Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit
Phase: NA
Conditions: Communication, Critical Illness
Sponsor: Children's Hospital of Philadelphia

 
 
Title:  Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit 
 
NCT: ID: 15-012274 
 
Document date: 12/18/2021 
 
 

 
 
 
 
 
 
 
 
ii
 
 
Title: 
Communication Skills Training for Interprofessional Teams in 
the Pediatric Cardiac Intensive Care Unit 
Short Title 
Interprofessional CST 
eIRB Number 
15-012274 
Protocol Date: 
August 26, 2015 
Amendment 50:                December 8th, 2021   
 
 
 
 
Study Principal Investigator 
 
Jennifer K. Walter, MD, PhD, MS 
The Children’s Hospital of Philadelphia 
2716 South St Rm 11-171 
Philadelphia, PA, 19146 
Office: 267-426-7466 
Email: walterj1@email.chop.edu 
 

 
 
 
 
 
 
 
 
iii
TABLE OF CONTENTS 
 
TABLE OF CONTENTS ................................................................................................................................. III 
ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................................................ VI 
ABSTRACT ..................................................................................................................................................... VII 
TABLE 1: SCHEDULE OF STUDY PROCEDURES ................................................................................. IX 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ..................................... 2 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 2 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 6 
2 
STUDY OBJECTIVES .............................................................................................................................. 7 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................ 7 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 7 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 8 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 8 
3.1.1 Enrollment Phase .............................................................................................................................. 10 
3.1.2. 
Co-Design of Intervention Phase .............................................................................................. 11 
3.1.3 
Pre-CST Intervention Phase .......................................................................................................... 13 
3.1.4 
CST Intervention ........................................................................................................................... 13 
3.1.5 
Follow-Up Phase .......................................................................................................................... 13 
3.2 
BLINDING ........................................................................................................................................... 14 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................. 14 
3.3.1 
Duration of Study Participation .................................................................................................... 14 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected ................................................ 15 
3.4 
STUDY POPULATION ........................................................................................................................... 15 
3.4.1 
Participants in Co-design .............................................................................................................. 15 
3.4.2 
Clinicians Participating in Intervention ........................................................................................ 15 
3.4.3 
Clinicians Not Participating in Intervention ................................................................................. 16 
3.4.4 
Parent-patient Dyads Participating in the Survey or Interview .................................................... 16 
4 
STUDY PROCEDURES .......................................................................................................................... 17 
4.1 
ENROLLMENT PHASE .......................................................................................................................... 17 
4.1.1 
Subjects Participating in Co-design: Visit 1 ................................................................................. 17 
4.1.2 
Clinicians Participating in Intervention: Visit 1 ........................................................................... 17 
4.1.3 
Clinicians Not Participating in Intervention: Visit 1 .................................................................... 17 
4.1.4 
Parent-patient Dyads Participating in the Survey Prior to the Intervention: Visit 1 .................... 17 
4.1.5 
Parent-patient Dyads Participating in the Interview Prior to the Intervention: Visit 1 ................ 17 
4.2 
CO-DESIGN OF INTERVENTION PHASE ................................................................................................ 18 
4.2.1 
Subjects Participating in Co-design: Visit 2-12 ............................................................................ 18 
4.3 
PRE-INTERVENTION PHASE ................................................................................................................ 18 
4.3.1 
Clinicians Not Participating in Intervention: Visit 2 .................................................................... 18 
4.3.2 
Parent-patient Dyads Participating in the Survey: Visit 2 ............................................................ 18 
4.4 
INTERVENTION PHASE ........................................................................................................................ 18 
4.4.1 
Clinicians Participating in Intervention: Visit 2-11 ...................................................................... 18 
4.5 
FOLLOW-UP PHASE ............................................................................................................................ 18 
4.5.1 
Clinicians Participating in Intervention: Visit 5-30 ...................................................................... 18 
4.5.2 
Clinicians Participating in Intervention: Visit 6-21 ...................................................................... 19 
4.5.3 
Clinicians Not Participating in Intervention: Visit(s) 2-17 ........................................................... 19 

  
 
 
 
 
 
 
 
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4.5.4 
Parent-patient Dyads Participating after Intervention: Visit 1 ..................................................... 19 
4.5.5 
Parent-patient Dyads Participating after Intervention: Visit 2 ..................................................... 19 
4.5.6 
Parent-patient Dyads Participating after Intervention: Visit 3 ..................................................... 19 
4.5.7 
Parent-patient Dyads Participating after Intervention: Visit 4 ..................................................... 19 
4.6 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................................... 19 
4.6.1 
Early Termination Study Visit ....................................................................................................... 19 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 20 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................ 20 
5.1.1 
Evaluations, Measures .................................................................................................................. 20 
5.2 
EFFICACY EVALUATIONS ................................................................................................................... 25 
5.2.1 
Diagnostic Tests, Scales, Measures, etc. ....................................................................................... 25 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 27 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 27 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 27 
6.3 
STATISTICAL METHODS...................................................................................................................... 29 
6.3.1 
Baseline Data ................................................................................................................................ 29 
6.3.2 
Efficacy Analysis ........................................................................................................................... 30 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 31 
6.5 
INTERIM ANALYSIS ............................................................................................................................ 32 
7 
SAFETY MANAGEMENT ..................................................................................................................... 33 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 33 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 33 
8 
STUDY ADMINISTRATION ................................................................................................................. 34 
8.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 34 
8.1.1 
Blinding .................................................................................................................................... 34 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 34 
8.3 
CONFIDENTIALITY .............................................................................................................................. 36 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 37 
8.4.1 
Data and Safety Monitoring Plan ................................................................................................. 37 
8.4.2 
Risk Assessment ............................................................................................................................. 37 
8.4.3 
Potential Benefits of Trial Participation ....................................................................................... 38 
8.4.4 
Risk-Benefit Assessment ................................................................................................................ 39 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 39 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 40 
8.6.1 
Selecting Family Meetings ............................................................................................................ 42 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ..................................................................................................... 43 
9 
PUBLICATION ........................................................................................................................................ 44 
10 
REFERENCES ......................................................................................................................................... 44 
11 
APPENDIX ................................................................................ ERROR! BOOKMARK NOT DEFINED. 
11.1 
EMAIL TO SUBJECTS TO REQUEST PARTICIPATION IN CO-DESIGN ERROR! BOOKMARK NOT DEFINED. 
11.2 
EMAIL TO CLINICIANS TO REQUEST PARTICIPATION IN INTERVENTION ARM ...... ERROR! BOOKMARK 
NOT DEFINED. 
11.3 
PRE-MEETING AND NEXT STEPS WORKSHEETS FOR FAMILY MEETING ........ ERROR! BOOKMARK NOT 
DEFINED. 
11.4 
INTERVENTION ELEMENTS AND DESCRIPTION OF WORK TO BE DONE WITH CO-DESIGN SUBJECTS
 
ERROR! BOOKMARK NOT DEFINED. 
11.5 
FOCUS GROUP GUIDE FOR CLINICIANS PARTICIPATING IN CO-DESIGN ........ ERROR! BOOKMARK NOT 
DEFINED. 
11.6 
SURVEY ASSESSMENT FOR CLINICIANS PARTICIPATING IN CO-DESIGN ........ ERROR! BOOKMARK NOT 
DEFINED. 

  
 
 
 
 
 
 
 
v
11.7 
EMAIL TO CLINICIANS TO COMPLETE ONLINE SURVEY AFTER CST ............. ERROR! BOOKMARK NOT 
DEFINED. 
11.8 
EMAIL TO CLINICIANS TO PARTICIPATE IN INTERVENTION ACCEPTABILITY INTERVIEW .......... ERROR! 
BOOKMARK NOT DEFINED. 
11.9 
EMAIL TO CLINICIANS TO COMPLETE SURVEY AFTER ACTUAL FAMILY MEETING ................... ERROR! 
BOOKMARK NOT DEFINED. 
11.10 
POST-FAMILY MEETING ONLINE CLINICIAN SURVEY ............... ERROR! BOOKMARK NOT DEFINED. 
11.11 
POST-INTERVENTION SURVEY ................................................. ERROR! BOOKMARK NOT DEFINED. 
11.12 
FIDELITY CHECKLIST FOR IMPLEMENTATION OF INTERVENTION IN ACTUAL FAMILY MEETINGS
 
ERROR! BOOKMARK NOT DEFINED. 
11.13 
INTERVIEW GUIDE FOR CLINICIANS IN THE CICU TO MEASURE INTERVENTION ACCEPTABILITY
 
ERROR! BOOKMARK NOT DEFINED. 
11.14 
PARENT-PATIENT DYAD SURVEY ASSESSMENT PRE-INTERVENTION ....... ERROR! BOOKMARK NOT 
DEFINED. 
WELCOME PAGE ........................................................................................ ERROR! BOOKMARK NOT DEFINED. 
WELCOME TO OUR STUDY! THANK YOU FOR HELPING US BETTER UNDERSTAND YOUR EXPERIENCES OF 
COMMUNICATION WITH THE CLINICAL TEAM IN THE CARDIAC INTENSIVE CARE UNIT. ...... ERROR! BOOKMARK 
NOT DEFINED. 
SECTION 1: IMPACT OF EVENT SCALE-REVISED (IES-R) ........................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 2: TRUST IN PHYSICIAN SCALE ................................................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 3: CONTROL PREFERENCES SCALE FOR PEDIATRICS (CPS-P) ..... ERROR! BOOKMARK NOT DEFINED. 
SECTION 4: COMMUNICATION ASSESSMENT TOOL-TEAM (CAT-T) .......... ERROR! BOOKMARK NOT DEFINED. 
SECTION 5: HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS) .......... ERROR! BOOKMARK NOT DEFINED. 
SECTION 6: MYICU FAMILY MEMBER/SURROGATE VERSION ..................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 7: PEDIATRIC FAMILY SATISFACTION WITH CARE IN THE INTENSIVE CARE UNIT (PFS-ICU 24)
 .................................................................................................................. ERROR! BOOKMARK NOT DEFINED. 
SECTION 8: FAMILY DEMOGRAPHICS ........................................................ ERROR! BOOKMARK NOT DEFINED. 
11.15 
PARENT-PATIENT DYAD SURVEY ASSESSMENT POST-INTERVENTION ..... ERROR! BOOKMARK NOT 
DEFINED. 
WELCOME PAGE ........................................................................................ ERROR! BOOKMARK NOT DEFINED. 
WELCOME TO OUR STUDY! THANK YOU FOR HELPING US BETTER UNDERSTAND YOUR EXPERIENCES OF 
COMMUNICATION WITH THE CLINICAL TEAM IN THE CARDIAC INTENSIVE CARE UNIT. ...... ERROR! BOOKMARK 
NOT DEFINED. 
SECTION 1:  FAMILY MEETING PREPARATION WORKSHEET ...................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 2: CICU FAMILY MEETING SUMMARY ....................................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 3: IMPACT OF EVENT SCALE-REVISED (IES-R) ........................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 4: TRUST IN PHYSICIAN SCALE ................................................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 5: CONTROL PREFERENCES SCALE FOR PEDIATRICS (CPS-P) ..... ERROR! BOOKMARK NOT DEFINED. 
SECTION 6: COMMUNICATION ASSESSMENT TOOL-TEAM (CAT-T) .......... ERROR! BOOKMARK NOT DEFINED. 
SECTION 7: HOSPITAL ANXIETY AND DEPRESSION SCALE (HADS) .......... ERROR! BOOKMARK NOT DEFINED. 
SECTION 8: MYICU FAMILY MEMBER/SURROGATE VERSION ..................... ERROR! BOOKMARK NOT DEFINED. 
SECTION 9: PEDIATRIC FAMILY SATISFACTION WITH CARE IN THE INTENSIVE CARE UNIT (PFS-ICU 24)
 .................................................................................................................. ERROR! BOOKMARK NOT DEFINED. 
SECTION 10: FAMILY DEMOGRAPHICS ...................................................... ERROR! BOOKMARK NOT DEFINED. 
11.16 
PARENT-PATIENT DYAD INTERVIEW GUIDE PRE-INTERVENTION ............. ERROR! BOOKMARK NOT 
DEFINED. 
11.17 
PARENT-PATIENT DYAD INTERVIEW GUIDE POST-INTERVENTION ........... ERROR! BOOKMARK NOT 
DEFINED. 
11.18 
PEDIATRIC CARDIAC CRITICAL CARE CONSORTIUM (PC4) VARIABLES ... ERROR! BOOKMARK NOT 
DEFINED. 
 
