We Chatt (Communication, Hopes, Action, Tips and Team) A Study to Improve Physician-Youth Communication and Medical Decision Making
Phase: NA
Conditions: Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Sponsor: University of Michigan

WE CHATT: A Pilot Study to Improve Physician-Youth 
Communication and Medical Decision Making 
 
NCT05835063 
 
Date of IRB Approval: April 6, 2023 
 

Page 1 of 4 
 
WE CHATT: A PILOT STUDY TO IMRPOVE PHYSICIAN-YOUTH COMMUNICATION AND 
MEDICAL DECISION MAKING 
BACKGROUND 
Prevalence and Impact of Pediatric Heart Failure. Congenital heart disease (CHD), the most 
common birth defect, impact 1 in every 100 live births.36,37 Due to significant medical 
advancements, many children born with CHD now survive into adolescence and beyond. In 
1985, CHD patients were on average 11 years old. In 2000, the mean age had increased to 17 
years old.38 For the growing population of adolescents and young adults (AYAs; 12-24 years) 
with congenital and acquired heart diseases, survival comes at a cost. Common complications, 
including heart failure and arrhythmias, require intensive, long-term medical care which has a 
significant financial impact on society. An estimated 6 billion dollars are spent each year on 
CHD-related acute care costs,39 accounting for some of the highest resource utilization among 
all hospitalized children. Approximately 14,000 children experience heart-failure related 
hospitalizations annually in the US, and the average length of admission has increased over the 
past two decades. Among this group, 7% die during their hospitalization – a mortality rate nearly 
20 times greater than that among children without heart failure and approximately double that in 
adult heart failure.27 For those with advanced heart failure, ventricular assist device therapies 
and heart transplantation offer potential for extended survival. However, 1/10 heart transplant 
recipients will die within a year of transplant.28 For patients with implanted ventricular assist 
devices as a bridge to transplant or destination therapy (i.e., life-extending intervention for 
patients who do not meet criteria for transplantation), mortality and morbidity are significant with 
high rates of stroke, bleeding and sepsis.33 In PI’s study of medical decision making preferences 
among AYAs pre-heart transplant or post-transplant with serious complications, 6/16 eligible 
participants (38%) died before study enrollment/completion. Young people who die of heart 
failure overwhelmingly do so in intensive care settings.30 Rates of hospital-based deaths 
accompanied by costly and invasive interventions near the end of life are exceedingly higher in 
pediatric heart failure populations when compared to other illness groups with similar disease 
severity. For example, more than 50% of youth with progressive cancer die at home. Of those 
with cancer who died in hospital settings, 45% received mechanical ventilation within the last 24 
hours of life40 compared to 86% of youth who died of heart disease.30 
 
Palliative and End of Life Care in Heart Failure. The 2014 Institute of Medicine (IOM) report, 
Dying in America: Improving Quality and Honoring Individual Preferences Near End of Life,29 
highlighted a critical need for “increased understanding of ways to improve participation in 
effective advance care planning and shared decision making among patients and families, 
including seriously ill children and adolescents, who may be able to participate actively in their 
health care decision making throughout their lives and as they approach death, and receive 
medical and related social services consistent with their values, goals and informed 
preferences.” Research on the end of life and palliative care needs of the growing AYA heart 
failure population is very limited.30–32 Youth with heart failure are also less likely to receive 
palliative care services when compared to other serious illness populations.35 The lack of 
research and clinical attention to the palliative and end of life care needs of this young 
population is significant given high rates of mortality and symptom burden. In a randomized 
controlled trial of adults with heart failure, palliative care involvement was associated with 
patient improvements in quality of life and spiritual well-being and decreases in symptoms of 
anxiety and depression.41 Others have noted palliative care involvement to be associated with 
improved patient and family satisfaction, enhanced communication with medical providers, 
increased access to community and social supports, and reduced medical costs.42 As such, it 
has been recommended that interdisciplinary supportive care be provided throughout the heart 
failure course with early engagement in advance care planning (i.e., discussing one’s wishes 

