hospital discharge (typically about 7 days).
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital/Harvard Medical School
name: Alisa Khan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: