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OpenTrials
Completed

NCT Number: NCT02877017

Family Activation and Communication About Errors and Safety (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.

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Key information

Conditions

Family Reported Errors and Adverse Events

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family safety reporting intervention

Behavioral

family safety reporting intervention for families and providers

Primary outcomes

  1. Family Safety Reporting Rates

    Time frame: 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.

    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.

Secondary outcomes

  1. Family Reported Hospital Safety Climate Scores

    Time frame: 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.

    For Family Reported Hospital Safety Climate Scores, Child HCAHPS safety experience was used to ask whether hospital staff told participants how to report concerns about mistakes. We examined top-box (top-most, e.g., 5 of 5, Likert scale) safety climate scores baseline vs intervention and proportion of parents reporting "yes definitely" or "yes somewhat" vs "no" to the Child HCAHPS "tell you how to report" question.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Acronym: FACES

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2016
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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