Family Activation and Communication About Errors and Safety (FACES)
Phase: NA
Conditions: Family Reported Errors and Adverse Events
Sponsor: Boston Children's Hospital

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FACES Protocol 11.13.2023 
 
 
 
Protocol Title 
Family Activation and Communication about Errors and Safety (FACES) Study 
Protocol #s: NCT02877017 (ct.gov) 
 
Principal Investigator (PI) 
Alisa Khan, MD, MPH, Boston Children’s Hospital 
 
Coordinating Center 
Division of General Pediatrics, Boston Children’s Hospital 
 
Supported/Funding 
Agency for Healthcare Research & Quality grant K08HS025781 
 
 
 
Last Updated:  November 13, 2023 
 
 
 
 
 
 
 

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FACES Protocol 11.13.2023 
TABLE OF CONTENTS  
TABLE OF CONTENTS ............................................................................................................ 2 
1 
PROTOCOL SUMMARY ................................................................................................... 5 
1.1 
Synopsis .................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................... 6 
2.1 
Study Rationale ......................................................................................................... 6 
2.2 
Background ............................................................................................................... 6 
2.3 
Risk/Benefit Assessment .......................................................................................... 7 
3 
OBJECTIVES AND ENDPOINTS ..................................................................................... 8 
4 
STUDY DESIGN............................................................................................................... 10 
4.1 
Overall Design ........................................................................................................ 10 
4.2 
Scientific Rationale for Study Design..................................................................... 10 
4.3 
Justification for Intervention ................................................................................... 11 
4.4 
End-Of-Study Definition ........................................................................................ 11 
5 
STUDY POPULATION .................................................................................................... 11 
5.1 
Inclusion Criteria .................................................................................................... 11 
5.2 
Exclusion Criteria ................................................................................................... 11 
5.3 
Inclusion of Vulnerable Participants ....................................................................... 12 
5.4 
Inclusion of Pregnant Women, fetuses or neonates ................................................ 12 
5.5 
Lifestyle Considerations ......................................................................................... 12 
5.6 
Screen Failures ........................................................................................................ 12 
5.7 
Strategies for Recruitment and Retention ............................................................... 12 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ................ 13 
6.1 
Study Interventions(s) or Experimental Manipulations(s) Administration ............ 13 
6.2 
Fidelity .................................................................................................................... 14 
6.3 
Measures to Minimize Bias: Randomization and Blinding .................................... 14 
6.4 
Study Intervention/Experimental Manipulation Adherence ................................... 14 
6.5 
Concomitant Therapy.............................................................................................. 14 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION 
AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ............................................ 15 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation....................... 15 
7.2 
Participant Discontinuation/Withdrawal from the Study ........................................ 15 

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7.3 
Lost to Follow-up .................................................................................................... 15 
8 
STUDY ASSESSMENTS AND PROCEDURES ............................................................. 15 
8.1 
Screening Procedures .............................................................................................. 15 
8.2 
Study Evaluations & Procedures ............................................................................ 15 
8.3 
Safety Assessments ................................................................................................. 16 
8.4 
Adverse Events and Serious Adverse Events ......................................................... 16 
8.5 
Unanticipated Problems .......................................................................................... 18 
9 
STATISTICAL CONSIDERATIONS............................................................................... 19 
9.1 
Statistical Hypothesis .............................................................................................. 19 
9.2 
Sample Size Determination..................................................................................... 19 
9.3 
Populations for Analyses ........................................................................................ 19 
9.4 
Statistical Analyses ................................................................................................. 19 
10 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS ..... 21 
10.1 
Informed Consent Process ...................................................................................... 21 
10.2 
Study Discontinuation and Closure ........................................................................ 21 
10.3 
Confidentiality and Privacy .................................................................................... 22 
10.4 
Future use of Stored Specimens and Data .............................................................. 23 
10.5 
Safety Oversight...................................................................................................... 23 
10.6 
Clinical Monitoring ................................................................................................. 23 
10.7 
Quality Assurance and Quality Control .................................................................. 23 
10.8 
Data Handling and Record Keeping ....................................................................... 23 
10.9 
Protocol Deviations and Non-Compliance ............................................................. 23 
10.10 
Human Data Sharing, including Genomic Data Sharing, and Publication ............. 24 
10.11 
Collaborative Agreements ...................................................................................... 24 
10.12 
Conflict of Interest Policy ....................................................................................... 24 
11 
ABBREVIATIONS ........................................................................................................ 24 
12 
REFERENCES ............................................................................................................... 25 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS 
Title: 
Family Activation and Communication about Errors and Safety (FACES) 
Study 
 
Study Description: 
 
Miscommunications are a leading cause of serious medical errors in 
hospitals, contributing to more than 60% of sentinel events, the most serious 
adverse events (AEs) 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 and investigate the effectiveness of a family safety 
engagement intervention aimed at reducing harm in hospitalized children, 
especially children with medically complex conditions. Families have the 
potential to serve as partners in safety surveillance and prevention, 
particularly in pediatrics. Research about the role of patients and families in 
safety efforts is limited, particularly regarding the effectiveness of 
intervention strategies to engage patients and families as partners in safety, 
and the effect of such interventions on patient safety and family experience. 
 