 
 

  
 
 
 
 
 
 
 
vi
 
 
 
 
 
 
 
 
 
 
 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AHD 
Advanced Heart Disease 
CAT-T 
Communication Assessment Tool-Team  
CHOP 
Children's Hospital of Philadelphia 
CICU 
Cardiac Intensive Care Unit 
CPS-P 
Control Preferences Scale for Pediatrics 
CSACD 
Collaboration and Satisfaction About Care Decisions 
CST 
Communication Skills Training 
FCC 
Family-centered Care 
HAD 
Hospital Anxiety and Depression Scale 
ICU 
Intensive Care Unit 
IES-R 
Impact of Event Scale-Revised  
IOM 
Institute of Medicine 
IPE 
Interprofessional Education 

 
 
 
 
 
 
 
 
 
 
vii
MIPS 
Medical Interaction Process System 
PC4 
Pediatric Cardiac Critical Care Consortium 
PERCS 
Program to Enhance Relational and Communication Skills 
PFS-ICU 24 Pediatric Family Satisfaction with Care in the Intensive Care Unit 
PPCS 
Pediatric Palliative Care Specialists 
PTSD 
Post-traumatic Stress Disorder 
SDM 
Shared Decision-making 

 
 
 
 
 
 
 
 
 
 
viii
ABSTRACT 
Context: 
A large proportion of children with advanced heart disease (AHD) die in the pediatric 
cardiac intensive care unit (CICU), where parents describe obtaining a realistic 
understanding that their child had a life-limiting disease only 2 days prior to death. Delayed 
or inadequate communication within teams or with families may contribute to this lack of 
understanding (as shown in children with other serious illnesses), while interactions with 
pediatric palliative care specialists (PPCS) have been shown to improve communication and 
understanding of prognosis. The limited number of PPCS, however, means that all clinicians 
in the CICU must have the skills to support parental decision-making, including giving bad 
news and eliciting parental goals for their child. 
Objectives: 
1. To develop a communication skills training (CST) program for interprofessional 
teams in the pediatric CICU via a co-design process.  
2. To evaluate CICU clinicians’ perceived feasibility and acceptability of the CST. 
3. To evaluate CST impact on communication skills and team function in actual family 
meetings. 
4. To learn parents’ perspectives about communication challenges in the CICU. 
5. To determine the parents’ perceived acceptability of the parent-facing aspects of the 
CST program.  
6. Evaluate clinician fidelity to intervention plan.  
Study Design:  
Cohort study with pre and post assessments around an intervention. 
Setting/Participants: 
Clinicians at CHOP and parents of children previously hospitalized in the ICU will be 
invited to participate in the co-design portion of the study. A separate group of volunteer 
attending intensivists, cardiologists, cardiac surgeons, front line clinicians, nurses, and social 
workers from the pediatric CICU at the Children's Hospital of Philadelphia (CHOP) will 
undergo the CST program intervention and participate in observed family meetings. Other 
clinicians who are participating in an observed family meeting will also be enrolled. Parents 
or legal guardians and their children in the CICU who have been there for at least 7 days and 
are expected to stay at least another 7 days will also be consented and enrolled. 
Study Interventions and Measures: 
Intervention: 
The intervention is a CST for a group of interprofessional clinicians that will include 
practice in communication skills of giving bad news and eliciting goals of care and building 
team collaboration. Parental-facing aspects of the intervention include parental preparation 

  
 
 
 
 
 
 
 
ix
for family meetings and provision of written summary of the family meeting after its 
completion.  
Measures: 
The Co-design process to develop the intervention will have focus groups to evaluate the 
interventions’ content and feasibility and a survey to measure participant engagement in the 
focus groups. 
The impact of the CST program on CICU clinicians’ perceived usefulness and satisfaction 
with the training will be measured with a post-CST survey. This survey will also measure 
clinician burnout, demographics and experience with modalities of communication pre and 
during the COVID-19 pandemic.  Furthermore, a random sample of 8 clinicians 
participating in the CST will complete an acceptability interview regarding their thoughts on 
the intervention.  
For the actual family meetings, assessment of the impact of the CST on communication and 
team function in actual family meetings pre and post-CST will be done by coding audio 
recordings using the same tools as in simulated encounters and qualitative coding of content. 
Collaboration will be measured using the amount of time different members of different 
disciplines speak, and team member perception and satisfaction with collaboration will be 
measured using a validated tool. 
Parents’ experiences in family meetings and perspectives on communication with the 
clinical team will be measured with a pre-intervention survey or interview. Parents’ 
acceptability of the parent preparation process for the family meeting and of the written 
summary received after the meeting will be measured during the post-intervention survey 
and interview.  
 

 
x  
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES  
 
Clinicians and Parents Participating in Co-design 
Study Phase 
Enrollment 
Co-design 
Visit Number 
1 
2-12 
Study Days 
1 
2-400 
Enrollment 
X 
 
Get Feedback through Focus Group  
 
X 
Measure Engagement through Survey 
 
X 
 
 
Clincians Participating in Intervention 
Study Phase 
Enrollment 
Intervention 
Follow-up 
Visit Number 
1 
2-11 
5-30 
6-21 
Study Days 
1 
2-200 
9-500 
36-310 
Enrollment 
X 
 
 
 
Communication Skills Training (up to 
10 hours) 
 
X 
 
 
Online course evaluation survey 
including Maslach burnout score and 
COVID-19 questions 
 
X 
 
 
Post-CST actual clinical encounters 
 
 
X 
 
Follow-up actual meeting survey 
 
 
X 
 
Acceptability interview 
 
 
 
X 
 
 

 
xi  
 
 
 
 
 
 
 
Clinicians Not Participating in Intervention 
Study Phase 
Enrollment 
Pre or Post-Intervention 
Visit Number 
1 
2-17 
Study Days 
1 
2-540 
Enrollment 
X 
 
Observed Family Meeting 
 
X 
Online Survey 
 
X 
 
 
 
Parent-patient Dyads Participating in the Survey (Prior to Intervention) 
Study Phase 
Enrollment 
Follow-Up 
Visit Number 
1 
 
Study Days 
1 
2-730 
Enrollment 
X 
 
Online Survey 
                       X 
 
Medical record review (patient or 
family not contacted)  
 
X 
Parent-patient Dyads Participating in the Interview (Prior to Intervention)  
Study Phase 
Enrollment 
Visit Number 
1 
Study Days 
1 
Enrollment 
X 
In-person Interview 
                       X 

 
page xii 
  
 
 
 
 
Parent-patient Dyads Participating in the Survey and Interview (After Intervention) 
Study Phase 
Enrollment 
Follow-Up 
Follow-Up 
Follow-Up 
Follow-Up 
Visit Number 
1 
2 
3 
4 
 
Study Days 
1 
1-10 
1-60 
2-60 
2-730 
Enrollment 
X 
 
 
 
 
Recording of 
Family Meeting 
 
X 
 
 
 
Online Survey 
           
 
X 
 
 
Interview 
 
 
 
X 
 
Medical record 
review (patient 
or family not 
contacted)  
 
 
 
 
X 

 
  
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Parents caring for children with serious illness describe many unmet communication needs. 
Unfortunately, parents often describe the process of making medical decisions for their 
seriously ill child as insufficiently empathetic, lacking in genuine partnership with their 
child’s providers, and reliant upon inadequate and poorly timed information1-5. For many 
families with a seriously ill child, decision-making also occurs against a backdrop of 
heightened parental anxiety6, depression7-9, and stress10. The stress families experience is 
exacerbated by inadequate communication with their family member’s health care 
providers11. Longer stays in the intensive care unit (ICU) are associated with an increased 
likelihood of conflict between families and clinicians4. Parental stress after a child’s 
hospitalization in an ICU is frequently significant enough to meet criteria for post-traumatic 
stress disorder (PTSD)12, and parental distress can persist for months or years after ICU 
discharge12-14. Parents of patients who have died in the ICU are more likely to experience 
complicated grief if they received inadequate information or emotional support from 
providers prior to their child’s death15,16. 
This is especially significant for parents of children with advanced heart disease (AHD). 
Parents of seriously ill children, including children with AHD, must make difficult decisions 
about their child’s care in situations that are emotionally charged and uncertain. The child’s 
chance of recovery may be unclear, and some parents face the possibility that their child 
may die. Parents rely on their child’s provider for guidance and most want to share in 
decision-making17-20. With evidence of missed opportunities of decision-support for 
families, clinicians caring for seriously ill children require evidence-based training in order 
to gain skills in basic palliative care21. 
Basic pediatric palliative care skills are essential for clinicians and clinical teams caring for 
children with AHD22, of whom a large proportion die in the cardiac intensive care unit 
(CICU)23. Parents describe obtaining a realistic understanding that their child had a life-
limiting disease only 2 days prior to death1. Delayed or inadequate communication may 
contribute to this lack of understanding (as shown in children with other serious illnesses)24-
26, while interactions with pediatric palliative care specialists (PPCS) have been shown to 
improve communication and understanding of prognosis27,28. The limited number of PPCS, 
however, means that all clinicians in the CICU must have the skills to support parental 
decision-making, including giving bad news and eliciting parental goals for their child. 
To improve the lives of seriously ill patients and the caregivers making decisions for them, 
there must be evidence-based interventions that provide guidance to clinicians on how to 
effectively communicate with families. Shared decision-making (SDM) has been widely 
recommended to improve communication between clinicians and families. Formal family 
meetings, where several clinicians and multiple family members meet at a planned time to 
discuss treatment plans or goals of care, are often missed opportunities to promote SDM. 
Communication training has been shown to improve physician skills in discussing end of 
life care in simulated patient encounters29-31. Unfortunately, the data showing the impact of 
provider training on patient level outcomes is not clear32-34. There is also limited data on 

 
  
 
 
 
2
how training interprofessional clinical teams in communication in the ICU impacts team 
collaboration35. 
1.2 Name and Description of Investigational Product or Intervention 
The communication skills training (CST) program for clinicians will encourage the use of 
best practices in conducting family meetings where teams give bad news and elicit goals of 
care as well as build team collaboration. The CST will be developed by modifying the 
VitalTalk36 CST to adapt it to interprofessional training, the pediatric CICU setting, and 
CHOP-developed Family Meeting Resources. The family-facing intervention includes 
standardized preparation for family meetings and provides a written summary of the family 
meeting to families.  The combined aspects of the intervention are now known as CICU 
Teams and Loved ones Communicating (CICU TALC).   
1.3 Relevant Literature and Data 
AHD remains a leading cause of non-accidental death for children22, with a large proportion 
of these patients dying in the CICU23. In one study, the majority of parents whose children 
died of AHD believed that their child would have a normal lifespan until only 2 days prior to 
death1. 38% of these parents had considered limitations of interventions before their child’s 
provider raised the issue. 20% of parents never had a discussion about limitations of 
interventions1. When counseling parents of newborns with a hypoplastic left heart, 
cardiologists and surgeons also fail to offer palliative care as an option 40% of the time37. 
This omission is particularly surprising since many of these professionals would prefer a 
palliative approach if faced with making the decision for their own child38. Clinicians’ 
reluctance to offer these choices may be explained by frequently cited barriers to having 
these conversations: lack of training for clinicians, insufficient time, and personal discomfort 
in discussing terminal prognosis21. Evidence-based solutions will be necessary to 
successfully bridge this communication gap that limits parents’ awareness of options for 
their children with AHD.  
Shared decision-making (SDM) has been widely recommended to improve communication 
between clinicians and families. Shared decision-making is a model of provider-patient and 
family communication that has been highlighted by several professional organizations as 
having the potential to bridge this communication gap. SDM requires providers to engage 
with patients and families about treatment options, hear the family’s values and collaborate 
in making decisions39. The American Academy of Pediatrics (AAP) lists SDM as a core 
principle of family-centered care (FCC) along with respecting each child and their diversity, 
building on family strengths while supporting decision-making, and providing support to 
patients throughout their lifespan40. In 2007, based on the Institute of Medicine’s (IOM) 
recommendations41, the American College of Critical Care Medicine encouraged the use of 
SDM in all ICUs42. The recommendations included regular meetings between ICU staff and 
families with full disclosure of prognosis and treatment options, and training to increase 
staff communication and mediation skills42. 
Family meetings are often missed opportunities to consistently meet families’ needs. Formal 
family meetings, where several clinicians and multiple family members meet at a planned 
time to discuss treatment plans or goals of care, have been widely promoted in the ICU to 

 
  
 
 
 
3
operationalize SDM and FCC with some success43-46. Qualitative research has helped 
delineate theoretical frameworks for family meetings and the kind of communication they 
can offer47,48. These frameworks distinguish between information transfer and the emotional 
work or support offered by clinicians, and they underscore the importance of both in 
meetings. Several guides for how best to conduct family meetings have been proposed 
building on clinical expertise and available evidence47,49-51. 
In the few studies about family meetings in the pediatric ICU, clinicians perceived family 
meetings as opportunities to communicate with families and support them52. However, only 
a small percentage of families of patients admitted to the pediatric ICU participated in 
family meetings despite the life-changing decisions that were required of parents; and even 
if family meetings occurred, many were not documented in the medical record53,54.  
Additionally, more careful content analysis of some family meetings identified many missed 
opportunities to listen and respond to families, to acknowledge and address emotions and to 
deploy key principles of palliative care55-57. While family meetings offer the prospect of 
supporting family decision-making, even when they occur, they do not consistently achieve 
their proposed purpose.  
Pediatricians lack training in the basic palliative care skills shown to improve patient and 
family outcomes for seriously ill patients. Palliative care professionals have been called 
upon to ensure SDM is offered to patients in the pediatric ICU58,59 because of their aligned 
commitment to honest, clear communication with the team and families, family-centered 
decision-making, and provision of emotional and spiritual support. Trials have demonstrated 
that interventions with palliative care specialists improve patient and family outcomes for 
adult patients60,61 and satisfaction among pediatric palliative patients28. These findings 
support earlier involvement of PPCS when caring for seriously ill patients.  
While PPCS are an important resource for facilitating more clear and empathetic 
communication, the IOM’s report Dying in America highlights the inadequate transfer of 
palliative care skills to other clinicians caring for pediatric patients with serious illness21. In 
fact, few pediatric trainees are exposed to training in palliative care62-65. This is particularly 
problematic given the insufficient number of PPCS in the United States21,66. As a result, the 
IOM recommends that all clinicians caring for seriously ill patients gain basic palliative care 
skills, including how to communicate about patient and family goals21. Despite recognition 
by pediatric professional organizations of the need for communication training for 
clinicians40,42, sufficient training is still far from being achieved67-71. 
Clinicians can learn basic palliative care communication skills from CST, but it is unclear 
whether CST has an impact on patient and family outcomes. The evidence that clinicians 
can increase their skills and confidence in communication at multiple points in their career is 
robust72-77. Several steps in research of CST have been studied with the goal of eventually 
improving outcomes for patients and families. First, CST can change clinician perception of 
their skills and their confidence in having conversations. The Program to Enhance Relational 
and Communication Skills (PERCS), a pediatric communication training program, has 
demonstrated that participants endorse an improved sense of preparation for difficult 
discussions, increased communication skills, and confidence after completing the training78. 

