Family Safety Reporting for Patient Safety

(I-SHARE Trial)

Overseen By Monica Soni, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Psychiatric placement, State custody, Covid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

656 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve hospital safety by involving families in reporting safety concerns. It focuses on a mobile tool that enables families of hospitalized children to share their safety suggestions and worries. This tool is part of the Family Safety Reporting Intervention, also known as the Family-Initiated Safety Reporting System. Participants will either continue with usual care or use this new reporting tool, along with receiving education on the process. Suitable candidates for this trial include families and caregivers of children hospitalized at the study site within the last 24 hours. Families speaking any language can participate, as the tool is available in multiple languages. As an unphased trial, this study offers families a unique opportunity to actively contribute to enhancing hospital safety practices.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this family safety reporting intervention is safe?

Research shows that the family safety reporting intervention is safe. Studies have found significant improvements in how families report safety issues in hospitals after implementing this intervention. Families are more involved in noticing and reporting problems, enhancing overall patient safety.

No reports of harm or negative effects have emerged from using this approach. In fact, involving families might help identify issues that could otherwise be overlooked. This makes the intervention not only safe but also potentially very helpful in improving hospital safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the family safety reporting intervention because it empowers families to actively participate in ensuring patient safety, a focus not typically emphasized in standard care. Unlike traditional approaches that rely solely on healthcare providers, this intervention encourages collaboration between families and providers, potentially leading to quicker identification and resolution of safety concerns. By integrating family insights into the safety protocol, there is an opportunity to enhance overall care quality and patient outcomes.

What evidence suggests that the Family Safety Reporting Intervention is effective for improving patient safety?

Research has shown that when patients and their families report safety issues, hospital safety can improve significantly. In this trial, some participants will join the intervention arm, using the family safety reporting intervention. Previously tested in one hospital unit, this program demonstrated significant improvements in how families shared concerns. It also helped families overcome language barriers by using a multilingual mobile tool. By involving families and educating both them and the staff, hospitals can better address safety problems. Overall, evidence indicates that this method can enhance patient safety by identifying more issues that might otherwise be missed. ^{2 3 6 7 8}

Who Is on the Research Team?

Alisa Khan, MD, MPH

Principal Investigator

Boston Children's Hospital/Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking patients, families, or caregivers with a hospitalized individual on the study unit during the research period. Hospital employees at the study sites can also participate. It excludes those admitted for psychiatric placement and individuals in state custody.

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

Exclusion Criteria

In state custody

I am waiting for a hospital stay for mental health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the family safety reporting intervention using a multilingual mobile tool, family/staff education, and sharing family reports with the unit and hospital

7 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including error detection and safety climate assessment

7 days

In-hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• Family safety reporting intervention

Trial Overview The trial tests a family safety reporting intervention designed to improve hospital safety by including patient and family reports of errors and adverse events. The intervention involves a bilingual mobile reporting tool, education, and processes to address systemic issues.

How Is the Trial Designed?

Group I: Experimental: Intervention arm Experimental Treatment 1 Intervention

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

Group II: Usual care Active Control 1 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.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Pediatric Research in Inpatient Settings (PRIS)

Collaborator

Trials

1

Recruited

660+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

Simply reporting critical incidents in healthcare does not automatically lead to improved patient safety; significant improvements come from analyzing these incidents and implementing system changes based on the findings.

Involving patients and their families in safety discussions, along with fostering a culture of anonymity and feedback, can enhance the reporting of incidents and ultimately contribute to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical incident monitoring in paediatric and adult critical care: from reporting to improved patient outcomes? Frey, B., Schwappach, D.[2022]

In a study analyzing 82 incident reports from a hospital's reporting system between 2008 and 2010, it was found that nearly half of the adverse events were noticed by patients themselves.

Most of the incidents reported by patients resulted in moderate harm, highlighting the importance of patient involvement in identifying safety issues in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whose Voices are Heard in Patient Safety Incident Reports? Saranto, K., Bates, DW., Mykkänen, M., et al.[2022]

A systematic review of 15 studies highlighted that interventions aimed at engaging patients and their families in safety measures can improve safety perceptions, particularly those focused solely on providing information.

Interventions that combined both information and active involvement showed varied effectiveness, indicating a need for more comprehensive and rigorously designed studies to better understand how to engage patients and families in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Engage Patients and Families in Patient Safety: A Systematic Review. Lee, M., Lee, NJ., Seo, HJ., et al.[2022]

The Critical Incident Reporting System (CIRS) allows healthcare team members to anonymously report errors and complications, which helps identify systemic issues rather than blaming individuals.