Objectives: 
 
 
1. Explore, using qualitative methods, parent, provider, and hospital 
leader perceptions of barriers to and facilitators of family 
engagement in hospital safety reporting in order to inform 
development of FACES 
2. Develop and evaluate FACES using multiple methodologies: 
- 
Develop a feasible and acceptable version of FACES, informed 
by 
qualitative 
methods, 
communication 
science, 
and 
organizational behavior 
- 
Pilot FACES with a small group of parents to evaluate rates of 
reporting and experience (using quantitative survey data) in 
order to develop a final version of FACES 
 
Endpoints: 
A final FACES intervention to further test in an R01 
 
Study Population: 
English- and Spanish-speaking parents of hospitalized children with 
medical complexity (CMC) 
 
Phase or Stage: 
N/A 
 
Description of 
Sites/Facilities 
Enrolling Participants: 
This study will be conducted at a quaternary academic center with a 
dedicated, multi-unit, non-geographic complex care service.   
 
 
Description of Study 
Intervention: 
The FACES intervention will consist of (1) a family safety reporting tool for 
routine operational use, adapted from reporting tools used in research, 

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supplemented with (2) family activation strategies and education about 
safety, and (3) provider training about family engagement in safety 
 
Study Duration: 
4 years 
 
Participant Duration: 
Duration of inpatient hospitalization 
 
 

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2 
 INTRODUCTION 
2.1 
STUDY RATIONALE 
The “Family Activation and Communication about Errors and Safety (FACES)” intervention aim 
to engage families of children with medical complexity (CMC) in real-time hospital safety 
reporting. FACES will be informed by qualitative methods, communication science, and 
organizational behavior principles. FACES will operationalize family safety reporting in a 
pediatric hospital setting among CMC, which has not been done previously. It will uniquely draw 
on patient and family activation principles, which are not widely applied to or studied in hospital 
safety. 
2.2 
BACKGROUND  
Recent studies suggest that as many as 250,000 US patients may die annually from medical 
errors.1 There is growing interest in the role that patients and families play in identifying medical 
errors and adverse events (AEs, or harms due to medical care).2–6 Patients and families can serve 
as “vigilant partners”7 in safety, given their intimate knowledge of patients’ histories, motivation for 
a good outcome, availability, and proximity.8 This may be particularly true in pediatrics and for 
families of children with medical complexity (CMC), an AHRQ priority population. CMC are 
children with complex chronic conditions (CCCs, an ICD-9–based marker of medical complexity)9 
affecting multiple organ systems and severe functional limitations who require multiple 
medications and medical equipment to optimize health.10 Hospitalized CMC are particularly prone 
to errors due to increased length of stay, number of medications, and providers’ cognitive load.11–
15  
Several studies suggest that patients and families identify medical errors and AEs 
otherwise undocumented in the medical record.3,5,6,16 Most hospitals, however, do not 
actively solicit patient or family reports about errors and AEs. Instead, most voluntary 
hospital incident-reporting systems, which capture a small percentage of safety 
incidents,17–19 include only providers. However, providers recognize and report fewer than 
1 in 7 errors and harms that are detected on systematic surveillance.20 
Patients and families appear interested in engaging in safety efforts21–23 and providers 
appear to support their involvement.21,22,24,25 However, interpersonal, cultural, and other 
barriers interfere with patient activation and involvement in  reporting.26 These include 
failure to recognize a safety event or its severity, patient characteristics (e.g., medical 
complexity), parent characteristics (e.g., education, health literacy), cues to action (e.g., 
providers effectively activating families about safety), and perceived reporting benefits vs. 
barriers (Figure 2, adapted from the Health Belief Model27).  
Additionally, parents are often unaware of how to report hospital safety concerns. In 
a 69-hospital field test of the Child Hospital Consumer Assessment of Healthcare 
Providers and Systems (Child HCAHPS) survey,28 parents’ lowest-rated measure of 
hospital experience was whether the hospital took steps to prevent mistakes and told 
parents how to report concerns, with an average “top-box” score of only 55%.29 
Efforts to incorporate patients and families in hospital safety are increasing.30–32 
However, family engagement in safety reporting has not yet been operationalized in 
hospital settings. In a recent report, AHRQ described a recent 2-hospital pilot of a 
voluntary phone and online reporting system for patients and caregivers, the Health Care 