 
  
 
 
 
4
Boss demonstrated similar findings with a communication training directed toward 
neonatologists79. 
Furthermore, studies of CST can demonstrate an increase in clinician skills in simulated 
encounters. The training program VitalTalk (initially called OncoTalk) has demonstrated 
that resident physicians gain skills in giving bad news and discussing transitions to palliative 
care during simulated encounters. These outcomes were assessed using a coding scheme 
developed for the study that scored audio recordings of simulated clinician-patient 
encounters29.  
Studies of CST can also demonstrate a change in clinician behavior in actual encounters 
with patients and families, not just simulated ones. Fallowfield’s randomized controlled trial 
demonstrated differences in videotaped actual encounters that were coded using the Medical 
Interaction Process System (MIPS) scale80. Subjects reduced their number of leading 
questions and interruptions while increasing the number of open-ended questions and 
expressions of empathy provided74,75. Bonvinci demonstrated an improvement in 
expressions of empathy during outpatient clinical encounters that were audio recorded and 
coded using a Global Rating Scale to measure empathy81.  
Finally, research in CST needs to demonstrate that it impacts patient level outcomes with 
respect to satisfaction, distress, quality of communication, decision-making support or 
reduction in anxiety, PTSD and depression. However, systematic reviews of the literature 
have demonstrated inconclusive evidence that CST has an impact on patient satisfaction, 
distress or quality of life in oncology82,83. Studies outside oncology are also mixed. 
Wilkinson led a positive randomized controlled trial of CST for palliative care nurses 
demonstrating improvement of nurses’ skills in several communication behaviors. In this 
trial, researchers coded audio recordings using the Communication Skills Coverage Rating 
Scale84 and surveyed patients with the Patient Satisfaction with Communication 
Questionnaire74. Patients whose nurses received the intervention were significantly more 
satisfied than those whose nurses had not. Curtis’ randomized trial that trained residents and 
nurse practitioners to assess patient or family outcomes did not demonstrate a difference on 
a Quality of Communication or Quality of End of Life Communication Questionnaire33. For 
this study, surveys were mailed to subjects up to 10 months after the intervention33. Some 
potential limitations to this study were that the surveys were completed months after the 
interaction, and did not reference a particular encounter with the provider, but asked survey 
responders to consider all encounters with the selected provider.  
In order to identify an evidence-based CST that should be disseminated and reimbursed 
more widely, it is necessary to more conclusively demonstrate a connection between training 
and actual patient outcomes. To achieve this goal with adequate confidence in its 
reproducibility, Weiner recommends the development of manualized training programs and 
the consistent use of expert assessment of the communication process using validated coding 
schemes82 and validated patient surveys rating the quality of communication85. 
Interprofessional training in health care can increase team collaboration and communication, 
but its impact on patients and team collaboration has not been sufficiently studied. Clinical 
teams caring for seriously ill patients are comprised of a large number of regularly rotating 
clinicians from a variety of disciplines posing challenges to ensuring reliably high quality 

 
  
 
 
 
5
teamwork and communication within teams86. Optimizing team communication and 
collaboration is essential for patient safety as well as ensuring consistent messaging to 
families about the patient’s care87,88. Leaders of healthcare organizations89,90 recognize the 
benefits of interprofessional team training for promoting better team function, and the IOM 
specifically highlights the need in palliative care21. The IOM defines interprofessional as 
multiple professions working together toward a common goal21. They recommend a mixed-
methods research approach to help close the evidence gap in clearly linking 
interprofessional training to improved health and system outcomes91. 
Both simulation and classroom-based training have been shown to improve teamwork 
processes like communication, cooperation and coordination over extended periods of 
time89. True collaboration of team members also minimizes the hierarchical structures in 
medicine by encouraging team members to listen and anticipate the concerns of other 
disciplines, to take collective responsibility for patient outcomes, and to acknowledge 
collective successes86. 
In the neonatal ICU, nurses perceive a lower level of collaboration than physicians, 
demonstrating a gap that needs to be addressed92. In the adult ICU, when nurses reported a 
higher level of nurse-physician collaboration, patients had better outcomes93. However, a 
prospective intervention in the ICU to improve collaboration, as measured by the Bagg’s 
Collaboration and Satisfaction About Care Decisions (CSACD) scale, did not demonstrate 
significant effects94. Other interprofessional trainings or focus groups have demonstrated 
increases in perception of team collaboration by different members95,96. A small number of 
interprofessional trainings have already been developed to train clinicians in conducting 
family meetings97 and to improve family outcomes in the ICU35,98, but none have also 
measured team collaboration. To ensure that interprofessional CST training impacts team 
collaboration and function, these outcomes must be measured independently.  
Another gap in the literature pertains to creating evidence-based CST in the pediatric setting. 
Because decision-making by parents for their children is different than the experience of 
surrogates making decisions for previously competent adults, communication about 
pediatric patients also requires a focus on family system functioning in addition to goals or 
desires of patients themselves59. Psychological outcomes of parents are tied to their 
perception of being supported by clinicians, family and friends. How parents shift their goals 
for their child is distinct from the shift experienced by surrogates making decisions for 
previously competent adult patients99-101. Parents often describe having a duty to be a good 
parent to their child, and their understanding of this role is central to their decision-
making102. Therefore, successful interventions that have worked in the adult patient realm 
still need to be adapted and tested accordingly for pediatric ICU settings. Even within the 
pediatric ICU world, distinct subcultures exist in cardiac intensive care versus pediatric 
intensive care and neonatology fields, with both unique and overlapping needs.  
To address these critical gaps in our understanding of the impact of interprofessional CST 
on family outcomes in the pediatric CICU, we will evaluate the impact of an adapted CST 
on both simulated and actual patient encounters to evaluate CST’s effect on families of 
patients in the CICU and team function in multiple settings. 

 
  
 
 
 
6
1.4 Compliance Statement 
This study will be conducted in full accordance with all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46 and the Good Clinical Practice: Consolidated Guideline 
approved by the International Conference on Harmonisation (ICH). All episodes of 
noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
 
 

 
  
 
 
 
7
2 
STUDY OBJECTIVES 
The purpose of the study is to assess the impact of a modified communication skills training 
(CST) program to change clinician behavior in family meetings for patients with AHD in the 
pediatric CICU. 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to develop a communication skills training (CST) 
program for interprofessional teams in the pediatric CICU. 
2.2 Secondary Objectives (or Aim) 
The secondary objectives are to: 
• Evaluate CICU clinicians’ perceived feasibility and acceptability with the CST 
• Evaluate CST impact on communication skills and team function in the actual family 
meeting 
• Evaluate clinicians’ burnout rates and changes that CICU clinicians have 
implemented regarding family meetings due to the 2020 COVID-19 pandemic 
• Evaluate the fidelity of clinician behavior to the intended intervention 
• Learn about parents perspectives about communication challenge 
• Learn about parental acceptability about parent-facing intervention elements 
including preparation for family meetings in the CICU and the written summary 
received after the family meeting 
The following secondary endpoints will be used to assess CICU clinicians’ perceived 
feasibility and acceptability with CST: 
• Perceived acceptability of CST 
• Metrics of enrollment rates and missing data 
• Post-CST clinician survey 
• Acceptability interview carried out with randomized subset of 8 intervention 
participants. 
The following secondary endpoints will be used to assess CST impact on clinician behavior 
in simulated family meetings: 
• Communication skill acquisition 
• Team collaboration 
The following secondary endpoints will be used to assess CICU clinicians’ burnout rate and 
changes that CICU clinicians have implemented regarding family meetings due to the 2020 
COVID-19 pandemic: 
• Maslach burnout score103 
• COVID change in practice survey 

 
  
 
 
 
8
The following secondary endpoints will be used to assess CST impact on clinician behavior 
in actual family meetings: 
• Communication skill acquisition 
• Team collaboration 
• Team member perception and satisfaction with collaboration 
• Fidelity of clinician behavior to intervention 
The following secondary endpoints will be used to assess parents’ perspectives about 
communication challenges in the CICU: 
• Satisfaction feelings when communicating with the clinical team with decision-
making 
• Understanding of patient’s medical condition 
• Trust in medical team 
• Levels of anxiety, depression, and post-traumatic stress 
The following secondary endpoints will be used to assess parents’ acceptability of the 
parent-facing elements of the intervention; including preparing for the meeting and their 
perception of the written summary after the family meeting 
• A survey on the experiences and acceptability of using the Family Meeting 
Worksheet, as well as survey questions about their acceptability of the Family 
Meeting Summary Worksheet 
 
The following secondary endpoint will be used to assess co-design participant engagement 
in the co-design process 
• Engagement in co-design  
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This is a non-randomized cohort study with pre and post assessments around an 
intervention. 
Clinicians and Parents Participating in Co-design of Intervention 
Eligible clinicians will be approached in person and via email. If they express willingness to 
participate in the co-design portion of the study, they will be consented. Eligible parents of 
children previously hospitalized in an ICU will be approached via email or phone.  If they 
express willingness to participate in the co-design process, they will be consented.  After 
enrollment into the study, clinicians and parents will participate in a total of 11 sessions as 
focus groups to gather feedback on the CST program. Participants will be asked which 
aspects of the training they believe would facilitate their participation in a family meeting 
and sense of collaboration, which opportunities might have been missed and whether the 
training addressed the core competencies in collaboration. After the 11 sessions have been 
completed, participants will then be asked to complete a survey measuring their engagement 

 
  
 
 
 
9
in the co-design process. Based on participant experience and feedback in the co-design 
sessions, the training will be modified to ensure its goals are met. 
Clinicians Participating in Intervention 
Clinicians in the CICU eligible for the intervention will be approached via email and in 
administrative meetings and individually consented at the beginning of the study.  
After the consent process, clinicians will go through the interprofessional CST. The CST 
will occur over the course of 10 hours and will include short didactic sessions around giving 
bad news, eliciting parental goals, the core competencies of interprofessional collaborative 
practice88, and adaptation for the CICU of the common components of a family meeting as 
represented in the CHOP Family Meeting Resources 
(http://intranet.chop.edu/sites/social_work/family-meeting-resources.html). Skills practice 
groups will include no more than 6 learners at a time.  Didactic sessions may be in person or 
may be performed independently online as needed. Whether in-person or online, sessions 
may be audio or video recorded. There will be an online survey immediately after the CST 
to evaluate the clinicians’ perception of effectiveness of the course. One month after the 
completion of the CST, a random sample of 8 participants will take part in a 15-30 minute 
acceptability interview regarding the CST.  
Following the CST, a set of at least 23 actual family meeting encounters with trained 
clinicians will be audio recorded and coded.  
A measure of team function will be assessed pre and post-CST by comparing the amount of 
time different members of the clinical team speak, and the kind of input offered by members 
of different disciplines within the team for simulated and actual family meetings. Team 
member perception and satisfaction with collaboration will be measured after their 
participation in clinical encounters both pre and post-CST by administering the modified 
Baggs CSACD-N tool to all clinician team members who participate in an actual encounter. 
This tool will capture each discipline’s experience with collaboration with other team 
members and satisfaction with care decisions. Finally, fidelity of clinician behavior to the 
intended intervention in post-intervention family meetings will be determined by a fidelity 
checklist. 
Actual meetings will each last 30-120 minutes. Clinicians participating in the intervention 
will be enrolled for the entirety of the study, lasting up to four years. They will have at least 
21 points of contact with the research team, but some clinicians may participate more 
frequently due to the unknown composition of the observed actual family meetings. 
Clinicians Not Participating in Intervention 
Clinician team members participating in an observed family meeting who will not undergo 
the CST (because they were not eligible, did not wish to participate in the study, or were not 
approached because sufficient clinicians were already enrolled) will be consented before the 
scheduled meeting to being audio or video recorded only in the observed family meeting. 
They will also be administered a survey at the end of the meeting. Clinicians not 
participating in the intervention will be enrolled for only the duration of their observed 
family meeting and may be enrolled more than one time during the course of the study. 

 
  
 
 
 
10
Parent-patient Dyads Participating in the Survey or Interview Prior to Intervention 
Potential subjects will be screened using the protocol inclusion and exclusion criteria. 
Parent-patient dyads will be recruited into the study in person or over the phone. The goal 
for enrollment will be 100 parent-patient dyads for the survey and up to 30 parent-patient 
dyads for the interview. 100 parent-patient dyads who are enrolled will be given an online 
survey on a laptop computer or via email to obtain baseline data assessing parental 
satisfaction, understanding, trust in the clinical team and emotional well-being. Medical 
record review of this group of patients will utilize EPIC and the PC4 database, but will not 
require patient or parent involvement. 30 enrolled parent-patient dyads will participate in an 
interview assessing their experiences in family meetings and their perspectives on 
communication with the clinical team. 
Parent-patient Dyads Participating in the Survey or Interview After Intervention 
Potential subjects will be screened using the protocol inclusion and exclusion criteria. 
Parent-patient dyads will be recruited into the study in person, over the phone, or via e-mail. 
The goal for enrollment will be up to 50 parent-patient dyads, with 30 evaluable parent-
patient dyads. Parent-patient dyads who are enrolled in the post-intervention follow-up 
phase will be asked for access to information entered into the REDCap based Family 
Meeting Worksheet if they choose to use it, will be given an online survey in person or via 
e-mail to obtain post-intervention data assessing parental satisfaction, understanding, trust in 
the clinical team, emotional well-being and parents’ acceptability of the parent-facing 
elements of the intervention, which includes preparation for the meeting and their perception 
of the written summary after the family meeting. Medical record review of this group of 
parents will utilize EPIC and the PC4 database, but will not require patient or parent 
involvement. A subset of enrolled patient-parent dyads will also be invited to participate in 
an interview assessing parents’ acceptability of the parent-facing elements of the 
intervention.  
3.1.1 Enrollment Phase 
Clinicians and Parents Participating in Co-design of the intervention 
Potential clinician subjects and parents of previously hospitalized patients will be screened 
using the protocol inclusion and exclusion criteria. Clinicians will be recruited into the study 
through an open announcement of the study by the study team at faculty meetings and via a 
faculty listserv that will give them contact information to follow up with a study team 
member if they are interested in participating (See Appendix 11.1 for recruitment email). 
Approximately 15 clinicians will be enrolled for the co-design.  Parents will be approached 
via a Family Advisory Council invitation and email listserve call.  Approximately 5 parents 
of previous patients who have been admitted to the ICU will be enrolled.   
Clinicians Participating in Intervention 
Potential clinician subjects will be screened using the protocol inclusion and exclusion 
criteria. CICU clinicians will be recruited into the study through an open announcement of 
the study by the study team at faculty meetings and via a faculty listserv that will give them 
contact information to follow up with a study team member if they are interested in 

 
  
 
 
