Family Activation and Communication About Errors and Safety (FACES)

NCT02877017 | Completed Results

• 1 other identifier: IRB-P00022336
• Study Type: interventional
• Target: 985
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Family Reported Errors and Adverse Events

Outcome Measures

Primary Outcomes (1)

• Family Safety Reporting Rates

  Our primary outcome was family-reported safety concerns, defined as reporting safety concern(s) via pre-discharge survey (baseline and intervention) or mobile tool (intervention). Safety concerns were counted once if reported both via survey and mobile tool.

  During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days.

Secondary Outcomes (1)

• Family Reported Hospital Safety Climate Scores

  During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days.

Study Arms (2)

Pre-intervention arm

NO INTERVENTION

This arm is the pre-intervention arm of parents and providers before the family safety reporting bundle has been implemented.

Post-intervention arm

EXPERIMENTAL

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

Interventions

Family safety reporting intervention BEHAVIORAL

family safety reporting intervention for families and providers

Post-intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• International patients

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Results Point of Contact

• Title: Alisa Khan, MD, MPH
• Organization: Boston Children's Hospital

alisa.khan@childrens.harvard.edu

6173552565

Study Officials

• Alisa Khan, MD, MPH

  Boston Children's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics

Model Details: pre-post intervention study

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 24, 2016
• Study Start: April 5, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)