Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial
Phase: NA
Conditions: Chronic Disease, Neoplasm Metastasis, Lung Neoplasm, Pulmonary Disease, Chronic Obstructive, Heart Failure, Congestive, Liver Cirrhosis, Kidney Failure, Chronic, Multiple Organ Failure, Health Care Quality, Access, and Evaluation, Intensive Care Units, Palliative Care, Health Services, Palliative Care, Patient Care, Lung Diseases, Cerebrovascular Disorders, Brain Injuries
Sponsor: University of Washington

 
 
 
FACILITATING COMMUNICATION STUDY (FCS2)  
Protocol Number: UW STUDY00005369 
National Clinical Trial (NCT) Identified Number: NCT03721952 
 
Co-Principal Investigators: Ruth A. Engelberg PhD, Claire J. Creutzfeldt MD 
Sponsor: University of Washington School of Medicine 
 
Grant Title: Evaluating Effectiveness of a Communication Facilitator to Reduce 
Distress and Improve Goal Concordant Care for Critically Ill Patients and Their 
Families: A Randomized Trial 
Grant Number: R01NR018161 
Funded by: NINR 
 
Version Number: v.6 
7 June 2024 [10 October 2024] 
 

NIH Protocol Template for Behavioral and Social Sciences Research Involving Humans 
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes agreement by the 
recipient that no unpublished information contained herein will be published or disclosed without prior 
approval of the Principal Investigator or other participating study leadership and as consistent with the NIH 
terms of award.  
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 2 
1 
PROTOCOL SUMMARY ............................................................................................................................... 3 
1.1 
Synopsis ................................................................................................................................................ 3 
1.2 
Schema ................................................................................................................................................. 5 
1.3 
Schedule of Activities .......................................................................................................................... 5 
2 
INTRODUCTION ............................................................................................................................................ 6 
2.1 
Study Rationale .................................................................................................................................... 6 
2.2 
Background........................................................................................................................................... 6 
2.3 
Risk/Benefit Assessment .................................................................................................................... 7 
2.3.1 
Known Potential Risks ..................................................................................................... 7 
2.3.2 
Known Potential Benefits ................................................................................................ 7 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 9 
4 
STUDY DESIGN ........................................................................................................................................... 12 
4.1 
Overall Design .................................................................................................................................... 12 
4.2 
Scientific Rationale for Study Design.............................................................................................. 16 
4.3 
Justification for Intervention ............................................................................................................. 17 
4.4 
End-of-Study Definition ..................................................................................................................... 18 
5 
STUDY POPULATION ................................................................................................................................ 18 
5.1 
Inclusion Criteria ................................................................................................................................ 18 
5.2 
Exclusion Criteria ............................................................................................................................... 20 
5.3 
Lifestyle Considerations .................................................................................................................... 20 
5.4 
Screen Failures .................................................................................................................................. 20 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 20 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 25 
6.1 
Study Intervention(s) or Experimental Manipulation(s) Administration ...................................... 25 
6.1.1 
Study Intervention or Experimental Manipulation Description ................................. 26 
6.1.2 
Administration and/or Dosing ....................................................................................... 27 
6.2 
Fidelity ................................................................................................................................................. 27 
6.2.1 
Interventionist Training and Tracking .......................................................................... 28 
6.3 
Measures to Minimize Bias: Randomization and Blinding ........................................................... 28 
6.4 
Study Intervention/Experimental Manipulation Adherence.......................................................... 28 
6.5 
Concomitant Therapy ........................................................................................................................ 28 
6.5.1 
Rescue Therapy ............................................................................................................. 29 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................... 29 
7.1 
Discontinuation of Study Intervention/Experimental Manipulation ............................................. 29 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 29 
7.3 
Lost to Follow-Up ............................................................................................................................... 29 

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STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 30 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 30 
8.2 
Safety Assessments .......................................................................................................................... 31 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 31 
8.3.1 
Definition of Adverse Events ........................................................................................ 31 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 31 
8.3.3 
Classification of an Adverse Event .............................................................................. 31 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 32 
8.3.5 
Adverse Event Reporting .............................................................................................. 33 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 33 
8.3.7 
Reporting Events to Participants ................................................................................. 33 
8.3.8 
Events of Special Interest ............................................................................................. 33 
8.3.9 
Reporting of Pregnancy ................................................................................................ 33 
8.4 
Unanticipated Problems .................................................................................................................... 33 
8.4.1 
Definition of Unanticipated Problems .......................................................................... 33 
8.4.2 
Unanticipated Problems Reporting .............................................................................. 34 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 34 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 34 
9.1 
Statistical Hypotheses ....................................................................................................................... 34 
9.2 
Sample Size Determination .............................................................................................................. 35 
9.3 
Populations for Analyses .................................................................................................................. 35 
9.4 
Statistical Analyses............................................................................................................................ 36 
9.4.1 
General Approach .......................................................................................................... 36 
9.4.2 
Analysis of the Primary Endpoint(s) ............................................................................ 36 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 37 
9.4.4 
Safety Analyses .............................................................................................................. 37 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 37 
9.4.6 
Planned Interim Analyses ............................................................................................. 37 
9.4.7 
Sub-Group Analyses ..................................................................................................... 37 
9.4.8 
Tabulation of Individual Participant Data .................................................................... 38 
9.4.9 
Exploratory Analyses ..................................................................................................... 38 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 38 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 38 
10.1.1 
Informed Consent Process ........................................................................................... 38 
10.1.2 
Study Discontinuation and Closure ............................................................................. 39 
10.1.3 
Confidentiality and Privacy ........................................................................................... 39 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 40 
10.1.5 
Key Roles and Study Governance .............................................................................. 40 
10.1.6 
Safety Oversight ............................................................................................................. 41 
10.1.7 
Clinical Monitoring .......................................................................................................... 41 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 41 

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10.1.9 
Data Handling and Record Keeping ............................................................................ 41 
10.1.10 
Protocol Deviations ........................................................................................................ 42 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 42 
10.1.12 
Conflict of Interest Policy .............................................................................................. 43 
10.2 
Additional Considerations ................................................................................................................. 43 
10.3 
Abbreviations and Special Terms ................................................................................................... 43 
10.4 
Protocol Amendment History ........................................................................................................... 45 
11 
REFERENCES ............................................................................................................................................. 47 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 
21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form(s) must 
be obtained before any participant is consented. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form(s) 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances that 
this study will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable US 
federal regulations and ICH guidelines, as described in the Statement of Compliance above. 
 
Principal Investigators: 
Signed: 
 
Date: 
June 7, 2024 
 
Name:  Ruth A. Engelberg 
 
Title: 
Research Professor of Medicine 
Affiliation: University of Washington 
Address: 325 Ninth Avenue, Mailstop 359765, Seattle, Washington 98104 
Telephone: 206-744-9523 
Email: rengel@uw.edu 
 
 
Signed: 
Date: 
October 10, 2024 
 
Name:  Claire J. Creutzfeldt 
 
Title: 
Associate Professor of Neurology 
Affiliation: University of Washington 
Address: 325 Ninth Avenue, Mailstop 359775, Seattle, Washington 98104 
Telephone: 206-744-3251 
Email: clairejc@uw.edu 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
Title: 
Evaluating effectiveness of a communication facilitator to reduce 
distress and improve goal concordant care for critically ill patients and 
their families: A randomized trial 
Grant Number: 
R01NR018161 
Study Description: 
This study is a randomized clinical trial of an intervention to improve 
outcomes for patients and their family by using ICU nurse facilitators to 
support, model, and teach communication strategies that enable patients 
and their families to secure care in line with patients’ goals of care over 
an illness trajectory, beginning in the ICU and continuing to care in the 
community. 
Objectives*: 
 
The long-term objectives of this study are to evaluate, implement, and 
disseminate a model of care that ensures patients with critical illness 
receive care that is concordant with their goals over time, and across 
settings and providers. 
 
Specific Aims: 
1. Evaluate the effectiveness of an innovative communication facilitator 
on patient- and family-centered outcomes after critical illness, beginning 
with a critical care hospitalization and continuing through transitions in 
care. 
2. Evaluate the effectiveness for increasing healthcare value (defined as 
quality over costs), including reduced costs and cost-consequence ratios 
(dollars per unit change in depression, anxiety, or quality of life). 
3. Use qualitative methods to explore implementation factors 
(intervention, settings, individuals, processes) associated with improved 
implementation outcomes (acceptability, fidelity, penetration) to inform 
dissemination of this type of intervention to support patients and their 
families. [“Post-study interview”]  
4. Identify predictors of poor patient- and family-centered outcomes 
among patients admitted to the intensive care unit (ICU) with chronic 
illness with the goal of identifying those patients who are at high risk for 
poor outcomes and thus have the most opportunity to benefit from 
targeted supportive and palliative interventions. 
5. Explore patient, family, and clinician perspectives on the types, 
timing, and feasibility of supportive and palliative interventions that 
they believe would improve patient- and family-centered outcomes for 
patients with chronic illness via qualitative interviews. [“Post-study 
interview”] 
6. Explore the impact of the COVID-19 pandemic on the families of 
patients with critical illness, including those with and without COVID-
19 and identify opportunities to support family members through the 
restricted visitation that has resulted from the COVID-19 pandemic. 