 
11
participating (See Appendix 11.2 for recruitment email). The goal for enrollment will be at 
least 20 CICU clinicians.  
Clinicians Not Participating in Intervention 
Clinician team members participating in an observed family meeting who will not undergo 
the CST (because they were not eligible, did not wish to participate in the study, or were not 
approached because sufficient clinicians were already enrolled) will be consented to being 
audio or video recorded and completing a survey before the scheduled family meeting. 
Parent-patient Dyads Participating Prior to Intervention 
Potential subjects will be screened using the protocol inclusion and exclusion criteria. 
Parent-patient dyads will be recruited into the study in person or over the phone. The goal 
for enrollment will be up to 100 parent-patient dyads for the survey and up to 30 parent-
patient dyads for the interview. Up to 100 parent-patient dyads who are enrolled will be 
given an online survey on a laptop computer or via email to obtain baseline data assessing 
parental satisfaction, understanding, trust in the clinical team and emotional well-being. 
Medical record review of this group of patients will utilize EPIC and the PC4 database, but 
will not require patient or parent involvement. 30 enrolled parent-patient dyads will 
participate in an interview assessing their experiences in family meetings and their 
perspectives on communication with the clinical team. 
3.1.2. Co-Design of Intervention Phase 
Instead of a pilot, we will conduct a co-design of the intervention with relevant stakeholders 
of the intervention.  Experienced based co-design encourages collaborative work between 
vulnerable patients, their parent caregivers, and staff in complex healthcare environments104, 
allowing for the specific needs of participants to be addressed and included in the adaptation 
of the intervention.105 The co-design process itself impacts clinical practice due to changes 
in clinician behavior after participation in the co-design.106 The process usually takes 9-12 
months to complete and has been described as a 6 stage process: 1) setting up the project, 2) 
gathering staff experiences through observation and in-depth interviews, 3) gathering patient 
and caregiver experiences through narrative based interviews, 4) bringing staff, patients and 
caregivers together to share experiences of the service and shared priorities for 
improvement, 5) small groups of caregivers and staff working on the identified priorities, 
and 6) celebrating and reviewing the event.104 
The CST elements that will be evaluated by the co-design group will be largely modeled 
after the VitalTalk CST training for the ICU, named Critical Care Communication.107  We 
will discuss the acceptability of modification of  the VitalTalk CST in three ways: 1) The 
intervention might focus on interprofessional training rather than singularly on one 
profession (i.e., physicians). Exercises may be designed specifically to require teamwork in 
communication, highlighting the complementary skill sets of different team members. 
Collaboration will be emphasized and didactics will review core competencies as described 
by the Interprofessional Education Collaborative.88 2) The training may be adapted for a 
pediatric CICU setting while preserving several of the learning goals previously tested. We 
will work with Dr. Bob Arnold and pediatric CICU attending, Dr. Aaron Dewitt, MD, to 
develop cases that are clinically accurate and relevant to having clinicians acquire 

 
  
 
 
 
12
previously described learning goals (giving bad news and eliciting parental goals for their 
child).29  3) The training will integrate the CHOP-developed Family Meeting Resources, 
including a pre-meeting worksheet to be filled out by clinicians prior to a family meeting, an 
outline for how to conduct a standard family meeting, and a Next Steps Worksheet to make 
clear what occurred in the meeting and what to expect moving forward. [See Appendix 11.3] 
The pre-meeting worksheet prompts clinicians to articulate the goals of the meeting, 
anticipate challenges, and identify who will be present and lead the meeting. The outline for 
a standard family meeting was developed by compiling the best evidence for how to conduct 
a family meeting.47,50,51,108,109 
The CST will be conducted over a total of 10 hours and will include short didactic sessions 
around giving bad news, eliciting parental goals, the core competencies of interprofessional 
collaborative practice, and the common components of a family meeting. Participating 
clinicians will be provided cognitive road maps for communication tasks that were based on 
empirical studies of patient preferences. Didactics will also emphasize how members of 
different disciplines make important contributions to discussions with families. The majority 
of the time will be spent on skills practice using the VitalTalk model of building on learner’s 
strengths and creating a safe environment for learning new skills, facilitated by myself or 
another VitalTalk trained facilitator. Skills practice groups will include no more than 6 
learners at a time. Because the VitalTalk methodology relies upon well-trained actors to play 
the role of patients and family members for facilitated skills practice by clinician learners, 
we will train actors currently working as actors for CHOP’s Vital Talk program. To 
successfully engage with actor parents and clinicians, teams will need to function 
collaboratively, drawing upon unique knowledge that each team member will be provided 
about the case and family. Actors will not participate in human subjects research and will 
merely perform a service for the study.    
A more complete outline of the CST and how it will be discussed with the co-design group 
is described below in the Appendix 11.4. 
Clinicians will participate in focus groups to gather feedback on the CST program 
throughout the co-design process. Participants will be asked which aspects of the training 
might facilitate their participation in a family meeting and sense of collaboration, which 
opportunities might have been missed, and whether the training addresses the core 
competencies in collaboration. Based on participant feedback, the training will be modified 
to ensure its goals are met.  
After the completion of all focus group sessions, participants will be asked to complete a 
short survey. The survey is a modified version of a validated tool that allows for analysis by 
subscale.110-112 The subscales used in the Co-design survey are a 14-item section measuring 
participants’ perceptions of the Co-design leader’s effectiveness and a 10-item section 
measuring participants’ perceptions of their own involvement and commitment to the Co-
design process. This information is supplemented with demographic information.  
A more complete outline of the focus group is described below in the Appendix 11.5. The 
survey tool appears in Appendix 11.6. 

 
  
 
 
 
13
3.1.3 Pre-CST Intervention Phase 
Clinicians Not Participating in Intervention: Consented clinicians not participating in the 
intervention will be audio recorded in their previously scheduled family meetings. Clinicians 
not participating in the intervention will complete an online survey after the actual family 
meeting that they are observed participating in. 
3.1.4 CST Intervention 
After the pre-intervention phase, clinicians participating in the intervention will go through 
the interprofessional CST. The CST will occur over the course of 10 hours and will include 
short didactic sessions around giving bad news, eliciting parental goals, the core 
competencies of interprofessional collaborative practice, and the common components of a 
family meeting. Didactic sessions may be in person or may be performed independently 
online as needed. Whether in-person or online, sessions may be audio or video recorded. 
Clinicians must complete all parts of the CST training in order to continue to be enrolled in 
the study. Supplemental handouts that will be used in the training are available in Appendix 
11.3. After completion of the intervention, clinicians who participate in the training will be 
given a course evaluation to determine clinicians’ perception of the usefulness and 
satisfaction with CST. They will be asked to rate their level of agreement with aspects of the 
course on a 5 point Likert-type scale. Post-intervention survey will also include clinician 
burnout measures, demographics, and changes in family meeting communication since the 
onset of the COVID-19 pandemic.  One month after completion of the CST training, a 
random sample of 8 participating clinicians will complete a 15-30 minute acceptability 
interview regarding the CST training. 
3.1.5 Follow-Up Phase 
Clinicians Participating in Intervention: After CST, a set of actual family meeting 
encounters with these trained clinicians will be audio recorded and coded, ensuring there are 
23 meetings with each category of person trained. We estimate a total of 28 meetings will 
need to be recorded in order to obtain 23 meetings with each discipline. Clinicians 
participating in the intervention will complete an online survey after the actual family 
meeting that they are observed participating in. 
This survey will measure team member perception and satisfaction with collaboration. We 
will administer the modified Baggs CSACD-N tool to all clinician team members who 
participate in an actual encounter, which will capture each discipline’s experience with 
collaboration with other team members and satisfaction with care decisions. 
Clinicians Not Participating in Intervention: Consented non-participating clinicians will 
have their normal, scheduled family meetings. Actual family meeting encounters with these 
clinicians will be audio or video recorded and coded. Clinicians not participating in the 
intervention will complete the same online survey as those clinicians participating in the 
intervention after the observed actual family meeting.  
Parent-patient Dyads Participating in the Survey or Interview After Intervention: 
Potential subjects will be screened using the protocol inclusion and exclusion criteria. 
Parent-patient dyads will be recruited into the study in person, over the phone, or via e-mail. 
The goal for enrollment will be up to 50 parent-patient dyads, with 30 evaluable parent-

 
  
 
 
 
14
patient dyads. Parent-patient dyads who are enrolled in the post-intervention follow-up 
phase will be asked for access to information entered into the REDCap based Family 
Meeting Worksheet if they choose to use it, will be given an online survey in person or via 
e-mail to obtain post-intervention data assessing parental satisfaction, understanding, trust in 
the clinical team, emotional well-being and parents’ acceptability of the parent-facing 
elements of the intervention, which includes preparation for the meeting and their perception 
of the written summary after the family meeting. Medical record review of this group of 
parents will utilize EPIC and the PC4 database, but will not require patient or parent 
involvement. A subset of enrolled patient-parent dyads will also be invited to participate in 
an interview assessing parents’ acceptability of the parent-facing elements of the 
intervention.  
3.2 Blinding 
The study will not be blinded given the differences in recording prior to and after the 
COVID pandemic. 
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
Study duration for clinicians and parents participating in the co-design is expected to last up 
to 12 months since their schedules are not conducive to completing the tasks more 
efficiently.  The expectation is that they will meet approximately one hour a month for 11 
months.  
Study duration for clinicians participating in the intervention is expected to last up to 4 
years. The CST intervention will occur over the course of 10 hours lasting over several 
months. Clinicians will have at least 21 points of contact with the research team, but some 
clinicians may participate more frequently due to the unknown composition of the observed 
actual family meetings. 
For each post-family meeting survey administration, clinicians will be contacted no more 
than 3 times via email to request that they complete the survey. Templates for the emails 
requesting that they complete the surveys are demonstrated in Appendix 11.6 and Appendix 
11.7. The surveys are expected to take approximately 5-10 minutes to complete. The full 
survey is located in Appendix 11.10. 
Study duration for non-participating clinicians will last the duration of their family meeting 
(30-90 minutes), and post-meeting surveys are expected to take approximately 5-10 minutes 
to complete. 
Study duration for parent–patient dyads participating prior to the intervention will last 
approximately 20 minutes for those participating in the survey for visit 1 and  their medical 
record review will occur at discharge from the hospital which may range from 2-730 days 
after enrollment.  Study duration will be 30-60 minutes for those participating in the 
interview.   
Study duration for parent-patient dyads participating after the intervention will last 
approximately 30-60 minutes for the recording of the family meeting for visit 2, 20 minutes 

 
  
 
 
 
15
for those participating in the survey for visit 3, and approximately 20 minutes for those 
participating in the interview for visit 4. Medical record review will occur at discharge from 
the hospital which may range from 2-730 days after enrollment.  
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted within the Children’s Hospital of Philadelphia. The co-design 
phase will be conducted with participants from units within the hospital and parents with 
children who had previously been hospitalized at CHOP, and the intervention and evaluation 
of the intervention will occur exclusively in the CICU at CHOP. 
For clinicians participating in the co-design, approximately 15 clinician staff will be enrolled 
and 5 parents will be enrolled.  
For clinician subjects participating in the intervention, recruitment will stop when at least 20 
CICU clinicians are enrolled. 
For non-participating clinicians, recruitment will stop when we obtain at least 56 family 
meetings per discipline of participating clinician team member.  
We estimate that approximately 300 clinicians who are not participating in the intervention 
may be observed subjects in the actual meetings. 
For parent-patient dyads participating prior to the intervention, recruitment will stop when 
100 evaluable parent-patient dyads are enrolled for the survey and 30 evaluable parent-
patient dyads are enrolled for the interview. 
For parent-patient dyads participating after the intervention, recruitment will stop when up 
to 30 evaluable parent-patient dyads are enrolled for the survey and a subset of up to 15 
parent-patient dyads will be asked to participate in the interview. 
3.4 Study Population 
3.4.1 Participants in Co-design 
3.4.1.1 Inclusion Criteria 
• Clinicians including attending physicians, front line clinicians (fellows, nurse 
practitioners, or physician assistants), bedside nurses, and social workers working at 
CHOP or parents of children previously hospitalized in an ICU at CHOP.  
3.4.1.2 Exclusion Criteria 
• None 
3.4.2 Clinicians Participating in Intervention 
3.4.2.1 Inclusion Criteria 
• Pediatric CICU clinicians (attending intensivists, cardiologists, cardiac surgeons, 
front line clinicians,  nurses, and social workers) at CHOP who volunteer to undergo 
communication skills training. 

 
  
 
 
 
16
3.4.2.2 Exclusion Criteria 
• Clinicians who will not participate in CHOP’s CICU chronic care meeting in the 
following year. 
 
3.4.3 Clinicians Not Participating in Intervention 
3.4.3.1 Inclusion Criteria 
• Clinicians who plan to participate in family meetings in the pediatric CICU that will 
be observed by the research team. 
3.4.3.2 Exclusion Criteria 
• None 
3.4.4 Parent-patient Dyads Participating in the Survey or Interview Pre-Intervention 
Phase 
3.4.4.1 Inclusion Criteria 
• Parent must be the legal decision maker of a patient who has been admitted to the 
CHOP CICU for at least 7 days 
• Patient has been admitted to the CICU at CHOP for ≥7 days following onset of study 
and the medical team believes the patient will remain in the CICU for at least 7 more 
days 
• Parent/guardian ≥ 18 years old 
• Child < 18 years old at time of enrollment 
• Parent/guardian is English-speaking 
• Parent/guardian has no cognitive impairments that prevent them from being a 
surrogate decision maker 
3.4.4.2 Exclusion Criteria 
• Parent is not the legal decision maker of a patient who has been admitted to the 
CHOP CICU for at least 7 days 
• The medical team does not believe the patient will remain in the CICU for at least 7 
more days 
• Parent/guardian < 18 years old 
• Child is ≥ 18 years old at time of enrollment 
• Parent/guardian is not English-speaking 
• Parent/guardian has cognitive impairments that prevent them from being a surrogate 
decision maker 
3.4.5 Parent-patient Dyads Participating in the Survey or Interview Post-
Intervention 
3.4.5.1 Inclusion Criteria 
• Parent must be the legal decision maker of a patient who has been admitted to the 
CHOP CICU for at least 7 days 

 
  
 
 
 
17
• Patient has been admitted to the CICU at CHOP for ≥7 days following onset of 
study and the medical team believes the patient will remain in the CICU for at 
least 7 more days OR the patient has already been admitted to the CICU 14 days 
• Parent/guardian ≥ 18 years old 
• Child < 18 years old at time of enrollment 
• Parent/guardian is English-speaking 
3.4.5.2 Exclusion Criteria 
• Parent is not the legal decision maker of a patient who has been admitted to the 
CHOP CICU for at least 7 days 
• Parent/guardian < 18 years old 
• Child is ≥ 18 years old at time of enrollment 
• Parent/guardian is not English-speaking 
 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
 
4 
STUDY PROCEDURES 
4.1 Enrollment Phase 
4.1.1 Subjects Participating in Co-design: Visit 1 
• Eligibility determined for clinician and parent subjects 
• Written or eConsent obtained 
4.1.2 Clinicians Participating in Intervention: Visit 1 
• Eligibility determined for clinician subjects 
• Written or eConsent obtained  
4.1.3 Clinicians Not Participating in Intervention: Visit 1 
• Eligibility determined for non-participating clinicians 
• Written or email consent obtained  
4.1.4 Parent-patient Dyads Participating in the Survey Prior to the Intervention: 
Visit 1 
• Eligibility determined for parent-patient dyads 
• Informed consent obtained in person or via phone 
• Administration of online baseline survey about parental satisfaction, understanding, 
decision-making preferences, trust, and emotional well-being 
4.1.5 Parent-patient Dyads Participating in the Interview Prior to the Intervention: 
Visit 1 
• Eligibility determined for parent-patient dyads 