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Safety Hotline.33 This pilot found that a centralized system for reporting safety events was 
feasible, with patients and their families providing useful, often otherwise undetected 
information. However, the system suffered from low reporting rates (only 37 safety reports 
from 91,325 admissions, or 0.04% of admissions).34 These numbers are dramatically 
lower than those documented in other studies, which find medical errors in 25–50% of 
hospital admissions.35,36 The report suggests several strategies to enhance reporting 
rates, such as incorporating safety screening questions into patient experience surveys.33 
2.3 
RISK/BENEFIT ASSESSMENT 
2.3.1 Known Potential Risks 
The main risk for this study is the potential loss of confidentiality. Because this study intends to 
track reporting of medical errors, participation does pose possible, though highly unlikely, 
confidentiality and legal risks. Reports of adverse events in relation to the intervention will be 
forwarded to the principal investigator and then, as standard practice dictates, to the IRB. In 
addition, if we discover any serious errors in evolution that pose a risk to the patient, of which the 
clinical team is not already aware, we will address these directly with the clinical team, including 
the attending physician. In such cases, we will follow hospital guidelines for error reporting. In 
these rare instances, there is some risk to the confidentiality of study participants. However, any 
such issues will be preferentially addressed directly with the immediate care team, with 
involvement of supervisors and more senior personnel only where necessary in order to ensure 
patient safety. 
2.3.2 Known Potential Benefits 
The proposed research project may not pose direct benefits to participants. However, information 
gathered during the study may help activate families to engage in safety reporting. Hospital staff 
and parents may learn useful strategies for family activation and optimizing involvement of 
families in hospital safety efforts. The societal benefits from information gained through the 
proposed project are potentially large. Provider, parent, and hospital system barriers to and 
facilitators of family engagement in safety reporting may be better understood. More may be 
learned about the frequency and types of errors experienced by hospitalized pediatric patients. If 
successful, the project could produce a feasible and operational family safety reporting mechanism 
with the potential to inform structural integration of family voices into hospital error surveillance 
more widely. Ultimately, the project could inform efforts to prevent medical error and harm. Given 
what is already known about the frequency of medical errors and harm in hospitals, the potential 
benefits of this research outweigh its possible risks. 
2.3.3 Assessment of Potential Risks and Benefits 
Given the precautions that will be taken to protect study data and maintain participant 
confidentiality, the risk of a confidentiality breach is unlikely. If evidence of a serious medical 
error in evolution of which the team is not already aware becomes known, this information will be 
communicated to the attending physician of the medical team, who will then take action at his/her 
discretion. Prior research has demonstrated that even in direct observation, it is rare to find harmful 
errors in evolution that pose a clinical risk to the patient and of which the clinical team is not 
already aware. The research assistant will be trained such that, in cases where they feel there is an 
emergent need to intervene, they will immediately contact responsible clinical staff. In cases that 
are less time-emergent, they will contact the study Principal Investigator and discuss the case 

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before deciding how best to proceed. However, regardless of these safeguards, participants will 
always be participant to hospital protocols regarding error reports, and there is a slight risk that, in 
the event of legal action, a court could compel us to release the information. Of note, AHRQ has 
a Certificate of Confidentiality that provides additional privacy benefits. 
 
3 
OBJECTIVES AND ENDPOINTS  
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
Develop a family safety reporting 
intervention.  
 
 
Creation of a feasible and acceptable 
family safety reporting intervention.  
Developing an 
operational 
intervention for family 
safety reporting that is 
feasible and acceptable 
to both families and 
staff will help hospitals 
identify otherwise 
unrecognized and 
patient/family 
prioritized areas of 
safety and quality 
improvement.   
Secondary 
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Increasing family safety reporting 
in hospitals.   
 
 
Rates of family safety reporting pre 
versus post intervention. 
 
 
 
Currently, families 
informally share safety 
and quality concerns 
frequently with their 
providers which leads 
to variable and often 
local improvement. 
However, formal 
mechanisms for 
families to proactively 
share are limited, 
which limited the 
ability of hospitals to 
hear from families in a 
systematic matter, 
address concerns 
globally, and improve 
safety and quality. We 
seek to understand 
whether creation of a 
feasible and acceptable 
family safety reporting 
intervention increases 
formal reporting from 
families in a 
systematically captured 
matter that the hospital 
can use for 
improvement.  
 
Tertiary/Exploratory  
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Increasing family safety reporting 
in hospitals by families who might 
not otherwise report.   
 
 
 
Rates of family safety reporting pre 
versus post intervention among families 
with lower educational attainment. 
 
 
Families who have 
lower educational 
attainment have 2-5 
lower odds of sharing 
safety concerns. Given 
our intervention is 
informed by health 
literacy, qualitative 
methods, and 
communication science, 
we hypothesize that 
families with lower 
educational attainment 
may be more likely to 
report than otherwise 
after intervention 
implementation. 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
Prospective cohort pre-post intervention study 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
A parent-nurse-physician-hospital leader team will coproduce the FACES intervention. FACES 
involves (1) an English/Spanish mobile (email/text/QR) family-safety-reporting tool (“Comment 
Card,” CC) with regular reminders, (2) staff/family education, and (3) a process for 
reviewing/sharing comments regularly with unit/hospital leaders. Pre- and post-intervention, we 
will survey families pre-discharge about safety concerns. Post-intervention only, families will also 
be prompted to complete the FACES CC, which includes examples of events with definitions.  
FACES is informed by qualitative interviews, health literacy, communication science, and 
organizational behavior.  