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Endpoints*: 
Primary Outcome/Endpoint:  Family member symptoms of depression 
assessed with the Hospital Anxiety and Depression Scale (HADS) 
 
Secondary Outcomes/Endpoints: 
Family member symptoms of anxiety assessed with the Hospital 
Anxiety and Depression Scale (HADS); 
Concordance between the care patients want and the care they are 
receiving will be measured with two questions from the SUPPORT 
study; 
Subjective distress caused by a traumatic event assessed with the Impact 
of Event Scale-6 (IES-6); 
Family experience of quality of life at the end of life for patients with 
serious illness using the QUAL-E (Fam);  
Health care utilization during and after index hospitalization;  
 
Mediators: 
Participants' feelings of competence (self-efficacy) using the Perceived 
Competence Scale (PCS) 
 
Implementation Outcomes: acceptability, fidelity, penetration 
 
Other:  
Family member assessment of perceived financial stress using modified 
FACIT-COST instrument 
Study Population: 
Patients: adult, seriously ill, admitted to ICU; Seattle Washington: 
N=376 
Family: adult, caregivers to patients: N=564 
Clinicians/Administrators: adult, key informants familiar with 
intervention and hospital systems; Seattle Washington: N=15 
Phase* or Stage: 
Phase II 
Description of 
Sites/Facilities Enrolling 
Participants: 
University of Washington Medicine Centers:  
1. Harborview Medical Center 
2. UWMC 
3. Northwest 
4. Valley Medical Center 
Description of Study 
Intervention/Experimental 
Manipulation: 
Facilitator-Based Intervention. Facilitators interact in person or by 
telephone with patients, family, and clinicians both during and following 
the patient's ICU stay for 3 months. In-person contacts include visits to 
patients' homes and/or care facilities; phone contacts include calls to 
patients, families and clinicians. Patients and families have access to 
facilitators through phone and email 5 days per week. Facilitators may 
attend clinic visits with patients. In addition to checking directly with 
patients/families during regular contacts, facilitators also access the 
electronic health record to ensure they have accurate information about 
appointments and treatment plans and to document key points for the 
clinical team. Facilitators encourage referral to inpatient or outpatient 
palliative care services when needs are identified. 
Study Duration*: 
60 months + no-cost extension 
Participant Duration: 
6 months 

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1.2 
SCHEMA  
 
 
 
 
 
 
 
1.3 
SCHEDULE OF ACTIVITIES  
 
 
 
 
 
 
Screening 
Enrollment 
Baseline 
Questionnaire 
Month 1 
Month 2-3 
Month 6 
Post-Activity  
 
 
EHR Review Eligibility 
X 
 
 
 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
 
 
RSQ 
 
 
X 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
Intervention - ICU 
 
 
 
X 
X 
 
 
 
Intervention - Acute Care 
 
 
 
X 
X 
 
 
 
Intervention - Community 
 
 
 
X 
X 
 
 
 
Outcome Evaluation 
 
 
 
 
 
 
 
 
Survey Check-in/Reminder  
 
X 
X 
X 
X 
X 
 
 
Questionnaire Administration 
 
 
X 
X 
X 
X 
 
 
Chart Abstraction 
X 
 
 
 
 
 
X 
 
Implementation 
 
 
 
 
 
 
 
 
Fidelity Assessments 
 
 
 
X 
X 
X 
X 
 
Qualitative Interviews 
 
 
 
 
 
 
X 
 
Regulatory 
 
 
 
 
 
 
 
 
Adverse Events Reporting 
 
X 
X 
X 
X 
X 
X 
 

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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
 
Critically ill patients and their families suffer a high burden of symptoms of depression, anxiety, and post-
traumatic stress due, in part, to fragmented medical care that is often poorly aligned with their goals. 
Fragmented care includes numerous transitions for patients and families across clinicians and across 
settings, starting in the intensive care unit (ICU) and extending to acute care, skilled nursing facilities, or 
home. As illness progresses across these transitions, patients and families struggle to navigate the 
spectrum of goals of care, to match their values and goals with treatments, to communicate their goals 
to their clinicians, and to make difficult medical decisions without letting unmet emotional needs caused 
by distress interfere. Poor communication, exacerbated by transitions across the multiple clinical teams, 
compounds an already stressful experience for patients and their families. Using a randomized trial, this 
study proposes to evaluate an innovative model of care in which ICU nurse facilitators support, model, 
and teach communication strategies that enable patients and families to secure care in line with their 
goals over an illness trajectory.  [Aims 1-3][R01] 
 
Nested within this study, we will also investigate the personal financial stress that critically ill patients and 
their family members experience during and after a stay in the ICU.  Although it is recognized that patients 
and family members experience financial stress during and after critical illness, little is known about how 
to address this type of stress. Through a novel, validated instrument to measure financial stress, and 
patient, family member and clinician interviews, we will assess causes of financial stress, the degree to 
which financial concerns cause distress, and attitudes towards potential services that could possibly 
reduce financial distress.   [Aims 4-5][K23] 
 
Additionally, in the current setting of the COVID-19 pandemic during which families are restricted from 
visiting their loved ones in the ICU, we will adapt this model of care to rely on distant contacts 
(phone/video), rather than in-person interactions, by ICU nurse facilitators to support, model and teach 
communication strategies that enable patients and families to secure care in line with the patient’s goals 
over an illness trajectory. [Aim 6] 
2.2 
BACKGROUND  
 
In our prior Phase II trial (Family Communication Study, UW IRB#33584), an earlier version of this 
intervention reduced symptoms of depression among family of critically ill patients and reduced hospital 
length of stay and costs of care, even after accounting for costs of the intervention. This next study 
evaluates effectiveness of the intervention with three added improvements based on feedback from 
family members, as well as experience with the prior trial: 1) we identify high-risk critically-ill patients and 
their families early in the ICU stay and then support communication across all transitions in care extending 
beyond the ICU for 3 months; 2) the intervention engages clinicians who regularly staff the ICU and 
coordinates with post-ICU resources to enhance scalability and dissemination; and 3) we examine factors 
that can impede or facilitate implementation and dissemination of this or similar interventions in the 
future.  
 
Our prior work on financial stress suggests that the prevalence of finance-related stress is high and 
persistent among patients requiring intensive care and their families, and this stress is a mediator of 

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symptoms of anxiety and depression.  This study will allow us to better understand contributors to this 
stress and potential interventions that might help reduce financial stress for patients and their family 
members. 
 
Our clinical experience working in the hospital during the COVID-19 pandemic is that family members are 
under tremendous stress caused by the pandemic and the visitation restrictions.  In addition, clinicians 
are also stressed by the workload, the family visitation restrictions, and concerns for their own health.  In 
this context, we need to identify ways to support patients, family members, and clinicians. 
2.3 
RISK/BENEFIT ASSESSMENT  
2.3.1 KNOWN POTENTIAL RISKS  
 
This research has been acknowledged as “minimal risk” by the IRB of record.  
 
There is a potential risk for stress and discomfort among patients and family subjects because of the focus 
on sensitive health information at a stressful time, including discussions with the facilitator and clinicians 
about goals of care at the end of life and decisions that may be made at that time. Questions about goals 
of care and preferences for palliative care and end-of-life care are part of the questionnaire items and 
outcome measures.  
 
Family member subjects may be upset or distressed by receiving a survey after the patient’s death that 
addresses his or her own personal health and feelings. In order to ensure that families have adequate 
time to process their loved one’s death, this survey will be sent on the same 1-3-6 month schedule but 
with an interval of at least 1 month following the patient’s death.  
 
Based on our prior experience with this intervention, this risk is minor and concerns by participants 
infrequent. 
 
The potential risks to all subject groups include perceived or real invasion of privacy, and risks of the 
perception of coercion that may be associated with participation. Subjects will be informed that their 
questionnaire and interview responses will be kept confidential by the research staff. Interview subjects 
will additionally be notified that hospital officials and supervisors will not have access to any outcome 
evaluations or feedback that might be linked to individual clinicians. 
 
There is the risk of a breach of confidentiality.  
 
There is the potential for randomization to the control/comparator arm to cause dissatisfaction for 
subjects who desire to have the facilitator intervention. If this concern arises, we will explain the principle 
of randomized trials and the reasons that it is essential to honor the randomization procedures in order 
to conduct a legitimate study. 
 
Risks will be explained during recruitment and the informed consent procedures. Participation is voluntary 
and participants may withdraw from the study at any time for any reason. 
2.3.2 KNOWN POTENTIAL BENEFITS  
 

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There may be some benefit to the participants enrolled in the intervention group. The availability of the 
communication facilitators and the services they will provide will likely be of assistance during the hospital 
stay and during transitions following the hospital stay.  Participants in the control arm are not likely to 
benefit from the study’s activities. Participants in the comparator group with access to a resource person 
may receive some benefit by the help and support the resource person can provide. There are no 
anticipated individual benefits in regard to completion of questionnaires or interviews.  
 