 
  
 
 
 
18
• Informed consent obtained in person or via phone 
• Administration of in-person interview regarding parental experiences in family 
meetings and perspectives about communication with the clinical team 
4.2 Co-design of Intervention Phase 
4.2.1 Subjects Participating in Co-design: Visit 2-12 
• Clinicians and parents undergo focus groups about the proposed communication 
skills training program and an engagement survey (details of the CST are provided in 
Appendix 11.4) 
4.3 Pre-Intervention Phase 
Before clinicians that are participating in the intervention are trained, their communication 
and team function skills will be assessed in actual encounters. Actual encounters with 
parents and patients will involve participating clinicians and non-participating clinicians. 
4.3.1 Clinicians Not Participating in Intervention: Visit 2 
• Non-intervention participating clinicians recorded during family meeting 
• Administration of online baseline survey about clinicians’ perception of team 
function 
4.3.2 Parent-patient Dyads Participating in the Survey: Visit 2 
• Medical record review.  No parents will be contacted 
4.4 Intervention Phase 
• Participating clinicians will undergo the communication skills training program. 
4.4.1 Clinicians Participating in Intervention: Visit 2-11 
• Administration of CST program over the course of 10 hours. Sessions may be audio 
or video recorded.  
• Administration of online course evaluation survey, burnout scale, demographics, and 
communication in family meetings since COVID-19 pandemic  
4.5 Follow-Up Phase 
After clinicians who participate in the intervention are trained, their communication and 
team function skills will be assessed in actual encounters. Actual encounters with parents 
and patients will involve participating clinicians and non-participating clinicians. 
4.5.1 Clinicians Participating in Intervention: Visit 5-30 
• Clinician audio recorded during actual family meeting 
• Administration of follow-up online survey about clinicians’ perception of team 
function in person or via email 

 
  
 
 
 
19
4.5.2 Clinicians Participating in Intervention: Visit 6-21 
• Administration of 15-30 minute acceptability interview to each of 8 randomly 
sampled clinicians 
4.5.3 Clinicians Not Participating in Intervention: Visit(s) 2-17 
• Non-participating clinician recorded during family meeting 
• Administration of follow-up online survey about clinicians’ perception of team 
function 
4.5.4 Parent-patient Dyads Participating after Intervention: Visit 1 
• Eligibility determined for parent-patient dyads 
• Informed consent obtained in person, via phone, or by eConsent 
• Patient medical record review 
4.5.5 Parent-patient Dyads Participating after Intervention: Visit 2 
• Recording of family meeting 
4.5.6 Parent-patient Dyads Participating after Intervention: Visit 3 
• Administration of online survey about parental satisfaction, understanding, decision-
making preferences, trust, emotional well-being, use and acceptability of Family 
Meeting Preparation Worksheet, and acceptability of Family Meeting Summary 
Worksheet. 
4.5.7 Parent-patient Dyads Participating after Intervention: Visit 4 
• Administration of an interview in-person, by phone or over CHOP secure video 
channel regarding the acceptability of parent preparation for the family meeting 
process and of the written summary received after the meeting. 
4.6 Subject Completion/Withdrawal 
Clinicians, parents, and parent-patient dyads may withdraw from the study at any time 
without prejudice to their employment status or the care of their child at The Children's 
Hospital of Philadelphia. It will be documented whether or not each clinician and parent-
patient dyad completes the study. The Investigator may also withdraw subjects who violate 
the study plan or to protect the subject for reasons of safety or for administrative reasons. 
4.6.1 Early Termination Study Visit 
During any of the visits, if any subject decides to withdraw prior to completion of all study 
materials, the research team will review the individual circumstances and decide whether 
any data already collected will be included in further analyses. These decisions will be based 
on whether enough data has been collected to adequately complete our planned analysis. If 
at any time any subject requests to have information they have submitted withdrawn from 
consideration, we will abide by their request and remove that data from our research 
database.   

 
  
 
 
 
20
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Evaluations, Measures 
Measures for Co-Design 
• Follow-Up focus group (See Appendix 11.5 for focus group guide) 
• Post-focus group survey (See Appendix 11.6 for survey) 
o Demographics of co-design participants: The following baseline data will be 
collected: role in the co-design, gender, race, and ethnicity. 
o Perception of co-design process and level of engagement: Modified version 
of “Coalition Effectiveness Inventory”110-112 that consists of one 14-item 
section measuring participants’ perceptions of the Co-design leader’s 
effectiveness and one 10-item section measuring participants’ perceptions of 
their own involvement and commitment to the Co-design process. 
Measures for Post-Intervention 
• Course Evaluation - Satisfaction with CST and perception of skill usefulness: This 
course evaluation is designed to determine clinicians’ perception of usefulness and 
satisfaction with the CST program. They will be asked to rate their level of 
agreement with aspects of the course on a 5 point Likert-type scale. Furthermore, the 
current burnout rate of clinicians will be assessed using the Maslach burnout 
score.103 Additionally, changes that CICU clinicians have implementedregarding 
family meetings due to the 2020 COVID-19 pandemic will be recorded. Finally, 
clinician demographics will be collected including role in CICU, gender, race, and 
ethnicity. See Appendix 11.11 for complete course evaluation, Maslach burnout 
score, and COVID Change in Practice survey 
• Intervention fidelity checklist: The Fidelity Checklist is a list of 7 behaviors of 
clinicians used to determine if clinicians used the tools and documents taught in the 
intervention. See Appendix 11.12 for the Intervention Fidelity Checklist 
• Acceptability Interview - 1 month follow-up: We will do a semi-structured interview 
with clinicians reviewing their experience of the intervention process including what 
worked well and what they would recommend changing.  Emphasis will be placed 
on virtual aspects of the training given the novelty of the implementation due to the 
COVID-19 pandemic.  The semi-structured interview guide is in Appendix 11.13 
 
Surveys for Clinicians Participating in Actual Family Meetings 
• Demographics of clinician participants: The following data will be collected 
regarding clinician subjects: discipline, age, gender, ethnicity, race, number of years 
in practice, estimated number of family meetings conducted in a week, estimated 
average time spent on conducting family meetings, previous experience with 
communication skills training. 

 
  
 
 
 
21
• Team member perception and satisfaction with collaboration: The Baggs CSACD-N 
tool94,109 will measure team member perception and satisfaction with collaboration 
both pre and post-CST. Clinicians will rate their level of agreement for 9 items on a 
7-point Likert-type scale from “Strongly disagree” to “Strongly agree.” This tool will 
capture each discipline’s experience with collaboration with other team members and 
satisfaction with care decisions. 
Survey Measures for Parent-patient Dyads 
• Demographics of parent-patient dyads: The following baseline data will be collected 
regarding parent-patient dyads: age, gender, ethnicity, race, education level, and 
health literacy. 
• Parental preference for decision making control: The Control Preferences Scale for 
Pediatrics (CPS-P)113 is a 5-item sorting measure of parent preferences for 
participation in treatment decision making. 
• Parental anxiety and depression: The Hospital Anxiety and Depression Scale 
(HAD)114 is a 14-item measure of depression and anxiety. 
• Parental post-traumatic stress: The Impact of Event Scale-Revised (IES-R)115 is a 
22-item measure of post-traumatic stress disorder. 
• Parental trust in medical team: The Trust in Physician Scale116 is a 10-item measure 
of trust in physicians. 
• Parental satisfaction with decision-making: The Pediatric Family Satisfaction with 
Care in the Intensive Care Unit (PFS-ICU 24)117 is a 24-item tool and will measure 
(1) satisfaction with care and (2) satisfaction with medical decision-making, 
modified for parents/caregivers of critically ill children. The Communication 
Assessment Tool-Team (CAT-T)118 is a 15-item tool that will measure patient 
perception of communication with the medical team and is adapted to team 
environments. A more complete outline of the survey is described below in the 
Appendix 11.14. 
• Parental feelings about communication with the clinical team: myICU119 is an 11 
item tool adapted by the authors of the tool to assess a surrogate’s perceptions of 
how comfortable the surrogate feels discussing potential concerns they have with 
their child’s medical team regarding their child’s care in the ICU.  
• Parental involvement in other family meetings  
• Fidelity of Parent Preparation and Acceptability: Parents will be surveyed on 
whether they were given the Family Preparation Worksheet and whether clinicians 
followed up on how they used the worksheet. They will be asked what they thought 
of the worksheet. They will also be asked about their acceptability of the Family 
Meeting Summary Worksheet. The use and acceptability survey was adapted from a 
Shared Decision Making tool. 120 See Appendix 11.15 for specific items. 
• Medical record review: Patient data will be retrieved from Epic and PC4 national 
database registry.  Data listed below are main patient record variables. See Appendix 
11.18 for full list of PC4 variables 
• Child’s name 
• Child’s MRN# 

 
  
 
 
 
22
• Child’s date of birth 
• Child race/ethnicity 
• Parent/legal guardian race 
• Parent/legal guardian contact number 
• Parent/legal guardian e-mail address 
• Parent/legal guardian address 
• Length of stay in the CICU 
• Length of stay in the hospital 
• EPIC Problem List 
• Medication list and administration dates throughout hospitalization 
• Limitations of interventions during study period 
• Date of limitations of interventions during study period 
• ICD-9 codes associated with hospitalization 
• Date of discharge from CICU / Date of death/ discharge from hospital 
• Discharge disposition from CICU and hospital (floor / home / rehab 
facility / palliative care / hospice) 
• Palliative care consult 
• Ethics consult 
• Gestational age 
• Fundamental Cardiac Diagnosis 
• Chromosomal abnormalities 
• Syndromes 
• Cardiothoracic surgery and date 
• Primary insurance type 
• Discharge 30 day mortality status  
• Number of prior cardiothoracic operations 
• Reason for CICU encounter 
• Non-cardiothoracic surgery 
• Encounter cardiothoracic diagnosis 
• Encounter medical diagnosis 
• DNR/DNI on file 
• Withdrawal of life sustaining therapy 
• Bleeding requiring reoperation and date 
• Unplanned reoperation/reintervention and date 
• Sternum left open and date 
• Cardiac arrest and date 
• Stroke and date 
• Risk group as measured by the STAT mortality category 
• operative or post-operative complications  

 
  
 
 
 
23
• Specialty notes related to CICU family meeting 
• CICU Summary Worksheet 
 
Interviews for Parent-patient Dyads in the Pre-Intervention 
• The interviews will cover parents’ experiences in family meetings and perspectives 
on communication with the clinical team. (See interview guide under Appendix 
11.16) 
Interviews for Parent-patient Dyads in the Post-Intervention 
• The interviews will assess parents’ acceptability of the parent-facing elements of the 
intervention, including preparing for the meeting and their perception of the written 
summary after the family meeting. (See interview guide under Appendix 11.17). 
Quantitative Coding of Audio Recordings of Actual Family Meetings 
• Modified VitalTalk coding scheme named SCOPE29,121,122: The small number of new 
codes added will measure engagement by the attending physician of team members 
from other disciplines, and adherence to elements of best practices in family 
meetings (e.g., facilitating introductions of participants, setting an agenda, and 
summarizing what was discussed in the meeting). Coders will be trained in the 
coding scheme using a manual with detailed definitions of all the codes. 
• Medical Interaction Process System (MIPS)80: MIPS is a previously validated coding 
scheme with good psychometric properties that was developed for training clinicians 
in communication and related research80. It has been used extensively in 
communication analysis83,123. MIPS draws upon a patient-centered approach and 
codes individual utterances between providers and patients allowing for coding of 
both content and affective information. 
• Time each member speaks during meeting: Team function will be analyzed by 
comparing the change in the number of minutes clinicians from each discipline speak 
in pre and post-CST meetings using linear regression and controlling for the length 
of the meetings.  
• Performance Assessment for Communication and Teamwork (PACT-Novice)124,125: 
The PACT Tool Set was developed to assess performance on team work and 
communication and builds upon the framework of TeamSTEPPS, a widely used 
system designed to improve patient safety, communication, and teamwork skills 
among health care professionals. The PACT-Novice tool will allow us to quickly 
train study staff to evaluate teamwork and communication behaviors.  
• Bruce et al. Evaluation Tool126: This novel evaluation tool was recently developed to 
assess family meetings, including clinician skills, team function, meeting leadership, 
and other elements of successful family meetings.  
 
Clinician Schedule of Evaluations 

 
  
 
 
 
24
Diagnostics/Measures Co-
design 
Pre-CST 
Actual 
Meetings 
Post-CST 
Evaluation 
Post-
CST 
Actual 
Meetings 
Focus Group 
X 
 
 
 
Focus Group Survey 
X 
 
 
 
Course Evaluation 
including Maslach 
burnout score and 
COVID-19 questions, 
demographics. 
 
 
X 
 
1 Month Follow-Up 
Acceptability 
Interview 
 
 
X 
 
Demographics 
 
X 
 
X 
CSADC-N 
 
X 
 
X 
SCOPE 
 
X 
 
X 
MIPS 
 
X 
 
X 
PACT-Novice 
 
X 
 
X 
Bruce et al. Evaluation 
Tool 
 
X 
 
X 
Time each member 
speaks 
 
X 
 
X 
 
Qualitative Coding of actual family meetings 
• Using a grounded theory, audio recordings will also be coded by 2 coders for 
thematic content to better understand team functioning and collaboration 
• Video recordings will be used for speaker attribution in the coding phase. 
 
Qualitative Coding of parent-patient dyad interviews 
• Using a grounded theory, audio recordings will also be coded by 2 coders for 
thematic content to better understand parental experiences communicating with the 
medical team in the CICU. 

