Family Reported Errors and Adverse EventsFACESNCT02877017
Family Activation and Communication About Errors and Safety (FACES)
A study testing Family safety reporting intervention in people with Family Reported Errors and Adverse Events, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Reported Errors and Adverse Events
- What is being tested?
- Family safety reporting intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 985 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- International patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
- Being tested
- Family safety reporting intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family safety reporting interventionBehavioural
family safety reporting intervention for families and providers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family safety reporting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start5 Apr 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Family Reported Errors and Adverse EventsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pre-post intervention study
- Masking
- None (open label)
- Enrolment
- 985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alisa Khan, Boston Children's Hospital
- Investigators
- Alisa Khan, MD, MPH, Principal investigator, Boston Children's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877017
- Sponsor's protocol ID
- IRB-P00022336
- Acronym
- FACES
- Status last verified
- Mar 2025
- First submitted
- 17 Aug 2016
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Activation and Communication About Errors and Safety (FACES)
- ClinicalTrials.gov ID
- NCT02877017
- Acronym / sponsor ID
- FACES / IRB-P00022336
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 985 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 1 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Family safety reporting interventionThis arm is the post-intervention arm of parents and providers after the family safety reporting bundle has been implemented on the study units. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- International patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family safety reporting interventionfamily safety reporting intervention for families and providers | Behavioural | Post-intervention arm |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Family Reported Errors and Adverse Events
Recruiting
Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences
Family Reported Errors and Adverse Events, Health Disparities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisa Khan, MD, MPH principal investigator
Boston Children's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family safety reporting intervention in people with Family Reported Errors and Adverse Events, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.