If successful, this research activity will provide a valuable model to improve the quality of care for patients 
and their families during and after critical illness through the use of a feasible and generalizable 
communication intervention that identifies and communicates the goals of care across the spectrum of 
goals from curative and restorative to palliative care.  The goals of the intervention are to reduce the 
psychological stress of critical care and transitions during and after critical care, improve goal-concordant 
care, and improve quality of life while simultaneously reducing unwanted high-intensity care at the end 
of life. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
All subjects will be informed of the research nature of the activity, including the composition of specific 
questionnaire items, the estimated time required to complete the activities, and that participation is 
voluntary. All study personnel will be trained in the protection of human subjects, HIPAA regulations, and 
will sign confidentiality agreements. We will clarify and ensure that questionnaires and interviews are 
confidential, and results will not be shared among patients, family groups, or other care providers. 
Identifying information and de-identified study records will be kept in locked file cabinets and password 
protected computers. All study databases will be maintained on password protected computers and 
routinely backed up to password protected files. Identifying information will be deleted at the earliest 
possible date and in compliance with University of Washington guidelines. Data presentations will include 
only group data and will be presented in a way that ensures individual participants cannot be identified. 
If respondents may be identified by a specific subgroup analysis due to the low numbers of these types of 
respondents (e.g., patients aged >90), these subgroup data will not be presented in any format. 
 
For all participants, it will be emphasized that participation is voluntary, that all steps involved with 
participation are voluntary, that they are allowed to refuse to complete any activity or to answer any 
question they are asked, and that they may withdraw from the study or any study procedures at any time 
without any loss of rights or benefits to which they are otherwise entitled and without losing status or 
standing within the institution. Additionally, subject payments and tokens of appreciation will be kept 
small to minimize potential coercion or the appearance of coercion. 
 
All potential participants will be provided contact information for the IRB of record (University of 
Washington Human Subjects Division) to register complaints or other problems. Adverse events will be 
reported by the principal investigators to the IRB and the chair of our Data and Safety Monitoring 
Committee (DSMC) at the time of occurrence. The DSMC will modify or stop the study if any such 
complaints represent a legitimate concern about the study procedures or methods. 
 
Our goal in this randomized trial is to evaluate, implement, and disseminate a model of care that ensures 
patients with critical illness receive care that is concordant with their goals over time, and across settings 
and providers. This model of care uses a nurse-led communication facilitator who will assist patients and 
their families in identifying, communicating and enacting their goals of care, and will be feasible for 
implementation in routine clinical practice. A test of this intervention will not only advance the science 

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and practice of supporting patients with critical illness and their families by reducing the distress caused 
by critical illness and fragmented healthcare, but it will also address key knowledge gaps to improve 
outcomes for the critically ill and their families. 
3 
OBJECTIVES AND ENDPOINTS  
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
Assessing family member 
symptoms of depression over 
time, from baseline through 6 
months 
Family member symptoms of 
depression assessed with the 
Hospital Anxiety and Depression 
Scale (HADS-D) subscale  
The HADS has become standard 
for ICU and post-ICU studies. It is 
a reliable and valid 14-item, 2-
domain (anxiety and depression) 
tool used to assess symptoms of 
psychological distress. Seven 
items evaluate depression. Each 
item is scored on a 4-point scale 
(ranging from 0-3) with scores 
ranging from 0-21. HADS has 
been used in over 700 studies 
with evidence of reliability, 
validity and responsiveness 
among critically ill patients and 
their family. 
Secondary 
 
 
Assessing family member 
symptoms of anxiety over time, 
from baseline through 6 months 
Family member symptoms of 
anxiety assessed with the 
Hospital Anxiety and Depression 
Scale (HADS-A) subscale  
The HADS has become standard 
for ICU and post-ICU studies. It is 
a reliable and valid 14-item, 2-
domain (anxiety and depression) 
tool used to assess symptoms of 
psychological distress. Seven 
items evaluate anxiety. Each 
item is scored on a 4-point scale 
(ranging from 0-3) with scores 
for ranging from 0-21.  
Goal-concordant care 
Concordance between the care 
patients want and the care they 
are receiving will be measured 
with two questions from the 
SUPPORT study. The first defines 
patients' preferences: "If the 
patient had to make a choice at 
this time, would the patient 
prefer a course of treatment 
focused on extending life as 
much as possible, even if it 
means having more pain and 
discomfort, or would the patient 
The outcome is a dichotomous 
variable of whether the 
preference matches the report 
of care received. Although this 
creates a "false dichotomy" in 
that many patients want both, 
this "forced choice" helps 
identify patients' top priority. 
Based on prior studies, we 
expect only 50-60% of controls 
will report goal-concordant care. 
Items completed by family 
respondents. 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
want a plan of care focused on 
relieving pain and discomfort as 
much as possible, even if that 
means not living as long?" The 
second question assesses 
perceptions of current treatment 
using the same two options.  
Post-traumatic stress (civilian) 
Subjective distress caused by a 
traumatic event assessed with 
the Impact of Event Scale-6 (IES-
6). 
The IES-6 uses 6 self-report 
items to assess subjective 
distress caused by a traumatic 
event. Items are rated on a 5-
point scale ranging from 0 ("not 
at all") to 4 ("extremely"). 
Family experience of quality of 
life at the end of life for patients 
with serious illness 
Measure of family experience of 
patients with serious illness 
using the QUAL-E (Fam). 
Outcomes will be focused three 
of the instrument’s subscales: 
Relationship to Healthcare 
Providers, Sense of Completion, 
and Preparation Issues 
The QUAL-E (Fam) is a validated 
~17-item companion instrument 
to the patient QUAL-E measure 
of quality of life at the end of 
life. 
Healthcare Costs and Utilization 
Index hospitalization length of 
stay; subsequent hospitalization 
and ICU admissions; palliative 
care consults; outpatient 
visits/Emergency Department 
visits (as available). 
We will measure hospital 
readmission after initial hospital 
discharge through the electronic 
health record (EHR), institutional 
billing systems and, 
patient/family self-reports. All 
hospitals are in one system 
facilitating data collection. By 
using all three sources for data, 
we will capture hospitalizations 
regardless of healthcare system. 
Our primary focus will be 
readmission within 30 days as 
this is a national standard, but 
we will also collect data from the 
EHR and from patient/family 
interviews to record all 
readmissions, emergency 
department visits, clinic visits, 
inpatient and outpatient 
palliative care consults, and 
home care over 6 months. All 
occasions of healthcare use will 
be confirmed through chart 
review and valued using the 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Medical Expenditure Panel 
Survey and the Healthcare Cost 
and Utilization project, with 
additional information from 
Institutional financial systems 
will be used to capture costs of 
care rather than charges. 
Tertiary/Exploratory  
 
 
Key Implementation Factors 
Factors include: aspects of the 
intervention, inner and outer 
settings, individuals, and 
processes of care. 
Qualitative interviews after 
individual participation. 
Interviews will be guided by the 
Consolidated Framework for 
Implementation Research (CFIR) 
to explore the factors associated 
with implementation. Individual 
constructs within these domains 
were chosen to fit this specific 
intervention and context. 
Key Implementation Outcomes 
Outcomes include: acceptability, 
fidelity, and penetration of the 
intervention. 
Qualitative interviews after 
individual participation. 
Interviews will also explore three 
key implementation outcomes 
that will guide future 
dissemination of the 
intervention. 
Perceived Competence  
Participants' feelings of 
competence assessed with 
Perceived Competence Scale 
(PCS) 
PCS is a short, 4-item 
questionnaire assessing 
participants' feelings of 
competence. Items can be 
worded differently for different 
target behaviors. Validity was 
established in a study of medical 
students, and then in studies of 
diabetes self-management. 
Cronbach's alpha has 
consistently been above 0.80 in 
multiple studies. The scale has 
been used in several studies. The 
mean of 4 items is used as the 
scale score. The 4 items have 
also been used to form a latent 
variable and assessed for change 
over time. Responses range from 
"Not at all true" (1) to "Very 
True" (7); higher score on the 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
latent variable would indicate 
greater competence. 
Financial Toxicity  
Family member assessment of 
perceived financial stress will be 
measured with a modified FACIT 
COST (Comprehensive Score for 
Financial Toxicity) instrument.  
The 11-item COST instrument 
has demonstrated reliability and 
validity in measuring financial 
toxicity. 
 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
 
This study is a single site, Phase II randomized trial of an intervention to improve outcomes for patients 
and their family by supporting, modeling, and teaching communication strategies that enable patients 
and their families to secure care in line with a patient’s goals over an illness trajectory, beginning in the 
ICU and continuing to care in the community.  
 
Aims 1 & 2 & 4 & 6 
Subject Identification/Recruitment: We will recruit within the ICUs of three hospitals that compose UW 
Medicine in the Puget Sound region. [Dropped 4th site January 2023, inactive.][See Section 5.5] 
 
Randomization: If patients and family agree to participate and are decisionally capable, they will complete 
informed consent procedures and HIPAA authorization. Randomization will occur after completion of the 
baseline questionnaire, with the patient as the unit of randomization. Randomization will occur in 
variable-sized blocks stratified by site using a computer-based algorithm.  Subjects assigned to the 
intervention arm will work with a communication facilitator and will complete assessments/measures; 
subjects assigned to the control arm will complete assessments/measures only. [See below for details on 
measures and data collection.] Family will be clustered under patients.   
 
Documentation:  A short study summary will be included in the patient’s electronic health record (EHR). 
This summary will be included for both the intervention and control patients.  
 
