Trial Outcomes & Findings for Family Activation and Communication About Errors and Safety (FACES) (NCT NCT02877017)

Last Updated: 2025-04-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

985 participants

Primary outcome timeframe

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 posted on

2025-04-01

Participant Flow

The protocol enrollment reflects participants who are families of hospitalized children and providers among the hospital units. The Participant Flow reflects only families of hospitalized children that participated in the mobile tool aspect of the intervention, which the "Providers" group did not participate in and therefore are not included here.

Participant milestones

Participant milestones
Measure	Pre-intervention Arm This arm is the pre-intervention arm of participants before the family safety reporting bundle has been implemented.	Post-intervention Arm This arm is the post-intervention arm of participants after the family safety reporting bundle has been implemented on the study units. Family safety reporting intervention: family safety reporting intervention for families and providers
Overall Study STARTED	232	208
Overall Study COMPLETED	207	157
Overall Study NOT COMPLETED	25	51

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Population: We included English/Spanish-speaking parents of patients of all ages hospitalized on the complex care service.

Outcome measures

Outcome measures
Measure	Pre-intervention Arm n=207 Participants This arm is the pre-intervention arm of parents and providers before the family safety reporting bundle has been implemented.	Post-intervention Arm n=157 Participants This arm is the post-intervention arm of parents and providers after the family safety reporting bundle has been implemented on the study units. Family safety reporting intervention: family safety reporting intervention for families and providers
Family Safety Reporting Rates	61 Participants	60 Participants

SECONDARY outcome

Timeframe: 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.

Population: We included English/Spanish-speaking parents of patients of all ages hospitalized on the complex care service.

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.

Outcome measures

Outcome measures
Measure	Pre-intervention Arm n=182 Participants This arm is the pre-intervention arm of parents and providers before the family safety reporting bundle has been implemented.	Post-intervention Arm n=151 Participants This arm is the post-intervention arm of parents and providers after the family safety reporting bundle has been implemented on the study units. Family safety reporting intervention: family safety reporting intervention for families and providers
Family Reported Hospital Safety Climate Scores	66 Participants	69 Participants

Adverse Events

Pre-intervention Arm

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Post-intervention Arm

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-intervention Arm n=232 participants at risk This arm is the pre-intervention arm of participants (families of children with medical complexity) whose children had monitored/assessed adverse events before the family safety reporting bundle had been implemented on the study units.	Post-intervention Arm n=208 participants at risk This arm is the post-intervention arm of participants (families of children with medical complexity) whose children had recorded adverse events after the family safety reporting bundle had been implemented on the study units.
General disorders Serious Adverse Events	0.00% 0/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.00% 0/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.

Other adverse events

Other adverse events
Measure	Pre-intervention Arm n=232 participants at risk This arm is the pre-intervention arm of participants (families of children with medical complexity) whose children had monitored/assessed adverse events before the family safety reporting bundle had been implemented on the study units.	Post-intervention Arm n=208 participants at risk This arm is the post-intervention arm of participants (families of children with medical complexity) whose children had recorded adverse events after the family safety reporting bundle had been implemented on the study units.
Cardiac disorders Other Adverse Events	0.43% 1/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.00% 0/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Gastrointestinal disorders Other Adverse Events	0.86% 2/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.96% 2/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Infections and infestations Other Adverse Events	0.86% 2/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.96% 2/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Injury, poisoning and procedural complications Other Adverse Events	0.86% 2/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	2.4% 5/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Musculoskeletal and connective tissue disorders Other Adverse Events	0.00% 0/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.48% 1/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Nervous system disorders Other Adverse Events	1.3% 3/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	4.8% 10/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Product Issues Other Adverse Events	0.00% 0/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.48% 1/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Renal and urinary disorders Other Adverse Events	0.43% 1/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.00% 0/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Skin and subcutaneous tissue disorders Other Adverse Events	0.86% 2/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.00% 0/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.
Surgical and medical procedures Other Adverse Events	0.43% 1/232 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.	0.96% 2/208 • Time on study unit, from admission to discharge, on average approximately 9 days. Documented system-wide adverse event reports were reviewed and evaluated on a weekly basis. Of note, we collected adverse events as part of this study's primary outcome and all the events reported below are unrelated to the study intervention. We collected events through family safety reporting and hospital collected events which were then chart reviewed.

Additional Information

Alisa Khan, MD, MPH

Boston Children's Hospital

Phone: 6173552565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Pre-intervention Arm n=207 Participants This arm is the pre-intervention arm of participants before the family safety reporting bundle has been implemented.	Post-intervention Arm n=157 Participants This arm is the post-intervention arm of participants after the family safety reporting bundle has been implemented on the study units. Family safety reporting intervention: family safety reporting intervention for families and providers	Total n=364 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 11 • n=207 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	45 years STANDARD_DEVIATION 10 • n=157 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	46 years STANDARD_DEVIATION 11 • n=364 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Sex: Female, Male Female	168 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	134 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	302 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Sex: Female, Male Male	37 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	21 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	58 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized American Indian or Alaskan Native, Non- Hispanic	1 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	0 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	1 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized Asian/Pacific Islander, non-Hispanic	5 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	4 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	9 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized Black/African-American, non-Hispanic	9 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	9 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	18 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized Hispanic	30 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	34 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	64 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized Multi-racial, non-Hispanic	4 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	1 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	5 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized Other, non-Hispanic	4 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	2 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	6 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Race/Ethnicity, Customized White, non-Hispanic	152 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	105 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	257 Participants n=360 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Region of Enrollment United States	207 Participants n=207 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	157 Participants n=157 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	364 Participants n=364 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
English Proficiency Proficient	174 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	132 Participants n=154 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	306 Participants n=359 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
English Proficiency Limited English Proficient	31 Participants n=205 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	22 Participants n=154 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	53 Participants n=359 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Education Attainment Less than college	105 Participants n=206 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	85 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	190 Participants n=361 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).
Education Attainment Completed college or higher	101 Participants n=206 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	70 Participants n=155 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).	171 Participants n=361 Participants • We enrolled 440 participants overall (pre-intervention=232, post-intervention=208). Of these, 364 (82.7%) completed surveys (pre-intervention=207, post-intervention=157).