 
  
 
 
 
25
5.2 Efficacy Evaluations 
5.2.1 Diagnostic Tests, Scales, Measures, etc. 
To gather feedback on the proposed CST program, clinicians and parents who participated 
in the co-design will be asked in focus groups which aspects of the training would facilitate 
their participation in a family meeting and sense of collaboration, which opportunities might 
have been missed, and whether the training addresses the core competencies in 
collaboration. Based on participant experience and feedback in the co-design sessions, the 
training will be modified to ensure its goals are met. A more complete outline of the co-
design group is described below in the Appendix 11.5. 
Clinicians who participate in the intervention will be given a course evaluation to determine 
their perception of the usefulness and satisfaction with CST. They will be asked to rate their 
level of agreement with aspects of the course on a 5 point Likert-type scale, have their level 
of burnout assessed using the Maslach burnout score,103 complete questions regarding 
changes that they have implemented regarding family meetings due to the 2020 COVID-19 
pandemic, and provide basic demographics. A random sample of 8 clinicians will also 
complete a 15-30 acceptability interview 1 month after the completion of the CST training. 
To evaluate team member perception and satisfaction with collaboration in actual family 
meetings, a validated tool will be used. The Baggs CSACD-N tool94,109 will measure team 
member perception and satisfaction with collaboration both pre and post-CST. 
To evaluate clinician behavior in actual meetings we will revise a content-based coding 
scheme for observable behaviors that reflect skills learned in the training. We will start with 
a coding scheme previously used in the VitalTalk studies given the significant overlap in 
learning goals29,121,122. The small number of new codes added will measure engagement by 
the attending physician of team members from other disciplines, and adherence to elements 
of best practices in family meetings (e.g., facilitating introductions of participants, setting an 
agenda, and summarizing what was discussed in the meeting). Coders will be trained in the 
coding scheme using a manual with detailed definitions of all the codes. All coders will code 
2 or 3 co-design encounters together to obtain a consensus. Coders will also be trained in the 
Medical Interaction Process System (MIPS) coding scheme. MIPS draws upon a patient-
centered approach and codes individual utterances between providers and patients, allowing 
for coding of both content and affective information80. Because multiple clinicians will 
participate in any meeting, acknowledgement of a skill will be attributed both collectively to 
the clinician team and to the individual from a specific discipline. For example, it may be 
the case that before CST only the social worker verbally expresses empathy, but post-CST 
attending physicians and bedside nurses also verbally express empathy in a meeting. This 
would be considered a change in clinician behavior if either more verbal expressions of 
empathy are made overall or if more clinicians from different disciplines make the same 
total number of verbal expressions of empathy. To evaluate if there are differences in 
clinician behavior pre and post-CST, coders will be blinded to whether an audio file was 
made prior to or after CST, and whether it was in a simulated or actual clinical encounter by 
playing files in a random order. 

 
  
 
 
 
26
To evaluate team function, the time each member speaks during the simulated or actual 
family meeting will be measured. We will compare the change in the number of minutes that 
clinicians from each discipline speak in pre and post-CST meetings using linear regression 
and controlling for the length of the meetings. We will slightly modify a team function tool, 
the PACT-Novice to measure team function in the team meetings125. In addition, we will use 
an evaluation tool which was recently developed by Bruce et al. that can be used to assess 
family meetings and clinician skills used during meetings to assess individual and team 
function126.  
To evaluate the fidelity of the intervention implementation in the post-intervention phase, a 
Fidelity Checklist used for each recorded meeting will be used.  
Taken together, the aforementioned measures will be used to assess the efficacy of the study 
intervention, including the development of the CST program, its perceived usefulness and 
satisfaction, its impact on communication skills and team function in simulated family 
meetings, and its impact on communication skills and team function in actual family 
meetings. 

 
  
 
 
 
27
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The focus group will yield qualitative data on how to improve the CST program. 
6.2 Secondary Endpoints 
The following secondary endpoints will be used to assess CICU providers’ perception of 
usefulness and satisfaction: 
• Standard descriptive statistics and differences in means and medians will be 
determined for perception of usefulness and satisfaction with CST. 
The following secondary endpoints will be used to assess CST impact on clinician behavior 
in simulated and actual family meetings: 
• Feasibility of the study will be evaluated by tracking trial enrollment and retention 
rates, consent rates, rates of missing data on parent and team reported outcomes, 
duration of family and team meetings.  
• Acceptability of the study will be evaluated with an acceptability interview and an 
acceptability satisfaction survey.120  
• SPIKES skills acquisition as assessed by the SCOPE tool. SPIKES is an acronym 
that stands for setting, perception, invitation, knowledge, emotion, and summary. It 
is a stepwise approach for giving bad news by preparing the setting; assessing the 
patient's perception; making an invitation to disclose the news; sharing the 
knowledge about the news; responding to the patient's emotion; and summarizing the 
plan29. 
• NURSE skills acquisition as assessed by SCOPE tool. NURSE is an acronym that 
stands for naming, understanding, respect, support, and exploring. It measures 
clinicians’ use of verbal empathetic expressions by how they name emotions; express 
understanding; show respect or praise for a patient’s behavior; articulate support for 
the patient; and explore the patient’s emotional state29. 
• Change in Medical Interaction Process System (MIPS) profile. MIPS is a previously 
validated coding scheme with good psychometric properties that was developed for 
training clinicians in communication and related research80. It has been used 
extensively in communication analysis83,123. MIPS draws upon a patient-centered 
approach and codes individual utterances between providers and patients, allowing 
for coding of both content and affective information80. 
• Team Function. Team function will be analyzed by comparing the change in the 
number of minutes clinicians from each discipline speak in pre and post-CST 
meetings using linear regression and controlling for the length of the meetings. 
• Team function will also be measured by changes in PACT-Novice scores and with 
the family meeting evaluation tool developed by Bruce et al.126 
• Change in kind of input offered by members of clinical team. 
The following secondary endpoints will be used to assess clinician burnout and changes in 
communication in family meetings during COVID-19 pandemic 

 
  
 
 
 
28
• The Maslach burnout scale, which uses Likert-type scales to measure aspects of 
burnout syndrome, including emotional exhaustion, depersonalization, and decreases 
in feelings of accomplishment.103,127  
• COVID-19 impact on communication in family meetings is a novel tool with 18 
questions measuring the modality of communication with families and colleagues 
prior to during COVID-19 pandemic.   
The following secondary endpoints will be used to assess CST impact on clinician behavior 
only in actual family meetings: 
• Modified Baggs CSACD-N tool94,128: The Baggs CSACD-N tool will measure team 
member perception and satisfaction with collaboration both pre and post-CST and 
will be given to all participating clinician team members. This tool will capture each 
discipline’s experience with collaboration with other team members and satisfaction 
with care decisions. The difference in team member perception of collaboration will 
be measured using the CSACD-N pre and post-CST training. Means and standard 
deviations will be calculated for the tool and t-tests will determine if there are 
significant differences for each discipline pre and post-CST. 
• Qualitative thematic analysis of family meetings that will identify if there are 
differences in themes prior to and after CST 
The fidelity of the intervention implementation will be assessed by a Fidelity Checklist.   
• The fidelity checklist will be scored by a study team member while reviewing the 
family meeting recording and reviewing information in Epic and parental survey 
responses.  A summary score will be calculated for each family meeting 
conducted and descriptive statistics will be calculated for the post-intervention 
family meetings. 
The following secondary endpoints will be used to assess parents’ perspectives about 
communication challenges in the CICU when talking with the clinical team: 
• In-person interviews prior to the intervention: These interviews will assess parents’ 
experiences in communicating in the CICU with the clinical team. A constructivist 
grounded theory approach will guide qualitative analysis of interview transcripts.  
• Control Preferences Scale for Pediatrics (CPS-P)113: The CPS-P will measure parent 
preferences for participation in treatment decision making pre-intervention and will 
be included in the survey given to 37 participating parent-patient dyads. Descriptive 
statistics will be calculated for quantitative data from this survey.  
• Hospital Anxiety and Depression Scale (HAD)114: The HAD Scale will measure 
parental levels of depression and anxiety pre-intervention and will be included in the 
survey given to 37 participating parent-patient dyads. Descriptive statistics will be 
calculated for quantitative data from this survey.  
• Impact of Event Scale-Revised (IES-R)115: The IES-R will measure parental levels of 
post-traumatic stress disorder pre-intervention and will be included in the survey 
given to 37 participating parent-patient dyads. Descriptive statistics will be 
calculated for quantitative data from this survey. 

 
  
 
 
 
29
• Trust in Physician Scale116: The Trust in Physician Scale will measure parental 
levels of trust in the clinical team pre-intervention and will be included in the survey 
given to 37 participating parent-patient dyad. Descriptive statistics will be calculated 
for quantitative data from this survey. 
• Pediatric Family Satisfaction with Care in the Intensive Care Unit (PFS-ICU 24)117: 
The PFS-ICU will measure parental satisfaction with care and medical decision-
making (modified for parents/caregivers of critically ill children) pre-intervention 
and will be included in the survey given to 37 participating parent-patient dyads. 
Descriptive statistics will be calculated for quantitative data from this survey. 
• Communication Assessment Tool-Team (CAT-T)118: The CAT-T, adapted to team 
environments, will measure parental perception of communication with the medical 
team pre-intervention and will be included in the survey given to 37 participating 
parent-patient dyads. Descriptive statistics will be calculated for quantitative data 
from this survey. This study will generate data that: a) is of substantial descriptive 
interest; b) will enable the evaluation of this population of CICU clinicians; c) will 
enable us to test the study’s hypotheses; and d) will enable us to estimate the size and 
precision of the associations between the variables specified in the hypotheses. 
• MyICU: The MyICU survey119, is an 11 item tool adapted by the authors of the tool 
to assess a surrogate’s perceptions of how comfortable the surrogate feels discussing 
potential concerns they have with their child’s medical team regarding their child’s 
care in the ICU.  Descriptive statistics will be calculated for quantitative data from 
this survey 
The following secondary endpoints will be used to assess parents’ acceptability with the 
family-facing intervention elements:  
• Fidelity of Parent Preparation and Acceptability: Parents will be surveyed on their 
use of and acceptability of Family Meeting Preparation Worksheet,120 and their 
acceptability of the Family Meeting Summary Worksheet. Items will be calculated 
with descriptive statistics and presented with means/medians.   
• Acceptability interviews with parents: These interviews will assess parental 
acceptance of the parent-facing elements of the intervention and will be coded by 2 
study team members using a grounded theory approach.   
The following secondary endpoints will be used to assess co-design participant engagement 
in the co-design process: 
• A survey comprising a 14-item section measuring participants’ perceptions of the 
Co-design leader’s effectiveness, a 10-item section measuring participants’ 
perceptions of their own involvement and commitment to the Co-design process, and 
demographic information. 
6.3 Statistical Methods 
6.3.1 Baseline Data  
Clinicians Participating in Actual Family Meetings and Intervention 

 
  
 
 
 
30
Burnout scales, COVID-19 communication, and  demographic characteristics will be 
summarized by standard descriptive summaries (e.g., means and standard deviations for 
continuous variables such as age and percentages for categorical variables such as gender). 
Parent-patient Dyad Survey Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g., means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). Descriptive statistics will be 
calculated for quantitative data from the survey. 
Parent-patient Dyad Interview Data 
Transcriptions of audio recorded interviews will be coded using Nvivo 11 by 2 coders. A 
consensus method will be used for discrepancies. A constructivist grounded theory approach 
will guide qualitative analysis of interview transcripts.  
Qualitative Data from Focus Groups 
Two coders will develop themes using a grounded theory approach and will code the 
transcripts of the focus groups. NVIVO software will be used to apply codes to the 
transcripts by 2 independent coders. Discrepancies will be resolved by consensus. 
Focus Group Survey Data 
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g., means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). Descriptive statistics will be 
calculated for quantitative data from the survey. 
6.3.2 Efficacy Analysis 
Qualitative analysis of focus groups conducted during the co-design session will identify 
themes for elements of the training that may need to be modified. 
To evaluate the reliability and validity of the coding scheme, audio recordings from 
simulated family meetings will be coded and compared to coded audio recordings from pre-
intervention simulated family meetings. Inter-rater reliability will be confirmed by having a 
random sample of 10% of the audio files coded twice by different coders. Only codes with K 
statistic greater than 0.6 will be included in the final analysis. Convergent validity of the 
revised coding scheme will be assessed by computing the correlations between the revised 
VitalTalk coding scheme and the comparable content categories of the MIPS. For this, audio 
files will be coded using both coding systems and spearman rank correlations will be 
calculated between the two systems. Coefficients greater than 0.50 will indicate a good level 
of concurrence between the behaviors measured by the two interaction systems. To evaluate 
if there are differences in clinician behavior pre and post-CST, coders will be blinded to 
whether an audio file was made prior to or after CST, and whether it was in a simulated or 
actual clinical encounter by playing files in a random order.  