Control Arm/Usual Care: Family members of patients randomized to the control arm will complete the 
same study measures at all data collection points, but the facilitator will not be involved.  Instead, these 
subjects will be contacted prior to the follow-up questionnaires at 1-month, 3-months and 6-months from 
randomization. During the calls for these subjects, they will be asked if they have any questions about 
study procedures and be reminded about upcoming surveys. 
 
Information & Resources Provision Arm/Comparator: This new study arm is an adaptation to the 
Facilitator Protocol for use during the COVID-19 pandemic. For those randomized to “Control/Usual Care,” 
participation in this comparator arm will be available at the participant’s request. The goal of this 
comparison group is to offer family members a contact person for questions related to their loved one’s 
care. The resource person (trained study staff) will contact family members within 1-2 days of enrollment 
and randomization.  They will introduce themselves as a resource for finding or providing information in 

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this stressful and difficult time.  All contact will be by telephone or UW HIPAA-compliant Zoom on the 
following schedule: 
 
a. Within 1-2 days of randomization 
 
b. Within 1-2 days of transfer to acute care. 
 
c. Within 1-2 days of hospital discharge. 
The resource person is intended to provide information and help families connect with the right person 
at the hospital or on the patient's healthcare team to provide help and support. 
 
Intervention Administration: Intervention activities will be conducted with intervention subjects only. 
During the ICU stay, facilitators will interact in person by telephone or UW HIPAA-compliant Zoom with 
patients and family subjects, and those clinicians (physicians, nurses, social workers, spiritual care, etc.) 
involved with patients’ care.  Following the ICU stay, facilitators will interact with patients, family and 
clinicians in person and by phone or UW HIPAA-compliant Zoom for 3 months from randomization (when 
most first readmissions occur) or for 1 month after a patient death occurring in the first 3 months.  In-
person contacts, when possible, will include visits to patients’ homes and/or care facilities; phone or UW 
HIPAA-compliant Zoom contacts will include calls to patients, families and clinicians.  Facilitators will visit 
with or contact patients and families on the following schedule:  daily during the ICU stay, every 72 hours 
or more frequently on the acute care floor, weekly during the first month following hospital discharge, 
and twice monthly for the remaining intervention period (3 months from randomization). Facilitators will 
have the leeway to use their clinical judgment if additional contacts are needed and may extend the follow 
up period for up to 6 months from randomization if needed. Facilitators will carry a caseload of up to 20 
patients per facilitator per month.  
 
Facilitator Intervention:  After baseline data collection, the facilitator will begin providing the intervention 
to patients in the ICU and their families. The intervention will include communication activities such as: 
discussion of values using the Facilitated Values History, provision of educational and informational 
materials as needed, and support and mediation if conflicts arise among the family or between family and 
the clinical team. The facilitators will provide these activities in a manner consistent with the subjects’ 
preferred attachment styles that are assessed at baseline.  
 
During the patient’s hospitalization, the facilitators may enter notes in the EHR to relay information in the 
patient’s chart that is relevant to communication between patient/family and the clinical team, for 
example:  "The patient's daughter expressed questions about rehab;" or “The patient's son may be 
reluctant to ask questions, informing him about what to expect next may be helpful."  The facilitators also 
enter a Research Intervention Introductory note into the patient EHR so inform the clinical staff about 
their role with the patient/family. These notes will appear under “Chart Review/Notes/Type: Research 
Note” in the EHR system. Additionally, we will have signage in the hospital room noting that study 
facilitators are available for the patient enrolled in the intervention. The sign will mirror the note in the 
EHR. 
 
After the ICU stay, the facilitator will guide the patient and family through transitions to the acute care 
floor, discharge to home/rehabilitation or skilled nursing facility (SNF).  Outside the hospital in the 
community, the facilitator will be available to make visits to a SNF or rehabilitation unit and/or the 
patient’s home,  and participate in outpatient clinic visits. The primary mission of the facilitator at these 
transitional contacts will be to support, model, and teach the communication skills that advance self-
efficacy, outcome expectations, and behavioral capacity for goals-of-care discussions that will advance 
care in line with those goals and across transitions.  
 

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Intervention Fidelity:  We will record type (mode), frequency and duration of all facilitator contacts for 
each patient and family so that we will have this information to assess intervention fidelity as well as 
“dose.”  We will also ask participants for permission to periodically audio-record their visits with the 
interventionist. This procedure will assist in monitoring and maintaining intervention delivery. De-
identified transcripts may also be used for training future interventionists. 
 
Outcome Assessment:  Both intervention and control subjects will be asked to complete questionnaires. 
At baseline/enrollment, prior to the facilitator’s involvement, both intervention and control group 
subjects will meet or confer with the research staff who will distribute initial questionnaires. The 
questionnaires will be self-administered, although study staff will be available to provide assistance.  The 
study staff member collecting the baseline questionnaires will be able to notify the subjects about their 
randomization status at that time.   
 
Chart abstraction of patient data from EHR will include: age, sex/gender, Race, Ethnicity, primary 
diagnosis, secondary diagnoses and comorbidities, admission dates (e.g. hospital, ICU, acute care) , 
discharge dates (e.g. hospital, ICU, acute care), processes of care (e.g. care planning, transitions) , 
treatment intensity (e.g. receipt of CPR, use of mechanical ventilation), Referrals/Consults (e.g. palliative 
care) , data required to calculate APACHE II scores (e.g. lab values, Glasgow Coma Scale, medication 
dosage), outpatient healthcare utilization: number, type and dates of primary and specialty care visits, 
and date of death. Dates of death will also be collected from publicly available death certificate data. 
 
Family questionnaires will be completed at baseline, 1-month, 3-months, and 6-months post 
randomization. Questionnaires will contain measures including:   
• 
Relationship Scales Questionnaire (RSQ) – initial survey 
• 
Hospital Anxiety and Depression Scale (HADS) – initial and follow-up surveys 
• 
Concordance between the care patients want and the care they are receiving will be measured 
with two questions from the SUPPORT study.  The first defines patients’ preferences: “If the 
patient had to make a choice at this time, would the patient prefer a course of treatment focused 
on extending life as much as possible, even if it means having more pain and discomfort, or would 
the patient want a plan of care focused on relieving pain and discomfort as much as possible, even 
if that means not living as long?” The second question assesses perceptions of current treatment 
using the same two options. The outcome is a dichotomous variable of whether the preference 
matches the report of care received. Although this creates a “false dichotomy” in that many 
patients want both, this forced choice helps identify patients’ top priority. – initial and follow-up 
surveys 
• 
Single-Item health status question (SF-1): “In general, would you say your health is:  Excellent, 
Very good, Good, Fair, Poor” – initial survey and follow-up surveys 
• 
Single-Item health status question (SF-1): “In general, would you say your family member/friend’s 
health is:  Excellent, Very good, Good, Fair, Poor” – initial survey and follow-up surveys  (proxy for 
patient) 
• 
FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight) – initial survey and 
follow-up surveys (proxy for patient) 
• 
Preferred Role in Decision-Making – initial survey and follow-up surveys 
• 
Perceived Competence Scale (PCS) – initial and follow-up surveys 
• 
Impact Of Events Scale-Revised (IES-6) – follow-up surveys 
• 
Measuring the Quality of Life of Seriously Ill Patients (QUAL-E FAMILY) – initial and follow-up 
surveys 
• 
Comprehensive Score for Financial Toxicity (modified FACIT-COST) – follow-up surveys 

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• 
Healthcare Utilization – follow-up surveys (proxy for patient) 
• 
Intervention Assessment – follow-up surveys (intervention arm only); and  
• 
demographic items, including social support and health literacy (single item). 
 
Family of patients who die will receive after-death questionnaires at the usual schedule but at least 4 
weeks after the patient’s death. The after-death questionnaire contains: decision-making, FACIT-COST, 
QUAL-E FAMILY (revised), HADS, IES-6, SF-1 and demographic items.  
 
The research staff will contact both the intervention and control/comparator group subjects in person 
and by phone/text or email. for the evaluation phase. Participants will complete questionnaires at several 
timepoints: 1, 3, and 6 months after randomization. At each point after the initial questionnaire, they will 
complete the same measures (without demographics or relationship questionnaire) as well as information 
about subsequent patient healthcare utilization.  Although all questionnaires can be completed by phone, 
mail, or online, we will contact participants at each interval by phone/text or email. During those calls, 
study staff will administer the questionnaires or remind participants to complete questionnaires by mail 
or online.  
 
Participating family subjects of patients who die will receive after-death questionnaires 4 to 6 weeks after 
a patient’s death.  The purpose of the after-death questionnaires is to examine outcomes for Aim 1 
(psychological distress and quality of life).  We are collecting this information from bereaved family 
members because we would like to know if family members who report better outcomes in this regard 
did or did not work with a facilitator. The after-death questionnaire will be delivered to the family subject 
in place of the next follow-up questionnaire. For example, if the patient dies after two months from 
enrollment, the family member will receive the after-death questionnaire as their 3-month questionnaire; 
the family member will then receive a 6-month questionnaire as scheduled, but the number of items will 
be reduced as questions about interacting with the patient’s health care team will no longer be applicable. 
(See Section 5.2) 
 
Follow-up contacts will be done after the initial mailings of the questionnaire booklets to non-responders. 
The follow-up will consist of a reminder/thank you postcard after 10 days, and for the 3- and 6-month 
questionnaires, a second set of materials after 4 weeks if there has been no response in that time. For the 
6-month questionnaire, if there has been no response to the second set of materials after an additional 4 
weeks, we will send out one last questionnaire.  
 