Page 2 of 4 
 
and surrogate decision maker if unable to engage in medical decision making) due to 
challenges with prognostication and risk of sudden death in heart failure populations.43  
Communication in Heart Failure. Despite consensus statement43 and other professional 
guidelines that recommend all adults with CHD participate in advance care planning,44 minimal 
prognostic, advance care planning and end of life care focused communication occurs across 
heart failure populations. Among adults with CHD, only 1% recalled discussing advance care 
planning with their medical team even though 78% of the participants believed their healthcare 
providers should initiate end of life decision making discussions early in the disease course.45 
Only 37% of family members of adults who died of heart failure were aware of their loved one’s 
poor prognosis. Few were informed of the imminent death of their family member; as such, over 
1/3 of the patients died alone.46 Communication about end of life care preferences occurs even 
less frequently among pediatric heart failure populations. Study PI recently conducted an 
international survey of multidisciplinary pediatric heart failure providers. Initial data analysis of 
82 respondents suggests that providers rarely or never discuss death/dying, advance care 
planning or prognosis with pediatric patients with heart failure/heart transplant (ages 4-24 
years). Respondents indicated a high level of discomfort in discussing these topics and noted 
that additional barriers include the patient/parent(s) being unaccepting of the prognosis, the 
patient/parent(s) having unrealistic expectations for treatment, and there being an unknown 
prognosis/disease trajectory. These barriers should not prevent us from addressing the end of 
life care needs of our AYA patients and families. Yet, the majority of AYAs with serious illnesses 
report feeling inadequately informed and insufficiently involved in their health care.47,48 Studies 
in other illness groups suggest that AYAs desire prognostic information early in their disease 
course. Many want to be made aware of their options and engage in shared decision making 
with caregivers.49,50 Although the degree to which youth desire active participation in 
discussions about death and dying varies, the majority of AYAs with life-threatening illnesses 
describe a preference to discuss their end of life care wishes – and to do so prior to becoming 
acutely unwell.51 In a randomized controlled trial of a family-centered advance care planning 
intervention among AYAs with cancer, intervention group family participants reported increased 
understanding and awareness of AYA end of life wishes.52 This is important given that others 
have documented discordant end of life care preferences among AYAs and their parents.51 In 
addition, AYAs in the intervention group were more likely than controls to object to invasive 
interventions at end of life.52 In a similar intervention trial among young people with HIV, 
engagement in advance care planning was associated with increased positive emotions 
following the discussion and reduced decisional burden.53,54 Others have suggested that youth 
engagement in advance care planning is associated with increased likelihood of home death 
and reductions in invasive interventions at end of life.50 To the best of our knowledge, no studies 
outside our pilot work have sought to understand the palliative and end of life care needs of 
AYAs with heart failure.  
STUDY AIMS 
Based upon previous research by Dr. Cousino (PI) and her study team (HUM00157016), this 
study will pilot a physician-directed communication focused intervention, WE CHATT. The 
development of WE CHATT was informed by patients and their caregivers, with the ultimate 
goal of improving patient-centered communication for young people with advanced heart 
disease. The primary outcome of this pilot study is determining feasibility and acceptability, 
however, in the future, WE CHATT aims to (1) improve patient-centered communication with 
young people with advanced heart disease and (2) increase physician comfort in 
communicating with young people themselves regarding their communication needs and 
preferences.  
METHODS 

Page 3 of 4 
 
Recruitment and Sample   
 
Physicians. A total of 20 physicians will be recruited. 10 will be randomized to participate 
in the intervention arm and 10 will be randomized to the control arm. Physician 
participants will be recruited from the Division of Pediatric Cardiology at the University of 
Michigan, which is currently comprised of 37 attending physicians and 16 fellows. All 
physicians with dedicated clinical effort will be eligible. Eligible physicians must 
anticipate remaining on staff >1 years. Study PI (Cousino) and Co-I (Schumacher) will 
co-lead recruitment efforts via presentation(s) of study objectives and procedures at 
faculty/fellow meetings. Cardiology faculty and fellows were informally surveyed 
regarding interest in participating in the study. Over 90% of faculty and fellows 
expressed openness to participating in the study. Thus, the recruitment goal of 20 
physician participants is feasible.  
 