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4.3 
JUSTIFICATION FOR INTERVENTION 
Miscommunications are a leading cause of serious medical errors in hospitals, contributing to more 
than 60% of sentinel events, the most serious adverse events (AEs) 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 study seeks to develop and investigate the 
effectiveness of a family safety reporting intervention aimed at reducing harm in hospitalized 
children, especially children with medically complex conditions. Families have the potential to 
serve as partners in safety surveillance and prevention, particularly in pediatrics. Research about 
the role of patients and families in safety efforts is limited, particularly regarding the effectiveness 
of intervention strategies to engage patients and families as partners in safety, and the effect of 
such interventions on patient safety and family experience. 
4.4   END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed study surveys 
and been discharged from inpatient care.  
5 
STUDY POPULATION 
We will recruit parents (i.e., primary caregivers), physicians, nurses, and hospital leaders of CMC 
hospitalized on the complex care service of the study center. CMC will be defined as children 
under the age of 18 and with greater than or equal to 3 complex chronic conditions, along with 
neurologic impairment or technology dependence. We will use purposeful sampling criteria to 
include parents from varied racial/ethnic, cultural, and socioeconomic backgrounds. As we found 
differences in family reporting by education in prior research,37 we will ensure half our parent 
participants have ≤high school education. This sampling will help us develop a culturally relevant 
intervention informed by diverse perspectives. We will include hospital leaders in medical/nursing, 
safety/ quality, patient advocacy, and legal roles; resident and attending physicians; and bedside 
and charge nurses. 
5.1 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Admitted on a study-affiliated unit 
2. English- and/or Spanish-speaking 
5.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. In Department of Children and Families (DCF) custody 
2. International patient 
3. Boarding for psychiatric placement  
4. Will be discharged from hospital directly to a residential care facility 

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5.3 
INCLUSION OF VULNERABLE PARTICIPANTS 
N/A 
5.4 
INCLUSION OF PREGNANT WOMEN, FETUSES OR NEONATES 
N/A 
5.5 
LIFESTYLE CONSIDERATIONS 
N/A 
5.6 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but do not 
subsequently receive the study intervention or participate in the study. Individuals who do not meet 
the criteria for participation in this trial (screen failure) because of meeting one or more exclusion 
criteria that are likely to change over time may be rescreened.  
5.7 
STRATEGIES FOR RECRUITMENT AND RETENTION 
We will recruit parents and staff (including physicians, nurses, medical students, nursing students, 
other support staff) of patients hospitalized in pediatric units as well as hospital leaders. Eligible 
parents will be domestic/non-international primary caregivers of children who are hospitalized 
during the study period. English- and Spanish-speaking parents will be eligible. All physicians, 
nurses, students, and support staff employed on the study units will be eligible to participate. We 
will also recruit hospital leaders in medical, nursing, safety, quality, patient advocacy, and legal 
roles. We will include parents from varied racial/ethnic and socioeconomic backgrounds to ensure 
diverse perspectives. Since we found differences in parent error-reporting by education in prior 
studies,37 we will purposefully sample parent participants to ensure that half have lower levels of 
education (e.g., high school or less). We will also include parents from varied racial/ethnic and 
socioeconomic backgrounds to ensure diverse perspectives. Patient medical records will be 
reviewed for screening purposes (only the minimum amount of information required to confirm 
eligibility or lack thereof will be reviewed) and screen-positive families will be approached by 
study staff on the hospital unit. If families are not present on the unit (we are told by providers that 
families are often not present for a majority of the hospitalization), we will call, email, and/or 
teleconference (e.g., via Zoom) the screen-positive families to recruit, consent, and administer 
surveys (if the family consents), or to determine an interested family's preferred time of future 
contact. Once approached, study staff will actively collect email addresses and mailing addresses 
(or verify previously entered emails and mailing addresses from the medical record) for 
consenting, interview scheduling, survey administration, and renumeration delivery purposes. For 
eligible providers and staff, study staff will make the first contact by email or in-person to gauge 
interest in participation and consent participants. Interviewees may be asked to participate as key 
informants in more than one cycle of qualitative interviews. We may use hospital interpreters or 
Spanish-speaking staff to recruit, consent, and conduct interviews with eligible Spanish-speaking 
families; the staff will be trained in our qualitative interview guide. Participants will be made aware 
that they are free to discontinue participation in the study at any time and that the investigators 
reserve the right to discontinue the protocol at any time. We will meet and/or email with each 
potential participant, acquaint him or her with the study procedures, and obtain informed consent 
(through method other than written consent, i.e., verbal, email, or survey completion-based 
consent) for study enrollment. 

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5.7.1 Costs 
N/A 
5.7.2 Compensation 
Parent and staff participants will rceive a $25 gift card after completing a one-one-one qualitative 
interview. Parents will receive small snacks or gift cards (e.g., $5) for completing surveys. Staff 
participants will receive either a small snack/meal (e.g., pizza lunch) or receive a $5 gift card for 
completing surveys. Tokens will be given in-person, distributed via email (e-gift card), or mailed 
if a parent participates but is unable to receive tokens in-person (e.g., participates via phone or 
Zoom and will not be visiting hospital prior to their child's discharge, or staff unable to deliver 
token in-person due to COVID-19 policies). 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 
STUDY INTERVENTIONS(S) OR EXPERIMENTAL MANIPULATIONS(S) ADMINISTRATION 
6.1.1 Study Intervention and Data Collection Description 
In partnership with families, nurses, physicians, and hospital leaders, we will design a safety-
reporting intervention for families of hospitalized CMC to share safety concerns, comments, and 
suggestions.  
Pre- and post-intervention, we will survey families before they are discharged from the hospital 
about safety concerns. Our survey, which is based on prior research2,37,38 will provide examples of 
mistakes and safety issues (e.g., medication problems, equipment problems, communication 
problems, diagnostic mistakes). It will ask families to share whether their illness got worse because 
of medical care or something wasn’t done that should have been, a mistake that didn’t cause harm 
occured, a “good catch” occurred, their concerns not heard, or anything else upsetting or 
potentially harmful occured. Parents will also complete questions about safety climate (from the 
Children’s Hospital Safety Climate Questionnaire measure39) and whether the hospital told them 
how to report safety concerns (from the Child HCAHPS measure28). They will also be assessed 
for level of health literacy (via the Newest Vital Sign40), parent patient-activation (via P-PAM41), 
language proficiency (via US Census questions), and demographics (e.g., self-reported race and 
ethnicity, education). 
Post-intervention only, families will also be prompted to complete the FACES comment card, 
which will include examples of events with definitions. Parents will be told to report concerns both 
via comment card and survey. 
Surveys, comment cards, and intervention materials will be professionally translated into Spanish 
and reviewed by a bilingual team member. Spanish responses will be translated professionally 
post-hoc (for surveys) and by hospital interpreter services within 24 business-hours (for comment 
cards). 
 