 
  
 
 
 
31
To evaluate differences in individual skills acquired (SPIKES, NURSE, interprofessional 
competencies) in simulated family meetings, we will use the McNemar test to compare the 
proportion of subjects possessing a skill pre-CST in simulated encounters with the 
proportion who possessed the skill after CST. Each skill will be analyzed separately. The 
comparison will be made for each behavior assessed and each clinician discipline that 
demonstrates the behavior. We will also estimate the probability that a participant who did 
not demonstrate a skill in the pre-CST would demonstrate that skill in the post-CST as a 
simple ratio. We will estimate 95% confidence intervals using standard techniques. We will 
also use paired t-tests to examine if there is a difference in skill acquisition (using the 
continuous version of each of the skill outcomes) between the pre- and post-CST 
intervention and Wilcoxin signed rank tests. 
Team function will be analyzed for simulated family meetings by comparing the change in 
the number of minutes that clinicians from each discipline speak in pre and post-CST 
meetings using linear regression and controlling for the length of the meetings. 
To assess the impact of the CST program in actual family meetings, audio recordings from 
actual family meetings will be coded and compared to coded audio recordings form pre-
intervention actual family meetings. Since there are generally at least 2 clinicians in each 
team encounter, we will examine the individual skill acquisition within each part of the team 
encounter. Within each discipline, there are several clinicians involved in multiple team 
meetings. We will use fixed-effects regression with a clinician identifier variable as a 
covariate so that we can examine the effect of CST intervention on skill acquisition, 
adjusting for the effects of individual clinicians. 
Team function will be analyzed in the same way as in simulated meetings by comparing the 
change in the number of minutes that clinicians from each discipline speak in pre and post-
CST meetings using linear regression and controlling for the length of the meetings. 
The difference in team member perception and satisfaction with collaboration will be 
measured after their participation in clinical encounters both pre and post-CST by 
administering the modified Baggs CSACD-N tool to all clinician team members who 
participate in an actual encounter. This tool will capture each discipline’s experience with 
collaboration with other team members and satisfaction with care decisions. Means and 
standard deviations will be calculated for the tool and t-tests will determine if there are 
significant differences for each discipline pre and post-CST. 
Hypotheses will be tested using logistic regression modeling with significance of the two-
tailed hypothesis tests set at alpha equal to 0.05. 
Clinician perception of the usefulness of CST and satisfaction with the training will be 
identified by descriptive statistics and differences in the mean and median scores will be 
calculated to determine retention in perceptions of usefulness one month after the training.   
6.4 Sample Size and Power 
We hypothesize that the CST will change clinician behavior by increasing the number of 
skills demonstrated in a simulated family meeting. Sample size calculations using existing 
data about acquisition of skills being evaluated in the CST29 demonstrated that a total of 20 

 
  
 
 
 
32
clinicians will be needed to identify significant changes in the following skill outcomes: 
discussing the big picture, responding to emotion, and performing several empathetic verbal 
skills using 80% power and an alpha=0.05. 
Sample size calculations for determining change in clinician skill acquisition by discipline 
requires that there be an adequate number of actual encounters recorded such that they can 
be analyzed by provider type. Sample size calculations for simulated family meetings apply 
here as well in that we will need to have at least 20 team encounters pre and post-CST 
intervention to be able to look at the change in outcome before and after the intervention. 
Since there are generally at least 2 clinicians in each team encounter, we will examine the 
individual skill acquisition within each part of the team encounter. Within each discipline, 
there are several clinicians involved in multiple team meetings. We will use fixed-effects 
regression with a clinician identifier variable as a covariate so that we can examine the effect 
of CST intervention on skill acquisition, adjusting for the effects of individual clinicians.  
Team function will be analyzed by comparing the change in the number of minutes that 
clinicians from each discipline speak in pre and post-CST meetings using linear regression 
and controlling for the length of the meetings. Sample size calculations based on previous 
data87 and assuming 80% power and an alpha=0.05 will only require 3 paired respondents 
pre and post-CST to identify significant differences.  
A sample size of 130 parent-patient dyads for the survey and 30 parent-patient dyads for the 
interview is based on using CONSORT recommendations for pilot study sample size 
calcuations. We calculated the parent-patient dyad sample size by estimating the required 
sample size for the future stepped wedge study using the Hospital Anxiety and Depression 
Scale (HADS) as the primary outcome for parents, as HADS is a frequently used outcome in 
palliative care research with well-established psychometric properties.129,130  We will assume 
a one sided 80% CI for the effect size of 0.1 times the SD, to exclude the minimum 
clinically important difference if the null hypothesis is true.131  The minimally important 
difference is a change of 2 on the HADS scale. The estimated sample size for the main study 
would be 286.  For the pilot study, we estimated the number of participants required as 
around 30% of the number required for the main Phase 3 trial therefore, we aim to enroll a 
total of 46 parent-patient dyads pre and post the intervention. In previous studies enrolling 
parents and children with serious illness, our approach-to-enrollment rate was above 50%. 
Assuming 45% or more of parent-patient dyads approached will enroll and there are 150 
eligible patients per year, we will need to approach approximately 350 parent-patient dyads 
to enroll 130 evaluable parent-patient dyads for the survey and 30 evaluable parent-patient 
dyads for the interview prior to the intervention. We have allotted 24 months to enroll 46 
evaluable parent-patient dyads for the survey and 20 evaluable parent-patient dyads for the 
interview pre-intervention.  
6.5 Interim Analysis 
None planned. 
 
 
 

 
  
 
 
 
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7 
SAFETY MANAGEMENT 
7.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  

 
  
 
 
 
34
8 
STUDY ADMINISTRATION 
8.1 Treatment Assignment Methods 
8.1.1 Blinding 
No blinding will be used in the study given the differences in acquiring data prior to and 
after the COVID pandemic.   
8.2 Data Collection and Management 
All data will be stored on CHOP approved and maintained computers with compliant 
firewalls and security settings. All data will be saved onto CHOP password protected servers 
that are maintained by IS. All computers accessing data will be password-protected, and 
encrypted data files will be used when necessary to share data between users. Any paper 
files produced will be maintained in a locked file cabinet in locked offices. Data will be 
shared using CHOP secured shared drives or encrypted flash drives, or encrypted emails. If 
flash drives or other removable media are used, they will conform to meet CHOP IT 
standards for encryption and password protection according to CHOP policy A-3-6 
(http://intranet.chop.edu/patcare/a-3-6.pdf ). The information will not be released to those 
outside the study team.  
Subjects Participating in Co-Design 
Focus group data will be digitally recorded, transcribed, and de-identified. De-identified 
transcripts will be imported into NVIVO, a qualitative data analysis program. 
Clinicians Participating in Intervention 
Survey responses from clinicians will be entered into the web-based questionnaire in 
REDCap. At the time of administration, the instruments will be coded with a number that is 
linked to the participant, so that once the study is complete, none of the research information 
can be linked back to any particular participant. Only research team members will have 
access to the raw data, to the statistical database, and to the database that links study ID 
numbers with participants’ personal information.  
Audio or video recordings of intervention sessions will be stored on CHOP approved and 
maintained computers with compliant firewalls and security settings. Online intervention 
sessions will use a video conference service that meets the relevant CHOP IT standards and 
is HIPPAA compliant.  All data will be saved onto CHOP password protected servers that 
are maintained by IS. 
Data collected as part of this study will be entered and stored into REDCap. REDCap is a 
research-focused electronic data capture system, under an agreement with the software’s 
development consortium, led by Vanderbilt University. REDCap supports two secure, web-
based applications designed exclusively to support data capture for research studies. 
REDCap is a PHP web application served by Apache Tomcat over a 128 bit SSL connection 
using a signed certificate. The application relies on a study-specific data dictionary defined 
in an iterative self-documenting process that will be conducted by all members of the 
research team. The data dictionary is the foundation for custom case report form design and 

 
  
 
 
 
35
validated coding of variables. Authentication of research staff will be performed via LDAP 
using CHOP’s enterprise Active Directory service. The application generates a complete 
audit trail of user activity, provides reporting, and has an automated export mechanism to 
common statistical packages (SAS, SPSS, Stata, R/S-Plus). 
The REDCap MySQL database is replicated in real time to a completely redundant instance 
of MySQL. The redundant instance is available for restoration of the primary database or for 
manual failover in the case of primary database failure. Time-stamped backup files are made 
from the replicated database daily by CHOP Research Information Systems using automated 
backup routines. Backup files are encrypted and transferred to a secure file server accessible 
only to designated personnel. A rolling seven day window of backup files is maintained in 
an immediately available online state, with a larger window maintained in a compressed file 
archive available at a reduced speed of access. Daily destructive database backup files are 
stored on the database server and are deleted only after successful backup of the entire 
database to file. In the event of data error, loss or corruption, research personnel will work 
with CHOP Research Information Systems to determine the most appropriate recovery 
strategy.  
Data and backups are stored in the CHOP Research Information Systems Storage Area 
Network (SAN). Access to the SAN directories where data are stored will be limited to 
Research Information Systems personnel, with authentication performed using CHOP’s 
enterprise Active Directory service.  
Audio or video recordings of family meeting sessions will be stored on CHOP approved and 
maintained computers with compliant firewalls and security settings. Online family 
meetings sessions will use a video conference service that meets the relevant CHOP IT 
standards and is HIPPAA compliant.  All data will be saved onto CHOP password protected 
servers that are maintained by IS.  Audio transcripts of the family meeting will be made, and 
de-identified and then will be imported into NVIVO, a qualitative data analysis program.  
Video recordings will only be used for speaker attribution.   
Parent-patient Dyads Participating in the Survey or Interview 
Both survey responses and responses from the Family Meeting Preparation Worksheet from 
parent-patient dyads will be entered into the web-based questionnaire in REDCap. At the 
time of administration, the instruments will be coded with a number that is linked to the 
participant, so that once the study is complete, none of the research information can be 
linked back to any particular participant. Only research team members will have access to 
the raw data, to the statistical database, and to the database that links study ID numbers with 
participants’ personal information.  
Data collected as part of this study will be entered and stored into REDCap.  
Interview data will be digitally recorded or recorded with an online video conference service 
that meets the relevant CHOP IT standards and is HIPPAA compliant and will be 
transcribed, de-identified and imported into NVIVO, a data analysis program. 
Medical record review will be done by DBHI and PC4 groups and shared with the research 
team using secured shared drives and electronic files via secured email.   

 
  
 
 
 
36
 
8.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
institutional policies and HIPAA on subject privacy. The Investigator and other research 
team members will not use such data and records for any purpose other than conducting the 
study. During the consent process and before administering the surveys, clinicians and 
parent-patient dyads will be told that their responses will be kept confidential. Clinicians and 
parents participating in the co-design focus groups and parent-patient dyads participating in 
the interviews will be told that all identifying information will be removed from transcripts. 
Once transcribed, the original co-design focus group audio files will be destroyed, reducing 
risk to breach of confidentiality.   Original interview audio and video files will be destroyed 
once the study is completed and analyses are submitted and accepted into peer-reviewed 
journals. Clinicians completing surveys after actual family meetings will also be assured that 
their responses to the surveys will be kept confidential from other members of the medical 
team and from patients and families that they care for. In addition, parent-patient dyads will 
also be told that medical information audio and video recorded during the observed family 
meetings or acquired from the Family Meeting Worksheet in RedCap will be kept 
confidential. PHI for all patients will be deleted after completion of the study by deleting the 
audio and video files that contain that information. 
After publication of data and analyses, identifiable information will be removed from the 
database and data collection materials.  
Data used for future studies will not contain any identifiable information. The investigator 
will obtain a data use agreement between the PI and any recipient researchers before sharing 
a dataset that is not readily identifiable. 
A Certificate of Confidentiality (CoC) issued by the NIH now covers this research. A CoC 
helps protect participant identifiable information. 
A CoC protects private information from all legal proceedings. Unless participant consents, 
information from this research study that identifies them will not be shared outside this 
research.  
• No one can be forced to share participant identifiable information for a 
lawsuit. 
• information can't be used as evidence even if there is a court subpoena.  
If participant consents,  information could be shared for:  
• Other future scientific research; 
The CoC does not prevent some disclosures.  
• The researchers can't refuse requests for information from those funding this 
research. The National Heart, Lung, And Blood Institute of the National 
Institutes of Health may need information to assess this project.  

 
  
 
 
 
37
• The researchers must disclose things required by law. This includes suspected 
child abuse and neglect, harm to self or others, or communicable diseases. 
 
8.4 Regulatory and Ethical Considerations 
8.4.1 Data and Safety Monitoring Plan 
The master list encoding study code identifiers to personal identifiers will be encrypted and 
access will be restricted to the PI and members of the research team. All study data, 
including the master list and PHI, will be retained for at least 6 years following study 
completion. All completed study documents will be stored in locked cabinets, and all 
computer-entered data will be stored and analyzed on password-protected computers at The 
Children’s Hospital of Philadelphia. Access to documents and data will be limited to the PI 
and members of the research team. The PI will be responsible for ensuring that all those with 
access to the information understand the requirements for use of the data on password 
protected computers and servers. Any transfer of data between members of the research 
team will be done through encrypted emails, flash drives, or external hard drives that meet 
CHOP IT standards. The PI will monitor data progress and/or subject safety. 
8.4.2 Risk Assessment 
Subjects Participating in Co-design: The study risks include a breach of confidentiality of 
responses in focus groups and survey responses. This presents no more than minimal risk of 
everyday life. Participation in the study will not be required for employment and others 
outside the research team will not be notified of an individual provider’s participation in this 
study, including the CST co-design program. Audio recordings and transcripts from focus 
groups will remain confidential and will have identifying information removed at the time of 
transcription. Original audio files will be destroyed once transcription has been completed. 
All data will be collected and maintained securely as outlined in the data monitoring section. 
Information will be stored on password protected computers and servers. No information 
will be shared outside the research team and all identifying information in original audio 
files will be destroyed once the audio files have been transcribed and checked for accuracy, 
no earlier than 6 years after study completion. 
Clinicians Participating in Intervention: The study risks include a breach of 
confidentiality of survey answers, audio and video recordings from family meetings, and/or 
audio and video recordings of didactic CST sessions. This presents no more than minimal 
risk of everyday life. Participation in the study will not be required for employment and 
others outside the research team will not be notified of an individual provider’s participation 
in this study, including the CST program. Results of all surveys and audio coding will 
remain confidential. If subjects indicate that they would like additional emotional or 
professional support after completion of survey questions assessing confidence in 
performance of skills, referral to the employee assistance program will be suggested by the 
research team. There are multiple research studies and QI projects conducted in the CICU 
which assess clinician competency, therefore clinicians are accustomed to being interrogated 
about their comfort level and clinical skills and even having those skills tested as part of 
research. All data will be collected and maintained securely as outlined in the data 

 
  
 
 
 
38
monitoring section. Information will be held on password protected computers and servers. 
No information will be shared outside the research team, and all identifying information will 
be destroyed once the study is completed and analyses are submitted and accepted into peer-
reviewed journals, no earlier than 6 years after study completion. 
Clinicians Not Participating in Intervention: The study risks include a breach of 
confidentiality of the audio and video recordings from family meetings. This presents no 
more than minimal risk of everyday life. These clinicians were already planning to 
participate in the family meetings. Participation in the study will not be required for 
employment and others outside the research team will not be notified of an individual 
provider’s participation in this study, including the CST program. Results of all surveys, and 
audio coding will remain confidential. All data will be collected and maintained securely as 
outlined in the data monitoring section. Information will be held on password protected 
computers and servers. No information will be shared outside the research team, and all 
identifiable information will be destroyed once the study is completed and analyses are 
submitted and accepted into peer-reviewed journals, no earlier than 6 years after study 
completion. 
Parent-patient Dyads Participating in the Survey or Interview: The study risks include a 
breach of confidentiality of the parent-patient dyad’s survey and/or audio or video 
recordings from interviews. This presents no more than minimal risk of everyday life to 
participants. Participants should not require medical or psychological care for their 
participation in the survey. If they need to end participation at any time, this will not affect 
their child's care in any way, and they will be allowed to end participation. Results of all 
surveys, interviews, and audio coding will remain confidential. All data will be collected 
and maintained securely as outlined in the data monitoring section. Information will be held 
on password protected computers and servers. No information will be shared outside the 
research team and all identifiable information will be destroyed once the study is completed 
and analyses submitted and accepted into peer-reviewed journals, no earlier than 6 years 
after study completion. 
8.4.3 Potential Benefits of Trial Participation 
Subjects Participating in Co-design 
Participating clinician and parent subjects may benefit directly from participation in the 
study because they will learn about communication skills training based on adult learning 
theory, best practices in communication theory, and best practices in team functioning. We 
hypothesize that exposure to this training will enhance their ability to interact with their 
colleagues, their patients, and their patients’ families, ultimately positively impacting health 
outcomes. 
The knowledge gained from this research will provide important information for improving 
communication skills and team function for clinical teams in the CICU. 
Clinicians Participating in Intervention 
Participating clinician subjects may benefit directly from participation in the study because 
they will undergo additional communication skills training based on adult learning theory, 