At 6 months post-randomization, or at one month after the patient’s death, study staff will collect 
additional information from the patient’s electronic health record (EHR). Study staff will record healthcare 
use, disease characteristics and processes of care during and after the ICU stay, including treatment 
intensity (e.g. receipt of CPR, use of mechanical ventilation), transitions in care, and palliative care 
consults. Data will be abstracted using automated EHR data collection and “gold standard” manual 
abstraction using standardized methods for training and quality control.  
 
Aims 3 & 5 
Post-study Interviews: Included in the consent form will be a provision informing patient and family 
member subjects that they may be contacted at the end of their study involvement (after 6 months) to 
take part in a short, semi-structured interview to evaluate their study participation, and to explore 
feedback on the intervention and ways to improve the intervention delivery and implementation.  
Interviews will also ask how being in the ICU may add to a subject’s financial worries and how financial 
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penetration) that will guide future dissemination of the intervention.  To these ends, study staff will also 
recruit clinicians and hospital administrators familiar with the study to participate in a short feedback 
interview as well. The purpose and procedures for these clinicians (physicians and others) and 
administrators are the same as those for the patient and family subjects.  We anticipate that the study 
facilitators will be able to identify clinicians and administrators that they encountered during the course 
of the intervention activities.  
 
Patients, family, clinician & administrator interview participants will be selected using purposive sampling 
to ensure a diverse group based on race/ethnicity, age, gender, experience and, for clinicians, specialty 
and year of training. Subject interviews will be audio recorded, transcribed, and analyzed using thematic 
analyses. Subjects may participate even if they choose not to be audio recorded.  To ensure 
trustworthiness, interviewers will perform a “member check” of the results with prior participants (n=10 
to 15) selected for diversity of participant type. 
 
Interventionist feedback interviews will be recorded and transcribed. Subjects may participate even if they 
choose not to be audio recorded. 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Key communication problems that both patients and their families face include: 1) being unable to 
articulate their goals of care; 2) not having skills, confidence, and beliefs that communicating with multiple 
clinicians can lead to better outcomes; and 3) being too distressed to process information to make 
informed choices that are goal-concordant (i.e., treatment chosen is consistent with patient values). Our 
goal is to test the effectiveness of a nurse communication facilitator who will support, model, and teach 
communication skills and strategies to patients and families with the goal of ensuring goal-concordant 
care across transitions in clinicians, clinical teams, and care settings. Facilitators will target the following: 
1) improving patients’ and families’ self-efficacy for communicating with their clinicians by increasing their 
knowledge of their goals of care; they will also address negative emotion to improve patient and family 
members’ ability to absorb this knowledge; 2) fostering and modeling positive outcome expectations for 
effectively conveying goals of care to providers; they will support these outcome expectations by 
matching communication to patients’ and family members’ attachment and communication styles; and 
3) bolstering behavioral capability by modeling successful resolution of obstacles to goals of care 
discussions and mediating conflict. In addition, by clarifying goals of care, periodically reassessing these 
goals, and ensuring that goals transfer across transitions, this intervention can reduce psychological 
distress and harm caused by fragmented care. Importantly, the facilitator would not replace clinicians in 
our system, but would maximize the potential of our system to provide high-quality, patient- and family-
centered care. 
 
Prior studies have included some components of our intervention, including patient navigation, discharge 
planning, transitional care, care coordination, and case management. Although some showed reductions 
in re-hospitalizations, few have had a significant effect on psychological distress or other key patient-
centered outcomes. Also, a recent systematic review found few studies that addressed hospital-based 
programs to improve transitions and none that incorporated multiple transitions during and after the 
hospital. The authors conclude that “because of scant evidence, no conclusions could be reached on 
methods to prevent post-discharge adverse events.”1 Similarly, an AHRQ Evidence Report found existing 
interventions to improve continuity and transitions had moderate strength evidence for improving 
satisfaction, but low strength for other patient-reported outcomes or healthcare utilization.2-5 

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Importantly, a recent randomized trial examined palliative care-led ICU family conferences that were not 
well integrated with the ICU team, finding no improvement in family symptoms of depression or anxiety 
and increased symptoms of PTSD at 3 months.6  
 
Our intervention is different from these prior efforts in five four key ways. First, rather than focusing on a 
single transition, such as hospital discharge, or a single event, such as the family conference, we identify 
high-risk critically ill patients and their families early in the hospitalization and support communication 
across multiple transitions in clinicians, teams, and settings. Second, the intervention is designed to help 
support communication across the full range of goals of care from curative and restorative care through 
palliative and end-of-life care, thereby reducing stress and readmissions by clarifying goals of care. Third, 
this intervention is built on social cognitive theory, a well-supported theory for behavior change; 
intervention components are designed to enhance self-efficacy, outcome expectations and behavioral 
capability of patients and families by ensuring that patients, families, and clinicians understand and 
implement the patient’s goals of care. Fourth, we adapt a previously developed decision support tool in 
the novel context of a facilitator to support its use. Finally, the intervention is designed to synergize, rather 
than compete, with existing resources such as discharge planning and care coordination. 
 
• Importance of family psychological distress as outcomes: The importance of improving outcomes for 
family caregivers and the value this brings to patient outcomes is well-established. When family members 
suffer from the burden of critical illness, patients also suffer. Much of the suffering comes from the 
difficulties of surrogate decision-making and the fact that most critically ill patients don’t have decisional 
capacity. Interventions that reduce family member distress also improve the care they can provide. In 
addition, stress extends beyond the ICU as family bear a significant burden of caregiving after the ICU. As 
many as 20-60% of families and patients suffer a high burden of psychological symptoms during and after 
the ICU. Improving communication is key because poor communication worsens distress, and 
interventions that improve communication reduce distress. Further, caregiver stress increases healthcare 
use and reduces quality of life. Although we will assess symptoms in patients and family, most critically ill 
patients are unable to participate. Thus, we focus on family member symptoms as the primary outcome. 
 
• Key role of goal-concordant care as an outcome: Care that is concordant with patients’ goals is a critical 
component of high quality, patient-centered care for all patients, but especially those with serious illness. 
Therefore, a key outcome for an intervention designed to improve communication about goals of care is 
whether patients receive the care they want. For critically ill patients, decisions about goals of care are 
often made by surrogate decision-makers. We will assess goal concordance using two validated questions 
from the landmark SUPPORT trial. The first defines patient preferences for either extending life or 
ensuring comfort (from the patient or family perspective). The second assesses patient and/or family’s 
perceptions of current treatment. The outcome will be a dichotomous variable of concordance between 
these two items. 
 
• The role of cost-consequences: With the increasing cost of healthcare, interventions that ensure value–
high quality, cost-effective care–are essential. However, traditional cost-effectiveness analyses have 
important limitations in the context of palliative care, because of the limited potential for a traditional 
survival effect. Therefore, we use a more comprehensive cost-consequence framework, to test the 
hypothesis that the intervention reduces costs while improving patient and family outcomes (i.e., 
consequences). 
4.3 
JUSTIFICATION FOR INTERVENTION 

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Although navigators or facilitators have been evaluated in some settings, our intervention is unique by its 
inclusion of nurse facilitators with novel training that supports, models and teaches communication skills 
to patients and family facing critical illness. This intervention will be implemented both during and after 
critical illness and addresses key gaps identified in past systematic reviews by: 1) beginning early in the 
high stress time of critical illness and following patients after ICU; 2) focusing on communication about 
goals of care; and 3) targeting a diverse population (e.g. age, diagnoses, SES) to enhance generalizability, 
scalability, and cost-effectiveness. 
 
Despite advances in our ability to provide life-sustaining treatments and manage chronic illness, our ability 
to integrate high-quality palliative care remains limited. Our failure to integrate palliative care stems, in 
part, from our system’s inability to identify, periodically reassess, and consistently communicate patients’ 
informed goals of care. For this reason, important advances in palliative care do not reach many patients 
with serious illnesses. One fifth of deaths in the US occur in the ICU, highlighting the importance of 
identifying and implementing patients’ goals of care in this setting. As demonstrated in a landmark 
randomized trial of early palliative care for patients with lung cancer,7 improving care for patients with 
serious illness requires that discussions about goals of care start early and continue across all settings. 
However, a recent trial of palliative care-led ICU family meetings (with little integration with the ICU team) 
was associated with worse family outcomes.6 Another recent trial showed worse family outcomes with a 
condolence letter after the ICU.8 Both trials had unintended consequences, highlighting the importance 
of rigorous evaluation. We hypothesize that early and integrated goals-of-care conversations will allow 
seamless and coordinated transitions across clinicians and settings, and we propose a rigorous evaluation 
to explore mechanisms and potential unintended consequences. Our facilitator is an ICU nurse – a type 
of clinician present in all ICUs who can be trained for this role and has clinical expertise to incorporate 
best practices for transitions enhancing scalability. 
4.4 
END-OF-STUDY DEFINITION 
 
A family member participant is considered to have completed the study if he or she has contributed 
outcome data for the 1-, 3- and 6-month follow-up assessments. Some family participants will also 
contribute to a qualitative interview at the end of the 6-month follow-up period 
 
A patient subject is considered to have completed the study when all data collection (chart abstraction) 
has been completed at the end of the 6-month follow-up period.  
 