 
 

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6.1.2 Administration  
For our study's QI intervention, which will be iteratively refined using Plan-Study-Do-Acts aligned 
with QI principles, we are designing and implementing a mobile reporting safety application based 
on piloting with parents and continuous feedback from our intervention development working 
group. The intervention will involve a family brochure, a family safety comment card (via paper, 
email, SMS, or QR code), and staff education. The family safety comment card will be available 
on paper and electronically (the latter is housed in REDCap), both of which we will pilot and 
iteratively refine based on stakeholder feedback. Our REDCap link will make use of Twilio, a 
SMS-based communication platform to facilitate patient-facing communication. The SMS link 
will be used to provide a secure REDCap link via text. No safety reports will be transmitted to 
Twilio as it is merely serving as a tool for our institution’s REDCap platform to effectively text a 
secure REDCap link to enrolled participants. The REDCap link to the family safety comment card 
will be available via email, SMS, or QR code. Before we email or text the families the comment 
card, we will ask their permission to do so. A secure REDCap link to the comment card will be 
sent to them periodically during their admission via email or SMS. We will pilot the various 
components of the intervention, which is QI itself, with parents and staff and iteratively refine it 
accordingly in accordance with QI principles. In order to recruit families for the study, the research 
assistant will approach them after admission and provide them the info sheet and family brochure 
with enclosed safety comment card. The research assistant or investigator will obtain permission 
from the family to email or text them a secure REDCap link to the safety comment card 
periodically during admission. If they do not wish to receive email and text links to the comment 
card, they can still voluntarily complete the safety comment card via paper or QR code. The 
research assistant will also approach the family prior to or after discharge to administer the family 
survey. 
6.2 
FIDELITY 
6.2.1 Interventionist Training and Tracking 
Study staff will be trained by the PI and other study staff regarding intervention implementation 
and will be observed until they are capable of independently implementing the intervention. 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
N/A 
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
N/A 
6.5 
CONCOMITANT THERAPY 
N/A 
6.5.1 Rescue Therapy 
N/A 

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7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
N/A 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue a participant from the study for the following reasons: 
 Significant study intervention non-compliance, unless varying compliance is an aspect of 
the study objectives  
 Lost-to-follow up; unable to contact participant (see Section 7.3, Lost to Follow-Up) 
 Any event or medical condition or situation occurs such that continued collection of follow-
up study data would not be in the best interest of the participant or might require an 
additional treatment that would confound the interpretation of the study 
 The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 Screen failure 
 Participant has completed the study follow-up period 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to complete the study (e.g., 
surveys) and is unable to be contacted by the study site staff. The research assistant will attempt 
to contact the participant in person or by phone (if not present at bedside) to administer the missed 
study activities and ascertain if the participant wishes to and/or should continue in the study. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
SCREENING PROCEDURES 
8.1.1 Screening activities performed prior to obtaining informed consent 
Minimal risk activities that may be performed before the participant has signed a consent include 
the following:  
 Email, written, in person or telephone communications with prospective participants  
 Review of existing medical records  
8.1.2 Screening activities performed after a consent for screening has been signed 
N/A 
8.2 
STUDY EVALUATIONS & PROCEDURES 
8.2.1 Biospecimen Evaluations 
N/A 
8.2.2 Samples for Genetic/Genomic Analysis 
N/A 

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8.3 
 SAFETY ASSESSMENTS 
Our study focuses on patient safety in hospitals overall. We do not expect our intervention itself 
to be associated with any safety events. Thus, while we will obtain family-reported safety events, 
these events relate to their hospitalization, not the intervention or study procedures themselves. 
8.4 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.4.1 Definition of Adverse Event 
Adverse event means any untoward medical occurrence associated with the use of an intervention 
in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
8.4.2 Definition of Serious Adverse Events (SAE) 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of 
either the investigator or sponsor, it results in any of the following outcomes: death, a life-
threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a 
persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions, or a congenital anomaly/birth defect. Important medical events that may not result in 
death, be life-threatening, or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an emergency room 
or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse. 
8.4.3 Classification of an Adverse Event 
8.4.3.1 Severity of Event 
For adverse events (AEs) not included in the protocol defined grading system, the following 
guidelines will be used to describe severity.  
• Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities.  
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.] 
8.4.3.2 Relationship to Study Intervention/Experimental Manipulation 
All adverse events (AEs) will have their relationship to study procedures, including the 
intervention, assessed by an appropriately trained clinician based on temporal relationship and 
his/her clinical judgment. The degree of certainty about causality will be graded using the 
categories below.  
Related – The AE is known to occur with the study procedures, there is a reasonable possibility 
that the study procedures caused the AE, or there is a temporal relationship between the study 

