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

Trial Summary

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 data supports the effectiveness of the Family Safety Reporting Intervention treatment?

Research shows that involving patients and families in safety reporting can improve patient safety, especially when they are engaged at both the information and involvement levels. However, the effectiveness of these interventions can vary, and more rigorous studies are needed to confirm their impact. ^{1 2 3 4 5}

Is the Family Safety Reporting System safe for use in humans?

The Family Safety Reporting System has been studied in hospital settings to help detect medical errors and improve patient safety by gathering reports from families. While the research focuses on improving safety reporting, it does not specifically mention any safety concerns related to the use of the system itself. ^{3 4 6 7 8}

How does the Family Safety Reporting treatment differ from other treatments for patient safety?

The Family Safety Reporting treatment is unique because it involves capturing safety concerns directly from patients and their families, rather than relying solely on clinicians. This approach uses mobile technology and web-based systems to gather real-time safety observations, providing a more comprehensive view of patient safety incidents. ^{3 4 7 8 9}

What is the purpose of this trial?

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.

Research Team

Alisa Khan, MD, MPH

Principal Investigator

Boston Children's Hospital/Harvard Medical School

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Critical incident monitoring in paediatric and adult critical care: from reporting to improved patient outcomes? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Interventions to Engage Patients and Families in Patient Safety: A Systematic Review. [2022]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Whose Voices are Heard in Patient Safety Incident Reports? [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Families as Partners in Hospital Error and Adverse Event Surveillance. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Family Input for Quality and Safety (FIQS): Using mobile technology for in-hospital reporting from families and patients. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Patient safety incidents reported by relatives of hospitalized children. [2021]