A clinician or administrator interview subject is considered to have completed the study at the conclusion 
of any ‘member check’ conducted after their single qualitative interview. 
 
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
 
--PATIENTS--  
Eligible patients will be those who are 18 years of age or older, English-speaking, with a chronic life-limiting 
illness suggesting a median survival of approximately 2 years or a severe acute illness with a risk of hospital 
mortality of at least 15%.  

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• Chronic life-limiting illnesses include:   
o cancer with a poor prognosis (e.g. metastatic cancer);  
o chronic pulmonary disease (e.g. COPD or restrictive lung disease;  
o coronary artery disease (CAD);  
o congestive heart failure (CHF);  
o peripheral vascular disease (PVD);  
o severe liver disease (e.g. cirrhosis);  
o diabetes with end-organ damage;  
o renal failure; and  
o dementia.  
o We will also include patients who are ventilator-dependent (receiving long-term mechanical 
ventilation) and have been admitted from a long-term acute care (LTAC) facility.  
• Acute illness criteria include APACHE II (alternately SOFA or trauma severity) score predicting a 15% or 
greater risk of hospital mortality.   
• Acute illnesses and conditions include:   
o acute respiratory distress syndrome (ARDS) with P/F ratio <=300;  
o on extracorporeal life support (ECLS or ECMO);  
o cardiopulmonary arrest, with Glasgow coma score <12;  
o subarachnoid hemorrhage (SAH) Fisher grade 3/4 with Glasgow coma score <12;  
o spontaneous hemorrhage (ICH, IPH, EDH, SDH) with Glasgow coma score <12;  
o stroke or cardiovascular accident (CVA) with Glasgow coma score <12;  
o decompressive/crash craniotomy (bone flap) with Glasgow coma score <12;  
o traumatic brain injury (TBI) or diffuse axonal injury (DAI) based on MRI ~day 10; or  
o anoxic brain injury due to cardiac arrest >48 hours;  
o or acute respiratory failure requiring invasive mechanical ventilation.  
o We will also include patients with:  new spinal cord injury causing quadriplegia, and confirmed 
COVID-19 who are admitted to the ICU. 
• If patients do not have decisional capacity and have no legal surrogate decision-maker to provide 
consent, they will not be eligible for participation. 
 
--FAMILY-- 
Eligible family subjects will be those who are 18 years of age or older, English-speaking, and identified by 
the patients as someone they would want involved in his or her medical care or decision-making.   
• Eligible family may include any of the following:  legal guardians, durable power of attorney for 
healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends. 
“Family” is not confined to legal next-of-kin or immediate family members.   
• If the patient does not have decisional capacity at the time of enrollment, family subjects will be 
identified by the patient’s legal surrogate decision-maker or legal next of kin, which in Washington State 
is determined by a hierarchical list of the following:  legal guardian, durable power of attorney for 
healthcare, spouse or legal domestic partner, adult children, parents, and adult siblings, and extended 
family (e.g. adult grandchildren, aunts/uncles) and close friends who are familiar with patient.   
• There is no limit on the number of family members allowed to participate. 
 
--CLINICIAN AND ADMINISTRATOR POST-STUDY INTERVIEW SUBJECTS--  
Eligible clinicians and administrators will be those who are 18 years of age or older, English-speaking, 
employed at a participating hospital and who we believe have a familiarity with the study and the 
intervention based on study enrollment and tracking data. 

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5.2 
EXCLUSION CRITERIA 
 
--PATIENTS--  
We will exclude patients: with an anticipated ICU stay of less than 2 days/48 hours, as assessed by the 
critical care attending physician or his/her designee; those admitted for suicide attempt; or those 
withdrawal of life support (WDLS) pending. Reasons for exclusion for a patient also include:  legal or risk 
management concerns (as determined by the attending physician or via hospital record designation); 
psychological illness or morbidity; physical or mental limitations preventing ability to complete 
questionnaires; and prior refusal or enrollment to this study (e.g. for patient that has been readmitted to 
ICU during the study period). We will also exclude patients who have been in the ICU for >14 days. During 
access and visitation restrictions due to COVID-19, we will be excluding patients with clearly documented 
decisional-capacity who meet eligibility requirements but cannot be contacted and recruited/consented 
for the study.  
 
--FAMILY-- 
Reasons to exclude family member subjects include:  legal or risk management concerns (as determined 
by the attending physician or via hospital record designation); psychological illness or morbidity; physical 
or mental limitations preventing ability to complete questionnaires; and prior refusal or enrollment to this 
study (e.g. family of a patient who has been readmitted to ICU during the study period).  
 
--CLINICIAN AND ADMINISTRATOR POST-STUDY INTERVIEW SUBJECTS--  N/A 
5.3 
LIFESTYLE CONSIDERATIONS 
 
N/A 
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Family member subjects who do 
not complete the baseline questionnaire will be “withdrawn”. If they decline to continue participation, 
we will note the ‘refusal reason’. If we are unable to contact them after that point, we will consider them 
to be ‘passive refusals.’  
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Strategies for Recruitment: We will recruit within the ICUs of three hospitals that compose UW Medicine 
in the Puget Sound region.  
 
As of March 2020, due to the COVID-19 pandemic, we are making modifications to apply to patients and 
family members affected by the outbreak --both directly (e.g. testing positive) and/or indirectly (e.g. social 
distancing/staying home) -- to limit contact between patients, family, and research staff members and to 
accommodate the limited visiting policies in place at UW Medicine hospitals.  There are two scenarios to 
which these changes apply: 1) Patients with COVID-19 disease or on COVID-19 rule-out status. In this 

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scenario, all contact with family (or patient) will be by phone or Zoom; and 2) Patients with non-COVID-
19 status (after ruling out or not tested). In this scenario during the COVID-19 Adaptation implementation, 
most contact will be by phone or UW Zoom, although in person contact is acceptable if family are 
interested, family have no symptoms, and staff are able, willing, and without any symptoms of COVID-19. 
 
 --PATIENTS-- 
Study staff will identify consecutive patients in the ICU by screening the prior 12 months or longer of the 
patient’s medical records to determine potential eligibility of patient subjects.  In order to conduct the 
screenings, the research team will obtain:  1) a waiver of consent; 2) a waiver of HIPAA authorization; and 
3) all necessary institutional confidentiality agreements. If a patient meets the entry criteria, study staff 
will then approach the primary physician caring for the patient to confirm the patient’s eligibility. The 
physician will also have an opportunity at this time to exclude a patient or family who, in the physician’s 
judgment, would not be an appropriate participant.  
 
For patients without capacity, study staff will ascertain who is the legal surrogate decision-maker (LNOK). 
This legal surrogate decision-maker will be identified using current Washington State law. If willing to 
participate, the legal surrogate will be asked to go through informed consent for the incapacitated patient. 
If there is more than one individual who is a legal surrogate decision-maker, we will obtain consent from 
all legal surrogate decision-makers who are interested in being involved in the consent process (i.e., adult 
children or siblings) although we will obtain written documentation of consent for the patient’s 
involvement from only one legal surrogate decision-maker.  The LNOK will also be consented in their own 
capacity as a participating family member, if willing to participate.  
 
Eligible patients will also be screened for limited English proficiency or cognitive impairment with a six-
item screening tool to assess cognitive impairment for participation in research. Study staff will contact 
the patient in person or by telephone or, if the patient does not have decisional capacity, a legal next of 
kin (LNOK) in person or by telephone.  A study staff member will provide an overview of the study via 
talking points, handouts, and/or an informational video, and ask if the patient/LNOK is willing to continue 
with recruitment and consent processes.  Enrollees will be provided with a packet of information that 
includes the study overview and checklist of activities, as well as copies of the signed consent documents.  
All conversations with potential subjects regarding the study will be held in a private setting or by 
telephone; study staff will allow for potential subject’s desire to have family present or to confer and make 
participation decisions in his or her own time. Decisional capacity will be determined by the attending 
physician (or designee) to align with clinical practice. If patients regain capacity, they will be asked to 
provide consent and HIPAA authorization.  Patients with neither capacity nor an available LNOK will be 
ineligible.  
 
In the event that the patient/LNOK cannot be recruited in person due to COVID-19 involvement, we will 
take the following steps: 
• 
Confirm that the LNOK is aware of the patient’s hospitalization and health status by reviewing 
Social Work notes from the time of admission.  
• 
Call the LNOK to initiate recruitment by telephone.  
• 
Provide consent and HIPAA forms for the LNOK by mail or email.  
• 
Waive written documentation of consent and HIPAA for interested participants; attempt to collect 
signed forms by mail whenever possible.  
 