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procedures and the event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study procedures and the AE. 
Not Related – There is not a reasonable possibility that the study procedures caused the event, 
there is no temporal relationship between the study procedures and event onset, or an alternate 
etiology has been established. 
OR 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within 
a reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study procedures) 
and in which other drugs or chemicals or underlying disease provides plausible explanations (e.g., 
the participant’s clinical condition, other concomitant treatments). 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an alternative, 
definitive etiology documented by the clinician. 
Of note, the FACES intervention itself and study procedures, which involve surveys and 
interviews, are very low-risk and unlikely to lead to or be related to any adverse events.  
 
8.4.3.3 Expectedness  
A clinician with appropriate expertise in hospital medicine will be responsible for determining 
whether an adverse event (AE) is expected or unexpected. An AE will be considered unexpected 
if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study procedures. 

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8.4.4 Time Period and Frequency for Event Assessment and Follow-Up 
Safety concerns obtained from the comment card will undergo real-time and biweekly review by 
a multidisciplinary team consisting of at least one each parent, nurse, physician, and research 
assistant. They will review patient charts for further information, brainstorm ensuing QI projects, 
and notify clinical staff if patient care is believed to be at risk.  All safety concerns (from survey 
and comment card) will also undergo post-hoc review by 3 trained physicians with patient safety 
expertise after they first separate and consolidate comments into unique concerns. Next, they will 
review and classify concerns based on prior research.2,37,38 They will assess each event’s clinical 
category (e.g., diagnosis), safety category (e.g., nonpreventable adverse events, harmful errors, 
nonharmful errors, hazards, non-safety-related quality issues, or neither, NCC MERP3 
classification, and whether the concern was communication-related.  
8.4.5 Adverse Event Reporting  
Adverse events detected by the FACES study will be reported to the primary care team. Of note, 
events found as part of the primary outcome of the study are not related and/or caused by the 
intervention. 
8.4.6 Serious Adverse Event Reporting  
N/A 
8.4.7 Events of Special Interest  
N/A  
8.4.8 Reporting of Pregnancy  
N/A 
8.5 
UNANTICIPATED PROBLEMS 
8.5.1 Definition of Unanticipated Problems (UP) 
Any incident, experience, or outcome that meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review Board 
(IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the participant population being studied; and 
• Related or possibly related to participation in the research (“possibly related” means there 
is a reasonable possibility that the incident, experience, or outcome may have been caused 
by the procedures involved in the research); and 
• Suggests that the research places participants or others (which many include research staff, 
family members or other individuals not directly participating in the research) at a greater 
risk of harm (including physical, psychological, economic, or social harm) than was 
previously known or expected. 
8.5.2  Unanticipated Problem Reporting  
The investigator will report unanticipated problems (UPs) to the Boston Children’s Hospital IRB.  

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9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESIS 
 Primary Endpoint: We hypothesize that rates of family safety reporting will increase post-
intervention.   
 Secondary Endpoint(s): We hypothesize that rates of family safety will increase post-
intervention among families with lower educational attainment. 
9.2 
SAMPLE SIZE DETERMINATION 
We will recruit a minimum of 77 parents of CMC to participate in this pilot and complete 
questionnaires about their experience using FACES. With a sample size of 77, we anticipate >80% 
power to detect an increase in reporting from 0.04% at baseline to 10% post-implementation, 
assuming a 2-sided α error of 0.05. This number of parents should be feasible to obtain, given the 
patient census and prior study participation rates in this unit (>80%). 
For qualitative interviews, we will collect data until we reach thematic saturation, which we expect 
to reach at around 20 interviews. We anticipate this will involve interviewing 8 parents, 4 
physicians, 4 nurses, and 4 hospital leaders (as themes may overlap among physicians, nurses, and 
hospital leaders). We chose these numbers to ensure diversity of opinions and multiple 
perspectives from all stakeholders in the family safety reporting process. However, we will adjust 
our sample size and interview more or fewer participants as needed. 
9.3 
POPULATIONS FOR ANALYSES 
All participants (both staff and families/caregivers of CMC) who consented to enroll in the study 
and contributed data via surveys, comment card, or interviews.  
9.4 
STATISTICAL ANALYSES 
9.4.1 General Approach 
Our primary outcome is family-reported safety concerns, which we define as reporting a safety 
concern via pre-discharge survey (pre- and post-intervention) or FACES comment card (post-
intervention). Safety concerns will be counted once if reported both via survey and comment card. 
Secondary outcomes include safety experience (Child HCAHPS measure) and safety climate 
scores.  
Patient/family characteristics and study outcomes will be descriptively summarized using means 
(SD) for continuous variables and proportions for categorical variables. Comparisons of 
characteristics according to pre- vs post-intervention group will use Chi-square tests for categorical 
variables. The Shapiro-Wilk test will test normality for continuous variables. T-tests will be used 
for normally distributed continuous variables and Wilcoxon Rank-Sum Tests for nonparametric 
continuous variables. 
We will use generalized estimating equation (GEE) models to examine association between safety 
concerns and intervention-period, adjusting for patient/family characteristics that vary pre/post-
intervention and within-patient clustering. We will also conducted subgroup analyses by education 
and cases (pre- and post-intervention) occurring during the COVID-19 pandemic (7/2020 
onwards), hypothesizing that reporting may have changed with the pandemic. We will also 
examine top-box (top-most, e.g., 5 of 5 or excellent, Likert scale) safety climate scores pre- vs 

