Family Activation and Communication About Errors and Safety (FACES)

NCT ID: NCT02877017

Last Updated: 2025-04-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

985 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Family Reported Errors and Adverse Events

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

pre-post intervention study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pre-intervention arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Family safety reporting intervention

Intervention Type BEHAVIORAL

family safety reporting intervention for families and providers

Interventions

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Family safety reporting intervention

family safety reporting intervention for families and providers

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alisa Khan

Assistant Professor, Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alisa Khan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital/Harvard Medical School

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-P00022336

Identifier Type: -

Identifier Source: org_study_id

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