Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences

Patient Safety Clinical Trial

— I-SHARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407129
• Other study ID #: IRB-P00042333
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2023
• Est. completion date: October 28, 2028

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: Alisa Khan, MD, MPH
• Phone: 6173552565
• Email: alisa.khan[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Spanish and English 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: October 28, 2028
• Est. primary completion date: October 28, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient/Family/Caregiver who is hospitalized on the study unit during the study period or hospital employee who works at the study sites

• Primarily English- or Spanish-speaking (other languages pending interpreter/translator resources)

Exclusion Criteria:

• Admitted awaiting inpatient psychiatric placement

• In state custody

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Family safety reporting intervention
Family safety reporting intervention for patients/families

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Agency for Healthcare Research and Quality (AHRQ), Pediatric Research in Inpatient Settings (PRIS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient/family-reported areas for safety improvement	This qualitative outcome is based on a content analysis of patient/family safety reports to identify themes and areas for improvement in real-time that can be shared with the unit and hospital to improve safety.	From date of randomization through hospital discharge (typically about 7 days).
Primary	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	Hospital experience	Measured through the Child HCAHPS survey administered prior to discharge. This survey assesses the experience of pediatric patients. It is available in English and Spanish. Particular items of interest include the "preventing mistakes and helping you report concerns" composite measure, which was the single-lowest rated item across hospitals during field testing. This survey consists of closed-ended and Likert scale items. It was developed by the Center of Excellence for Pediatric Quality Measurement at Boston Children's Hospital with funding from AHRQ, CMS, and CHIPRA. The "helping you report" item is assessed on a 3-point scale, with response options of "No," "Yes, somewhat," and "Yes, definitely," with "Yes, definitely" being the best option.	From date of randomization through hospital discharge (typically about 7 days).
Secondary	Hospital safety climate	Measured through the Children's Hospital administered prior to hospital discharge Safety Climate Questionnaire (Cox et al. 2013), which contains 14 questions related to parent perceptions of hospital safety climate. Questions were adapted from the AHRQ Hospital Survey on Patient Safety Culture. The survey consists of Likert-scale items and was validated using confirmatory factor analysis. Domains include overall perceptions of safety, staff communication openness, parent communication openness,and handoffs and transitions. This survey is included as a QualityTool in the AHRQ's Health Care Innovations Exchange. Scales range from Strongly Agree to Strongly Disagree (1-5), with Strongly Agree being the best option, except for reverse-coded items, for which Strongly Disagree is the best option.	From date of randomization through hospital discharge (typically about 7 days).
Secondary	Patient/parent patient activation	Measured through the PAM (Patient Activation) administered prior to hospital discharge Measure) and the P-PAM (Parent-Patient Activation Measure) to participants. These surveys measure individuals' knowledge, skills, and confidence ("patient activation") in managing their well-being. The 13-item P-PAM was adapted from the PAM measure and is available in English and Spanish and has acceptable validity and reliability in both English and Spanish. The PAM was developed using qualitative methods, Rasch analysis, and test theory psychometric methods. Items on the measure form a unidimensional, probabilistic, Guttman-like scale. Scales range from Strongly Disagree to Strongly Agree (1-4), with Strongly Agree being the best option.	From date of randomization through hospital discharge (typically about 7 days).
Secondary	Patient/family reported safety concerns concerns	Will use data from the family safety reporting tool to analyze the percentage of enrolled patient/families that report through the tool. This will allow the team to understand uptake and compare patient/safety reporting among Spanish-speakers vs English-speakers and less educated vs more educated participants enrolled in the intervention arm.	From date of randomization through hospital discharge (typically about 7 days).