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post-intervention and proportion of parents reporting “yes definitely”/“yes somewhat” vs “no” to 
the Child HCAHPS “tell you how to report” question.42 A two-sided p-value <.05 will considered 
statistically significant.  
We will also examine hospital voluntary incident reporting to determine the percent of events 
reported via FACES comment card also captured in voluntary incident reporting. 
We will use REDCap (Vanderbilt) for study management and SAS v.9.0 (Cary, NC) for 
analyses. 
9.4.2 Analysis of the Primary Endpoints 
Our primary outcome is family-reported safety concerns, which we define as reporting a safety 
concern via pre-discharge survey (pre- and post-intervention) or FACES comment card (post-
intervention). Safety concerns will be counted once if reported both via survey and comment card. 
Secondary outcomes include safety experience (Child HCAHPS measure) and safety climate 
scores. These endpoints will be analyzed as described above 
 
9.4.3 Analysis of the Secondary Endpoint(s) 
Secondary outcomes include safety experience (Child HCAHPS measure) and safety climate 
scores and will be analyzed as described above. 
9.4.4 Safety Analyses 
N/A 
9.4.5 Baseline Descriptive Statistics 
Baseline descriptive statistics will be collected and analyzed during the pre-intervention study 
period.  
9.4.6 Planned Interim Analyses 
Interim analyses will include (1) a study of baseline (pre-intervention) and (2) a study of qualitative 
interviews results. The first will access rates of safety reporting and safety events in patients 
enrolled in the pre-intervention arm of the study. The second will access qualitative data from 
multiple study stakeholders including but not limited to: parents, physicians, nurses, and hospital 
leaders.  
9.4.7 Sub-Group Analyses 
We expect to analyze data by subgroups including those with lower education (less than college 
degree) and those that speak a language other than English (Spanish-speaking participants).  
9.4.8 Tabulation of individual Participant Data 
N/A 
9.4.9 Exploratory Analyses 
N/A 

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10 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1 INFORMED CONSENT PROCESS 
10.1.1 Consent/Assent Procedures and Documentation 
Families interested in participating will provide verbal consent for enrollment and this will be 
documented. Upon approaching families, study staff will verify that the email addresses and phone 
numbers already collected by the hospital in the medical record are accurate. If an email address 
or phone number is not listed in the medical record, study staff will ask families if they are willing 
to provide their email address and phone numbers. These email addresses and phone numbers will 
be used for interview scheduling, survey administration, consenting purposes (for the instances in 
which parents are not at bedside), and mobile reporting tool participation. If parents choose not to 
or are unable to provide an email address or phone number, the research team will respect such a 
situation and reiterate the other available ways the parent can still participate in the study should 
they choose to. Families will receive information about our study as part of their admission packet. 
10.1.2 Consent for minors when they reach the age of majority  
N/A 
10.1.3 Considerations for Consent of AHRQ staff, or family members of study team 
members 
N/A 
10.1.4 Consent of Participants who are, or become, decisionally impaired 
Adults unable to provide consent are excluded from enrolling in the protocol. However, it is 
possible that participants enrolled in the protocol may permanently lose the capacity to consent for 
themselves during the course of this study.  In the event this occurs, the participants will be 
withdrawn from the study.  
10.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to study participants, 
investigator, funding agency, and regulatory authorities.  If the study is prematurely terminated or 
suspended, the Principal Investigator (PI) will promptly inform study participants, the Institutional 
Review Board (IRB), and sponsor and will provide the reason(s) for the termination or suspension.  
Study participants will be contacted, as applicable, and be informed of changes to study visit 
schedule. 
 Circumstances that may warrant termination or suspension include, but are not limited to: 
 Determination of unexpected, significant, or unacceptable risk to participants 
 Insufficient compliance of study staff to the protocol requirements 
 Data that are not sufficiently complete and/or evaluable 
 Determination that the primary endpoint has been met 
 Determination of futility 