By analyzing reported incidents, CIRS aims to improve patient safety through organizational changes and better practices, ultimately reducing harm to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient safety -- mission for the future: The importance of Critical Incident Reporting Systems (CIRS) in clinical practice]. Maas, M., Güß, T.[2014]

In a study involving 989 hospitalized children, family reporting of medical errors and adverse events (AEs) identified 8 previously unrecognized AEs, including 7 that were preventable, highlighting the importance of including family perspectives in safety surveillance.

Error rates were significantly higher when family reporting was utilized (45.9 per 1000 patient-days) compared to when it was not (39.7 per 1000 patient-days), suggesting that families can enhance the detection of safety issues in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Families as Partners in Hospital Error and Adverse Event Surveillance. Khan, A., Coffey, M., Litterer, KP., et al.[2019]

The Family Reporting System (FRS) was developed to allow families of hospitalized children to report adverse events, addressing the limitations of standard clinician-initiated reporting systems that often miss many documented events.

The FRS demonstrated good face validity, excellent usability, and strong clinical utility, indicating it is an effective tool for enhancing patient safety by capturing valuable information from families about potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. Daniels, JP., King, AD., Cochrane, DD., et al.[2022]

A study involving 91 interviews with relatives of hospitalized pediatric patients identified various safety incidents, including issues related to drug therapy, hygiene, diet, falls, communication, patient identification, care processes, and access to healthcare facilities.

The findings highlight the importance of involving families in the care process to help minimize risks and complications for hospitalized children, suggesting a need for strategies that enhance family integration in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety incidents reported by relatives of hospitalized children. Hoffmann, LM., Rodrigues, FA., Biasibetti, C., et al.[2021]

Patient Family Relations (PFR) programs effectively capture patient and family concerns in hospitals, revealing that the most common issues are related to care/treatment and communication.

There is a significant mismatch (around 80%) between the data collected by PFR programs and the AHRQ Common Format, highlighting the need for improved reporting systems to better analyze safety data in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Analytics of the Patient and Family Perspective: A Case Study and Recommendations for Data Capture of Safety and Quality Concerns. Couture, B., Fagan, M., Gershanik, E., et al.[2019]

A mobile health tool was successfully piloted in a children's hospital, allowing patients and family members to report safety observations in real-time, resulting in 8.15 reports per 100 patient-days, primarily concerning medications and communication.

The system identified safety issues that were not reported through traditional incident reporting systems, highlighting the potential for technology to enhance patient safety and the need to address disparities in reporting among different demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Input for Quality and Safety (FIQS): Using mobile technology for in-hospital reporting from families and patients. Bardach, NS., Stotts, JR., Fiore, DM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05407129

Patients and Families Improving Safety in Hospitals by ... After piloting the intervention in one inpatient unit, marked improvements in family safety reporting and reductions in disparities in reporting by parent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12364509/

Patient and family engagement interventions in primary care ... Patient and family engagement strategies go beyond raising awareness about care safety and can encompass partnerships between patients/families and healthcare ...

3. withpower.com withpower.com/trial/family-safety-reporting-for-patient-safety-be99f

Family Safety Reporting for Patient Safety (I-SHARE Trial) What data supports the effectiveness of the Family Safety Reporting Intervention treatment? Research shows that involving patients and families in safety ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39224086

A Coproduced Family Reporting Intervention to Improve ... We compared safety-reporting baseline (via survey) versus intervention (via survey and/or mobile tool) with generalized estimating equations and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000577

The effectiveness of checklists and error reporting systems ... The review highlights evidence supporting the efficacy of checklists in reducing medication errors, surgical complications, and other adverse events.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184738/

A Coproduced Family Reporting Intervention to Improve ... This article describes changes in safety reporting after implementing a health literacy informed, reminder-based, mobile family-safety-reporting ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK597671/

Patient and Family Engagement - Making Healthcare Safer IV For this review, we define PSPs focused on patient and family engagement as any intervention specifically designed to promote engagement of patients and/or ...

8. bmj.com bmj.com/content/363/bmj.k4764

Patient safety after implementation of a coproduced family ... Importantly, we also directly measured safety outcomes using an expanded active surveillance methodology that included family safety reporting.