Consent from the LNOK will be sufficient to allow the patient to be enrolled even if other family members 
do not choose to participate. For instance, after enrollment the LNOK may choose to meet with the 

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facilitator even though other family members have declined; however, if non-consenting family members 
choose to be in an activity with intervention components, those components may be discontinued, if 
requested by the family, to allow all family members to participate in the activity. If a family conference 
is scheduled and both consenting and non-consenting family members attend, the facilitator will offer to 
not attend the conference. If the legal surrogate decision-maker(s) would like to have other family 
members involved in the study, these other family members will be asked to consent for their own role 
as study participants as noted below. If the patient has a family member or friend that is not recognized 
as the legal surrogate decision-maker by state law, this person will also be included in the study as a 
participant provided the legal surrogate decision maker does not object (or, if there is more than one legal 
surrogate decision-maker, that none of them object).  
 
--FAMILY--   
Family members will be recruited in person, by telephone or UW HIPAA-compliant Zoom for the main 
study. A study staff member will provide an overview of the study via talking points, handouts, and/or an 
informational video, and ask if the family is willing to continue with recruitment and consent processes.  
Enrollees will be provided with a packet of information that includes the study overview and checklist of 
activities as well as copies of the signed consent documents. All conversations with the family members 
regarding the study will be held in a private setting by telephone or UW HIPAA-compliant Zoom. Only 
study staff will have access to the contact information provided by the family members for participation 
purposes. 
 
In the event that the family member cannot be recruited in person due to COVID-19 involvement, we will 
take the following steps: 
• 
Confirm that the family member is aware of the patient’s hospitalization and health status by 
reviewing Social Work notes from the time of admission.  
• 
Call the family member to initiate recruitment by telephone.  
• 
Provide a consent form for the family member by mail or email.  
• 
Waive written documentation of consent for interested participants.  
 
--PATIENTS and FAMILIES FOR POST-STUDY INTERVIEWS--  
For the recruitment for patient and family post-study interview, we will re-contact enrolled subjects as 
noted in their consent forms. We anticipate contacting participants by phone to arrange an interview date 
and time. We will mail or email supplemental information sheets specific to the interview with 
appointment reminders and thank you payments. If a participant would like to complete the interview at 
the time of this initial call, we will still provide them with the paper information sheet when we send the 
thank you payment.  
 
--CLINICIAN AND ADMINISTRATOR and INTERVENTIONIST POST-STUDY INTERVIEW SUBJECTS--  
Clinicians and administrators will be identified by the study team via purposive sampling and recruited by 
email, phone or in person. Contact information for clinicians and administrators is available through 
institutional directories. A study staff member will provide a scripted overview of the interview 
component including the purpose, procedures and expected time commitment.  
 
 
Anticipated Enrollment:  
Patient Subjects, n=376 

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Family Member Subjects, n=564 
 
 
Clinician & Administrator Interview Subjects, n=15 
 
 
Inclusion of Women and Minorities:  Based on our prior ICU-focused communication facilitator study, we 
estimate the proportion of women among patients in the proposed study will be approximately 40%; this 

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is slightly less than the proportion of women in King County (50%), but reflects the population of critically 
ill patients. We estimate the proportion of women among family subjects in the proposed study will be 
approximately 70%; this is slightly more than the proportion of women in King County, but reflects the 
population of the family and caregivers of critically ill patients. We anticipate that minority representation 
of the patient and family subjects will reflect the demographics in the areas under study, specifically the 
residents of King County Washington where the three participating hospitals are located. Clinician and 
Administrator subjects will be purposively sampled to ensure a diverse group based on race/ethnicity, 
age, and gender. 
 
Although we are using a population-based sampling strategy in which we are identifying all eligible ICU 
patients without over-sampling by gender or race/ethnicity, we will use accepted methods for enhancing 
recruitment and retention of minorities. These include: 1) use of culturally sensitive recruitment materials; 
2) incorporation of appropriate reading levels in all study materials; 3) attention to aspects of health 
literacy as it influences both the intervention and evaluation; 4) staff support for questionnaire 
completion; and 5) staff training in cultural sensitivity. These methods will also be used with family 
subjects; however, their association with enrolled patients will determine their identification. We will 
monitor patient recruitment and, if necessary, institute over-sampling to ensure minority representation. 
In addition, the School of Medicine has a Center for Equity, Diversity and Inclusion (CEDI) dedicated to 
workforce diversity, multicultural education, and community engagement and development [http://cedi-
web01.s.uw.edu]. CEDI provides training, tools, and resources, including support for designing 
recruitment materials and inclusive curricula, cultural proficiency training, and community engagement.  
The CEDI will serve as a resource for training, tools, and recruiting a diverse research staff and also as a 
resource for recruiting diverse research participants. Based on our previous studies, we do not expect 
differences due to minority status, but we are collecting sex/gender and race/ethnicity data and will 
include them as covariates in our multivariate analyses. 
 
Participants must have sufficient proficiency with the English language to be able to adequately 
participate in study activities including interacting with the communication facilitator both in-person and 
by telephone, and completing self-administered questionnaires. Although we would like to broaden our 
sample to include non-English speakers, the diversity of languages that are characteristic of our region 
makes it difficult to provide adequate coverage for this randomized trial.  For example, although 15% of 
the patient population at Harborview Medical Center is non-English speaking, no single non-English 
language predominates and at least eight different languages are common among this population. 
 
Proposed Engagement Strategies for Retention:  Study participants in the RCT will be engaged throughout 
the study period through regularly scheduled contacts with the facilitator (for intervention subjects) or 
study staff (for intervention and control subjects). Initial intervention activities will occur during the 
hospitalization for patients and families in the intervention arm; patients in the control arm will receive 
usual care without the assistance of the facilitator but will be offered the opportunity to speak to the 
research coordinator (as an additional resource) at regular intervals.  Intervention subjects will receive 
services from the facilitator for the 3-month period after randomization. Both intervention and control 
subjects will complete questionnaires at 1, 3, and 6 months after enrollment.  Qualitative interviews will 
occur by phone after patients and families have completed their final questionnaires. Study staff 
conducting recruitment will be encouraged to provide a clear explanation of how the study could help 
patients and families in the future; offer time for them to consider participation; and to have excellent 
communication skills, express empathy, and be knowledgeable about ICU, hospital and community 
resources.   
 

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Intervention Subjects. During the ICU stay, facilitators will have daily (Monday-Friday) interactions with 
patient and family subjects. Depending on need, facilitators may also be available at other times. 
Following the ICU stay, facilitators will interact with patients and family in person at patients’ homes 
and/or care facilities and by phone for three months from randomization or for one month after a patient 
death occurring in the first three months. Because prior studies suggest frequent contact is important, 
the schedule for contact will be a minimum of every 48 hours in the hospital, within 72 hours of change 
in care setting, weekly for a month after hospital discharge, and then twice monthly for the remainder of 
the 3-month period. The facilitators will use clinical judgment if they feel more frequent contact is 
warranted, and patients and families will have access to facilitators through phone and email 5 days per 
week. During the follow-up questionnaire period, study staff will contact each participant at each interval 
(1, 3 and 6 months) by phone. During those calls, study staff will administer the questionnaires or remind 
participants to complete questionnaires by mail or online. All questionnaires and other study materials 
will be created with an appropriate reading level, formatted for ease of use, and have contact information 
for the study staff or study office clearly visible.  
 
Control Subjects.  Patients and family members randomized to the control arm will complete the same 
study measures at all data collection points, but the facilitator will not be involved.  Instead, these patients 
will receive an attention control in which study staff will contact enrolled patients and family members 
regularly to answer questions, provide information about resources, track participants’ location and 
health status, as well as provide reminders about upcoming questionnaire mailings and the need to 
complete and return questionnaires. While participating patients are in the hospital and for the first 
month after enrollment, study staff will contact the patients/families on an as-needed basis; for the 
remaining five months, study staff will contact the patient/family at the times of the follow-up 
questionnaires (3 and 6 months).  During these calls, study staff will administer the questionnaires or 
remind participants to complete questionnaires by mail or online. All questionnaires and consent 
materials will be created with an appropriate reading level, formatted for ease of use, and have contact 
information for the study staff or study office clearly visible.  
 
Family of patients who die during the study. For patients who die in the hospital or during the follow-up 
period, we will send a condolence card when we become aware of the patient’s death, and will delay 
sending any additional study materials until a month after the patient’s death.  
 
Participant Incentives:  
In order to encourage participation and acknowledge the time involved in questionnaire completion, we 
are providing $10 to each participant. These incentives are provided in advance of the completion of the 
questionnaires as it has been shown that it is at this time point, rather than after completion of 
questionnaires, that they are most effective. Interview subjects will receive $25 after the interview as an 
acknowledgement of their contribution to the study. ‘Thank you’ payments are kept small to minimize 
coercion or undue influence.  
 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
 
6.1 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
 

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6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
 
This study is a randomized trial of an intervention to improve outcomes for patients and their family by 
supporting, modeling, and teaching communication strategies that enable patients and their families to 
secure care in line with a patient’s goals over an illness trajectory, beginning in the ICU and continuing to 
care in the community.  
 
If patients with decisional capacity and family agree to participate, they will complete informed consent 
procedures and HIPAA authorization. If patients do not have decisional capacity but are eligible for the 
study, LNOK will complete informed consent procedures and HIPAA authorization.  Subjects assigned to 
the intervention arm will work with a communication facilitator and will complete assessments/measures; 
subjects assigned to the control arm will complete assessments/measures only. Family will be clustered 
under patients.  
 
