Family Activation and Communication About Errors and Safety (FACES) (FACES)

Miscommunications are a leading cause of serious medical errors in hospitals, contributing to more than 60% of sentinel events, the most serious adverse events reported to the Joint Commission. Efforts to improve patient safety in hospitals have centered on improving communication between providers. While provider-focused communication interventions have led to reductions in patient harm, patients and families have been notably absent from most interventions to improve patient safety. This proposal seeks to develop a family safety reporting intervention.

Study Overview

• Status: Completed
• Conditions: Family Reported Errors and Adverse Events
• Intervention / Treatment: Behavioral: Family safety reporting intervention

• Study Type: Interventional
• Enrollment (Actual): 985
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary caregiver of a child hospitalized on the study units during the study period or hospital employee who works on the study unit(s)
• Country of Origin: United States
• Primarily English- or Spanish-speaking

Exclusion Criteria:

• International patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention arm; This arm is the pre-intervention arm of parents and providers before the family safety reporting bundle has been implemented.
Experimental: Post-intervention arm; This arm is the post-intervention arm of parents and providers after the family safety reporting bundle has been implemented on the study units.	Behavioral: Family safety reporting intervention; family safety reporting intervention for families and providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
family safety reporting rates	12 months
experience with safety reporting	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
hospital safety culture scores	12 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Alisa Khan, MD, MPH, Boston Children's Hospital/Harvard Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00022336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No