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10.3 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, the safety and oversight monitor(s), and the sponsor(s) and funding agency. This 
confidentiality is extended to the data being collected as part of this study. Data that could be used 
to identify a specific study participant will be held in strict confidence within the research team. 
No personally identifiable information from the study will be released to any unauthorized third 
party without prior written approval of the sponsor/funding agency.  
All research activities will be conducted in as private a setting as possible. 
The study monitor, other authorized representatives of the sponsor or funding agency, 
representatives of the Institutional Review Board (IRB), regulatory agencies or representatives 
from companies or organizations supplying the product, may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site 
will permit access to such records. 
The study participant’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure location 
for as long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding 
agency requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, 
will be transmitted to and stored at Boston Children’s Hospital (BCH). This will not include the 
participant’s contact or identifying information. Rather, individual participants and their research 
data will be identified by a unique study identification number. The study data entry and study 
management systems used by clinical sites and by BCH research staff will be secured and 
password protected. At the end of the study, all study databases will be de-identified and archived 
at BCH. 
10.3.1 Measures Taken to Ensure Confidentiality of Data Shared per the AHRQ Data 
Sharing Policies  
The PI will ensure all mechanisms used to share data will include proper plans and safeguards for 
the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all 
data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans 
for archiving and long-term preservation of the data will be implemented, as appropriate.  
10.3.2 Certificate of Confidentiality  
To further protect the privacy of study participants, the Secretary, Health and Human Services 
(HHS), has issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, 
behavioral, clinical or other human participants research funded wholly or in part by the federal 
government for AHRQ-funded research.  Recipients of AHRQ funding for human participants 
research are required to protect identifiable research information from forced disclosure per the 
terms of the AHRQ Policy. As set forth in 45 CFR Part 75.303(a), recipients conducting AHRQ-
supported research covered by this Policy are required to establish and maintain effective internal 
controls (e.g., policies and procedures) that provide reasonable assurance that the protocol is 
managed in compliance with Federal statutes,  and regulations. 

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10.4 FUTURE USE OF STORED SPECIMENS AND DATA 
N/A 
10.5 SAFETY OVERSIGHT 
N/A 
10.6 CLINICAL MONITORING 
N/A 
10.7 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data collection, 
documentation and completion. All sites will follow a common quality management plan. 
Quality control (QC) procedures will be implemented as follows: 
Informed consent – Study staff will review the documentation of the consenting process.  
Feedback will be provided to the study team to ensure proper consenting procedures are followed.  
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and 
will implement corrective actions when the quantity or nature of deviations are deemed to be at a 
level of concern. 
Should independent monitoring become necessary, the PI will provide direct access to all trial 
related sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
10.8 DATA HANDLING AND RECORD KEEPING 
10.8.1 Data Collection and Management Responsibilities 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision 
of the site investigator. The investigator will be responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported.  
Clinical data (including adverse events (AEs) reported as a primary outcome of the study) will be 
entered into a secure REDCap stored behind the firewall at BCH. The data system includes 
password protection. Clinical data will be entered directly from the source documents. 
10.8.2 Study Records Retention 
In accordance with AHRQ and federal policy, study documents should be retained for a minimum 
of 3 years after the conclusion of enrollment. Per BCH regulations, study records will be retained 
for a minimum of 7 years after conclusion of enrollment. No records will be destroyed without the 
written consent of the sponsor, if applicable. 
10.9 PROTOCOL DEVIATIONS AND NON-COMPLIANCE 
It is the responsibility of the investigator to use continuous vigilance to identify and report 
deviations and/or non-compliance to the BCH Institutional Review Board.  All deviations must be 
addressed in study source documents, reported to the AHRQ Program Official and the BCH IRB.  
The investigator is responsible for knowing and adhering to the reviewing IRB requirements. 

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FACES Protocol 11.13.2023 
A protocol deviation is any changed, divergence, or departure from the IRB-approved research 
protocol.  
 Major deviations: Deviations from the IRB approved protocol that have, or may have the 
potential to, negatively impact the rights, welfare or safety of the participant, or to 
substantially negatively impact the scientific integrity or validity of the study. 
 Minor deviations: Deviations that do not have the potential to negatively impact the rights, 
safety or welfare of participants or others, or the scientific integrity or validity of the study. 
10.10  HUMAN DATA SHARING, INCLUDING GENOMIC DATA SHARING, AND PUBLICATION 
N/A 
10.10.1  AHRQ Data Management and Sharing Policy  
This study will comply with the AHRQ Data Management and Sharing Policy.  
10.11  COLLABORATIVE AGREEMENTS  
10.11.1Agreement Type 
Per AHRQ guidelines, sites participating in this study will rely on a single IRB at the sponsor 
institution. All sites participating in research will have DUA and DTA with the sponsor institution.  
10.12  CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical.  Therefore, any actual conflict of interest of persons who have 
a role in the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and 
managed. Furthermore, persons who have a perceived conflict of interest will be required to have 
such conflicts managed in a way that is appropriate to their participation in the design and conduct 
of this trial.  The study leadership in conjunction with the AHRQ has established policies and 
procedures for all study group members to disclose all conflicts of interest and will establish a 
mechanism for the management of all reported dualities of interest. These conflicts of interest will 
be reported to the BCH IRB.  
11 ABBREVIATIONS 
AE 
Adverse Event 
AHRQ 
Agency for Healthcare Research and Quality 
CFR 
Code of Federal Regulations 
CMC 
Children with Medical Complexity 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
DCC 
Data Coordinating Center 
DSMB 
Data Safety Monitoring Board 
DTA 
Data Transfer Agreement 
DUA 
Data Use Agreement 
FACES Family Activation and Communication about Errors and Safety 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 

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FACES Protocol 11.13.2023 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
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