Patient/Caregivers. Patients (12-24 years) with heart failure symptoms meeting criteria 
for New York Heart Association (NYHA) Class II - IV heart failure will be eligible (i.e., 
limitations in physical activity, fatigue, palpitations, dyspnea). One parent/caregiver of 
patient participants meeting inclusion criteria will also be eligible. This patient age range 
was selected in accordance with research in other illness groups,48,49,51 is consistent with 
the World Health Organization’s definition of adolescent/young adult (AYA), and fulfills 
the Institute of Medicine’s need for research on AYA end of life care preferences and 
decision making involvement.29 This age range also captures the average age (17 years) 
of patients with congenital heart disease.38 A new patient meeting the above criteria in 
any hospital setting (inpatient, outpatient cardiology clinic, emergency room) being cared 
for by a participating physician will be eligible for the study. Patients with significant 
cognitive/developmental delay with potential to impact study participation will be 
excluded from the study due to the focus on physician-youth communication. Parents 
and parent/caregivers who are non-English speaking will be excluded from this pilot 
study.  
 
Compensation for Time. Intervention arm physician participants will receive a $100 gift 
card for their time to complete surveys, attend intervention training, and engage in 
intervention with patient participants. Control arm physician participants will receive a 
$25 gift card for their time completing surveys. All patient and parent/caregiver 
participants will receive a $25 gift card for their time completing surveys.  
 
Procedures 
 
Intervention Arm. The WE CHATT communication-tool was developed based upon 
mixed-methods research and stakeholder engagement (patients, parents, physicians, 
nurses, hospital leadership) led by study PI, Dr. Cousino, over the past decade. It 
involves the collaborative completion of a 2-page communication preferences document 
between a primary physician and an adolescent/young adult patient. Intervention arm 
physicians will participate in a 1-hour training led by study PI, Dr. Cousino, featuring 
didactic, multimedia, and experiential-based learning to support their facilitation of the 
WE CHATT intervention with patients.   
 
Control Arm. Physicians randomized to the control arm will not receive training in the WE 
CHATT communication intervention. Usual/standard care will be provided.  
 

Page 4 of 4 
 
Descriptive Measures. All physician participants will be asked to complete a 
background/demographic questionnaire (e.g., age, years of practice, previous communication 
training). Baseline and post-intervention completion of a previously used/published measure of 
physician comfort in communicating with patients and families, particularly around difficult topics 
(i.e., prognosis), will also be completed. Medical chart review will be completed to gather patient 
demographics and basic medical history, which will be used to define the study sample.  
 
Outcome Measures.  
 
Physician Measures. Intervention-arm physician participants will complete an 
investigator-designed Likert-rating and open-ended question survey assessing 
intervention satisfaction, ease of intervention administration/completion, time to complete 
WE CHATT intervention with patient, barriers/feedback specific to WE CHATT, and 
knowledge gained/perceived impact on practice.  
 
Patient/Caregiver Measures. Intervention-arm patient and caregiver dyads will complete 
an investigator-designed Likert-rating and open-ended question survey assessing 
intervention satisfaction, ease of intervention administration/completion, time to complete 
WE CHATT intervention with physician, barriers/feedback specific to WE CHATT, and 
knowledge gained/perceived impact on their medical care. All participating patients and 
parents will complete the self-administered 18-item Service Evaluation Questionnaire49 
as an assessment of healthcare satisfaction, which has been used in similarly aged 
samples.50 Patient and caregiver versions of previously validated survey tools of trust in 
physician (PediTIPS) and perceived empathy (CARE measure) will also be completed.  
 
 
Analysis Plan. Paired samples T-Test will be employed within the intervention arm to compare 
mean physician comfort, mean patient/family satisfaction, mean trust in physician, and mean 
perceived empathy. ANCOVA will be used to examine group differences in physician comfort, 
patient/family satisfaction, trust in physician, and perceived empathy. Frequencies, percentages 
and means will be calculated to describe physician, patient and family satisfaction with the WE 
CHATT intervention.  
 
 
LIMITATIONS  
 
Non-English speaking participants will be excluded from Study 1, limiting examination of cultural 
influences on end of life care preferences. Both physician fellows and attending physicians will 
be included as participants to ensure the recruitment goal of 20 is met for Study 2. We 
recognize that fellows are unlikely to have as much experience in patient communication as 
attending physicians, however, at our site, fellows often initiate difficult and advance care 
planning discussions given their primary roles in the cardiac intensive care unit. Others have 
included both fellows and attending physicians in their healthcare communication research.5,6