 
  
 
 
 
39
best practices in communication theory, and best practices in team functioning. We 
hypothesize this training will enhance their ability to interact with their colleagues, their 
patients, and their patients’ families, ultimately positively impacting health outcomes.  
The knowledge gained from this research will provide important information for improving 
communication skills and team function for clinical teams in the CICU. 
Clinicians Not Participating in Intervention 
Non-participating clinicians will not benefit directly from participation in the study. 
However, the knowledge gained from this research will provide important information for 
improving communication skills and team function for clinical teams in the CICU. 
Parent-patient Dyads Participating in the Survey or Interview 
There will be no direct benefit to parents or patients for taking part in this study. However, 
the knowledge gained from this study may help doctors improve their teamwork and 
communication skills. Knowledge gained from this study may also help teams and families 
better prepare families for family meetings. 
8.4.4 Risk-Benefit Assessment 
Data collected from this study could contribute to further strides in the field of health 
communications, where both patients and providers will benefit from more awareness of 
their communication needs, and more empowerment to engage in effective communication. 
This strengthened patient-provider communication has implications across many disciplines 
within medicine but particularly in the CICU, where medical decision-making is very 
complex and stressful for families. As a minimal risk study, the risk to subjects is reasonable 
given the potential benefit to subjects, future studies, and society at large. The knowledge 
gained from this research will provide important information for improving interprofessional 
teams’ engagement with families when giving them bad news and eliciting goals of care in 
the pediatric CICU. This CST may also improve team functioning and collaboration in 
patient care. 
8.5 Recruitment Strategy 
Subjects Participating in Co-Design: Members of clinical teams will be recruited into the 
study through an open announcement of the study by the study team at faculty meetings and 
via a faculty and staff listserv that will give them contact information to follow up with a 
study team member if they are interested in participating (See Appendix 11.1 for recruitment 
email). Parents will be offered the opportunity to participate in an open call via the Parent 
Family Advisory Council listserve and emails to families that meet enrollment critieria.  
Approximately 15 clinicians and 5 parents will be enrolled for the co-design.  
Clinicians Participating in Intervention: CICU clinicians will be recruited into the study 
through an open announcement of the study by the study team at faculty meetings and via a 
faculty and staff listserv that will give them contact information to follow up with a study 
team member if they are interested in participating (See Appendix 11.2 for recruitment 
email). At least 20 clinicians will be consented and enrolled for the intervention, survey and 

 
  
 
 
 
40
interview.  Block randomization will be done based on study ID number to select which 
clinicians will be asked to participate in an acceptability interview.  
Clinicians Not Participating in Intervention: Working with several CICU team members, 
we will identify family meetings that are scheduled and will include at least 2 clinicians who 
are participating in the intervention. We will confirm with the primary team who the other 
clinicians are that are likely to be present in the meeting and we will contact them either via 
email or in person to discuss enrollment into the study.   
Parent-patient Dyads Participating in the Survey or Interview Prior to Intervention: 
We will identify via medical record screening patients who have been admitted to the CICU 
for at least 7 days and are expected to stay for at least another 7 days and whose parents are 
therefore eligible for participation in a complex care family meeting. Parent-patient dyads 
will be approached in person  by a member of the research team to consent to participate in 
the study or will be called to determine when they will next be present in the CICU for 
further discussion of the study. Up to 100 parent-patient dyads for the survey and 30 parent-
patient dyads for the interview will be consented and enrolled with the expectation that we 
will achieve 95 evaluable parent-patient dyads for surveys and  23 evaluable parent-patient 
dyads for interviews. 
Parent-patient Dyads Participating in the Survey or Interview After Intervention: We 
will identify via medical record screening patients who have been admitted to the CICU for 
at least 7 days and are expected to stay for at least another 7 days,or the patient has already 
been admitted to the CICU 14 days and whose parents are therefore eligible for participation 
in a complex care family meeting. Parent-patient dyads will be approached in person, over 
the phone or via e-mail by a member of the research team to consent to participate in the 
study or will be called to determine when they will next be present in the CICU for further 
discussion of the study. Up to 50 parent-patient dyads will be enrolled for, with a goal of 30 
evaluable patient-parent dyads for the survey. Up to 25 parent-patient dyads (of the 50 
enrolled for the survey) will be invited to be interviewed in the post-intervention, with a goal 
of 15 evaluable parent-patient dyads. 
8.6 Informed Consent/Assent and HIPAA Authorization 
Subjects Participating in Co-design 
For participating subjects, a member of the study team will obtain written informed consent, 
or eConsent, and will explain the rationale, risks, and benefits of the study prior to any study 
related procedures being performed, including training and data collection. The clinicians 
will be given a thorough explanation of the study as provided in the consent document. 
These include the purpose, procedures, risks and benefits of participation, confidentiality, 
procedures for withdrawal, and contact information for study personnel. After receiving the 
written consent or eConsent from participating clinician subjects, they will be given a copy 
of the consent form for their records. In the event that eConsent is used, the document will 
be logically associated with each subject and will be able to be printed or saved to fulfill 
requirements related to electronic signatures. They will also be informed that their 
employment at CHOP will not be jeopardized if they choose not to participate in the 
proposed research. 

 
  
 
 
 
41
Clinicians Participating in Intervention 
For clinician subjects participating in the intervention, a member of the study team will 
obtain written informed consent, or eConsent, and will explain the rationale, risks, and 
benefits of the study prior to any study related procedures being performed, including 
training and data collection. The clinicians will be given a thorough explanation of the study 
as provided in the consent document. These include the purpose, procedures, risks and 
benefits of participation, confidentiality, procedures for withdrawal, and contact information 
for study personnel. After receiving written consent or eConsent from participating clinician 
subjects, they will be given a copy of the consent form for their records. In the event that 
eConsent is used, the document will be logically associated with each subject and will be 
able to be printed or saved to fulfill requirements related to electronic signatures.  We have 
worked with REDCap administrators to build eConsent and will utilize only IRB approved 
documents in the eConsent process with the help of REDCap administrators.  They will also 
be informed that their employment at CHOP will not be jeopardized if they choose not to 
participate in the proposed research. 
Clinicians Not Participating in Intervention 
For clinicians not participating in the intervention, a member of the study team will obtain 
written informed consent or consent via email and will explain the rationale, risks, and 
benefits of the study prior to any study related procedures being performed, including data 
collection. The clinicians will be given a thorough explanation of the study as provided in 
the consent document. These include the purpose, procedures, risks and benefits of 
participation, confidentiality, procedures for withdrawal, compensation, and contact 
information for study personnel. After receiving consent from the clinicians, we will give 
them a copy of the consent form for their records or they will receive a copy of the consent 
form via email. They will also be informed that their employment at CHOP will not be 
jeopardized if they choose not to participate in the proposed research. 
Parent-patient Dyads Participating in the Survey Prior to the Intervention  
For participating parent-patient dyads, a member of the study team will obtain written 
informed consent,consent via the phone and will explain the rationale, risks, and benefits of 
the study prior to any study related procedures being performed, including data collection. 
The parent-patient dyads will be given a thorough explanation of the study as provided in 
the consent document. These include the purpose, procedures, risks and benefits of 
participation, confidentiality, procedures for withdrawal, financial information, and contact 
information for study personnel. After receiving consent from participating parent-patient 
dyads, they will be given a copy of the consent form for their records. They will also be 
informed that their choice to participate or not will not impact how the clinical team cares 
for their family. 
This study requests a waiver of assent for child subjects. Given that child subjects will be 
recruited from the ICU, many of them may be sedated or too ill to comprehend the study 
purposes and procedures and assent to participation. However, the use of child subject 
medical records will be clearly outlined in the consent form provided to parents/legal 
guardians. 

 
  
 
 
 
42
Parent-patient Dyads Participating in the Interview Prior to the Intervention  
For participating parent-patient dyads, a member of the study team will obtain written 
informed consent or consent via the phone and will explain the rationale, risks, and benefits 
of the study prior to any study related procedures being performed, including data collection. 
The parent-patient dyads will be given a thorough explanation of the study as provided in 
the consent document. These include the purpose, procedures, risks and benefits of 
participation, confidentiality, procedures for withdrawal, financial information, and contact 
information for study personnel. After receiving consent from participating parent-patient 
dyads, they will be given a copy of the consent form for their records. They will also be 
informed that their choice to participate or not will not impact how the clinical team cares 
for their family. 
Parent-patient Dyads Participating in the Survey and Interview After the Intervention  
For participating parent-patient dyads, a member of the study team will obtain written 
informed consent, consent via the phone, or eConsent and will explain the rationale, risks, 
and benefits of the study prior to any study related procedures being performed, including 
data collection. The parent-patient dyads will be given a thorough explanation of the study 
as provided in the consent document. These include the purpose, procedures, risks and 
benefits of participation, confidentiality, procedures for withdrawal, financial information, 
and contact information for study personnel. After receiving consent from participating 
parent-patient dyads, they will be given a copy of the consent form for their records. In the 
event that eConsent is used, the document will be logically associated with each subject and 
will be able to be printed or saved to fulfill requirements related to electronic signatures.  
We have worked with REDCap administrators to build eConsent and will utilize only IRB 
approved documents in the eConsent process with the help of REDCap administrators. They 
will also be informed that their choice to participate or not will not impact how the clinical 
team cares for their family. 
This study requests a waiver of assent for child subjects. Given that child subjects will be 
recruited from the ICU, many of them may be sedated or too ill to comprehend the study 
purposes and procedures and assent to participation. However, the use of child subject 
medical records will be clearly outlined in the consent form provided to parents/legal 
guardians. 
 
8.6.1 Selecting Family Meetings 
Working with several CICU team members, we will identify family meetings that are 
scheduled. We will confirm with the primary team planning the family meeting which 
family members are likely to be present and we will contact them either via phone,in person 
or via e-mail to discuss the study. We will also confirm with the primary team who the other 
clinicians are that are likely to be present in the meeting and we will contact them either via 
email or in person to discuss the study. 
When audio or video recording participating clinicians during actual family meetings, others 
present at the meeting will be recorded as well. This will include parents, patients, and 

 
  
 
 
 
43
clinician team members participating in an observed family meeting who did not undergo 
the CST (because they were not eligible, did not wish to participate in the study, or were not 
approached because sufficient clinicians were already enrolled).  
Parent-Patient Dyads Prior to the Intervention  
During recruitment within the CICU in-patient units, a member of the research team will 
approach parents and patients who will be participating in an observed family meeting in the 
patient room, or over the phone  if the parents will not be in the CICU prior to the family 
meeting and provide information about the study. A member of the study team will present a 
one-page explanation of the study to the parents. The explanation will cover the purpose of 
the study, procedures, risks and benefits of participation, what information will be collected, 
contact information for study personnel, that their private information will not be written 
down or used, and that parents can opt-out at any time.  
Patients who are 18 years old and will be present in the audio recorded family meeting will 
be allowed to opt-out as adults if they are medically and cognitively capable of 
comprehending study purposes and can decline participation.  
Parent-Patient Dyads After the Intervention  
During recruitment within the CICU in-patient units, a member of the research team will 
approach parents and patients who will be participating in an observed family meeting in the 
patient room, or over the phone, or via email if the parents will not be in the CICU prior to 
the family meeting and provide information about the study. A member of the study team 
will consent the parents prior to study procedures would begin.  The explanation will cover 
the purpose of the study, procedures, risks and benefits of participation, what information 
will be collected, contact information for study personnel, that their private information will 
not be written down or used, and that parents can opt-out at any time.  
Patients who are 18 years old and will be present in the audio or video recorded family 
meeting will be allowed to opt-out as adults if they are medically and cognitively capable of 
comprehending study purposes and can decline participation.  
 
8.7 Payment to Subjects/Families 
Clinicians and parents participating in the co-design will be given $25 per hour session, 
totaling $275 for all 11 sessions in the form of a debit card or gift card. Clinicians 
participating in the intervention will be given $100 for the entirety of the intervention 
participation. Parent subjects will be given $10 in the form of a debit card or gift card upon 
completion of either the survey or the interview in the pre-intervention. Parent subjects will 
be given $20 in form of a debit card or gift card upon completion of the survey or the 
interview in the post-intervention. Patient subjects will not receive any payment for their 
participation. 

 
  
 
 
 
44
9 
PUBLICATION 
We aim to publish findings of this study in peer-reviewed articles in leading medical 
journals. We will also present findings at professional meetings. 
 
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1. 
Blume E, Morell Balkin E, Aiyagari R, et al. Parental Perspectives on Suffering and 
Quality of Life at End-of-Life in Children With Advanced Heart Disease: An Exploratory 
Study. Pediatric critical care medicine. 2014;15(4):336-342.  
2. 
Contro N, Larson J, Scofield S, Sourkes B, Cohen H. Family perspectives on the 
quality of pediatric palliative care. Arch Pediatr Adolesc Med. Jan 2002;156(1):14-19.  
3. 
Meert KL, Eggly S, Pollack M, et al. Parents' perspectives on physician-parent 
communication near the time of a child's death in the pediatric intensive care unit. Pediatr 
Crit Care Med. Jan 2008;9(1):2-7. doi:10.1097/01.PCC.0000298644.13882.88 
4. 
Studdert DM, Burns JP, Mello MM, Puopolo AL, Truog RD, Brennan TA. Nature of 
conflict in the care of pediatric intensive care patients with prolonged stay. Pediatrics. Sep 
2003;112(3 Pt 1):553-8.  
5. 
Meyer E, Ritholz M, Burns J, Truog R. Improving the quality of end-of-life care in 
the pediatric intensive care unit: Parents' priorities and recommendations. Pediatrics. 
2006;117:649-657.  
6. 
Needle JS, O'Riordan M, Smith PG. Parental anxiety and medical comprehension 
within 24 hrs of a child's admission to the pediatric intensive care unit. Pediatr Crit Care 
Med. Nov 2009;10(6):668-74; quiz 674. doi:10.1097/PCC.0b013e3181a706c9 
7. 
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