A short study summary will be included in the patient’s electronic health record (EHR). This summary will 
be included for both the intervention and control patients.  
 
• 
Control Arm/Usual Care: Patients and family members randomized to the control arm will 
complete the same study measures at all data collection points, but the facilitator will not be involved.  
Instead, these subjects will be contacted prior to the follow-up questionnaires at 1-month, 3-months and 
6-months from randomization. During the calls for these subjects, they will be asked if they have any 
questions about study procedures and be reminded about upcoming surveys. The revised "Information & 
Resources Provision Arm/Comparator" study arm is an adaptation to the Facilitator Protocol for use 
during the COVID-19 pandemic. For those randomized to “Control/Usual Care,” participation in this 
comparator arm will be available at the participant’s request. The goal of this comparison group is to offer 
family members a contact person for questions related to their loved one’s care. The resource person 
(trained study staff or research RN) will contact family members within 1-2 days of enrollment and 
randomization.  They will introduce themselves as a resource for finding or providing information in this 
stressful and difficult time.  All contact will be by telephone or UW HIPAA-compliant Zoom on the following 
schedule: 
 
a. Within 1-2 days of randomization 
 
b. Within 1-2 days of transfer to acute care. 
 
c. Within 1-2 days of hospital discharge. 
The resource person is intended to provide information and help families connect with the right person 
at the hospital or on the patient's healthcare team to provide help and support. 
 
• 
Intervention Administration: Intervention activities will be conducted with intervention subjects 
only. Beginning during the ICU stay, and continuing for three months, facilitators will interact in person, 
by telephone, or UW HIPAA-compliant Zoom with patients and family subjects, and those clinicians 
(physicians, nurses, social workers, spiritual care, etc.) involved with patients’ care.   
 
After baseline data collection, the facilitator will begin providing the intervention to patients in the ICU 
and their families. The intervention will include communication activities such as: discussion of values, 
provision of educational and informational materials as needed, and support and mediation if conflicts 
arise among the family or between family and the clinical team. The facilitators will provide these activities 
in a manner consistent with the subjects’ preferred attachment styles that are assessed at baseline.  
 

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During the patient’s hospitalization, the facilitators may enter notes in the electronic health record (EHR) 
to relay information in the patient’s chart that is relevant to communication between patient/family and 
the clinical team, for example:  "The patient's daughter expressed questions about rehab;" or “The 
patient's son may be reluctant to ask questions, informing him about what to expect next may be helpful."  
The facilitators also enter a Research Intervention Introductory note into the patient EHR so inform the 
clinical staff about their role with the patient/family. These notes will appear under “Chart 
Review/Notes/Type: Research Note” in the EHR system. Additionally, we will have signage in the hospital 
room noting that study facilitators are available for the patient enrolled in the intervention. The sign will 
mirror the note in the EHR. 
 
After the ICU stay, the facilitator will guide the patient and family through transitions to the acute care 
floor, discharge to home/rehabilitation or skilled nursing facility (SNF). Outside the hospital in the 
community, the facilitator will be available to make visits to a SNF or rehabilitation unit and/or the 
patient’s home and participate in outpatient clinic visits. The primary mission of the facilitator at these 
transitional contacts will be to support, model, and teach the communication skills that advance self-
efficacy, outcome expectations, and behavioral capacity for goals-of-care discussions that will advance 
care in line with those goals and across transitions.  
 
6.1.2 ADMINISTRATION AND/OR DOSING 
 
During the ICU stay, facilitators will interact in person with patients, family, and many types of clinicians 
(physicians, nurses, social workers, etc.). Following the ICU stay, facilitators will interact with patients, 
family and clinicians in person and by phone for 3 months from randomization (when most first 
readmissions occur) or for 1 month after a patient death occurring in the first 3 months. In-person contacts 
may include visits to patients’ homes and/or care facilities; phone contacts will include calls to patients, 
families and clinicians. Because prior studies suggest frequent contact is important,9-14 the schedule for 
contact will be a minimum of every 48 hours in the hospital, within 72 hours of change in care setting, 
weekly for a month after hospital discharge, and then twice monthly for the 3 months. The facilitators will 
use clinical judgment if they feel more frequent contact is warranted, and patients and families will have 
access to facilitators through phone and email 5 days per week. Facilitators will be available to attend 
clinic visits with patients. In addition to checking directly with patients/families during regular contacts 
(calls, visits), facilitators will also access the EHR to ensure they have accurate information about 
appointments and treatment plans and will document their interactions and key points for the clinical 
team.  
 
We strive to have the same facilitator work with the patient and family throughout the study. Facilitators 
will encourage referral to inpatient or outpatient palliative care services when palliative care needs (i.e., 
communication, decision-making, and symptom needs) are identified. Based on prior studies, sample size, 
and time projections, we estimate facilitators can have a caseload of 20 patients/facilitator/month, 
accounting for 1.6 FTE.15,16 This estimate is based on the following: 1) 4-5 new patients/month per 
facilitator; 2) an average of 12-15 visits/patient (i.e., 4-5 during the ICU stay, 4-5 during the first month 
following the ICU, and 4-5 during the remaining study period; 3) an average of 20-30 minutes per visit; 
and 4) 1 hour of preparation per visit. We will attempt to document facilitator contacts for each patient 
and family to assess intervention fidelity, “dose,” and costs. 
6.2 
FIDELITY 

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6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
 
• 
Training of facilitators: Training will be provided by all investigators and consultants with specific 
roles in: facilitator communication skills, decision support, the use of attachment theory, and mediation. 
Training will address the use of these skills across care settings (e.g., inpatient, outpatient, home, care 
facility). Communication training will include identification of goals of care, incorporating principles of 
advance care planning and the facilitated values history. Training in the decision support will address the 
use of goals to support decision-making. Attachment theory training will include understanding the four 
attachment styles, the consequences of these styles for communication, and the approaches most 
appropriate for each style. Mediation training will cover skills associated with assessment and 
preparation; mediator opening; presentation of the case, information gathering and exchange; 
development and evaluation of options; and resolution. Facilitators will participate in role-playing 
exercises during a two-day training and they will be required to demonstrate mastery of intervention skills 
before starting and during fidelity checks. We have conducted similar training previously with good 
results. We will expand the training manual to enhance dissemination of the intervention to other 
institutions. 
 
• 
Intervention fidelity: To ensure scientific rigor, intervention fidelity will be assessed with methods 
outlined by the NIH Behavioral Treatment Fidelity Workgroup on consistency in dose, providers, delivery, 
receipt, and enactment of interventions.17-18 Facilitators will meet weekly with investigators to discuss the 
intervention subjects and ensure intervention fidelity overall and between facilitators. We will use an 
intervention checklist assessing completion of all components. If concerns arise regarding fidelity, 
the appropriate expert will be consulted. There will also be a formal fidelity check via audio-recording and 
review of 10% of encounters.  Refresher-training sessions will be conducted regularly. 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
The unit of randomization is the patient. The potential for contamination is minimized because the focus 
of the intervention is specific to the individual patient and family and tailored to their needs. 
Randomization will occur in variable-sized blocks stratified by site. Family will be clustered under patients.  
 
The intervention precludes blinding clinicians, patients, or family to treatment group. However, we will 
blind study staff involved in data collection to group assignment via surveys send and completed by mail 
and online. A number of the outcomes could theoretically allow the introduction of bias if patients or 
family in the intervention arm give different ratings for reasons other than the intervention (i.e., to please 
researchers). Therefore, we will not highlight the primary outcome during the consent process, and all 
participants will receive contact with study staff for completion of study materials which will help mitigate 
this potential source of bias.  
6.4 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
N/A 
 
6.5 
CONCOMITANT THERAPY 

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N/A 
 
6.5.1 RESCUE THERAPY 
 
N/A 
 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 
Subjects may be withdrawn from the study without their consent if they can no longer meet the study 
requirements (e.g. no longer able to complete questionnaires). For any withdrawal, investigator or subject 
initiated, we will retain all data that was previously collected and continue to collect chart abstraction 
data, unless the subject specifically requests that the data no longer be used and access to records is 
revoked. 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participation is voluntary and participants may withdraw from the study at any time for any reason.  
 
An investigator may discontinue a participant from the study for the following reasons: 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation, 
• 
Lost-to-follow up; unable to contact subject, 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up  
study data would not be possible. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded study tracking 
database. Subjects who sign the informed consent form and are randomized but do not receive the study 
intervention will be replaced in order to meet enrollment goals. Subjects who sign the informed consent 
form, and are randomized and receive the study intervention, and subsequently withdraw, or are 
discontinued from the study, will be replaced in order to meet enrollment goals. 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return any of the study questionnaires 
scheduled visits and study staff are unable to contact the participant after at least 3 attempts at each time 
point.  
 
The following actions must be taken if a participant fails to return a study questionnaire: 
• 
The RC will attempt to contact the participant, resend the survey packet or online link, and offer 
to complete the study instruments by phone. The RC will remind the participant that we value 
their responses and participation. 

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• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
 
Pre-Screening: automated lists of consecutive patients admit to participating ICU services are generated 
using ICD10 codes and calculated APACHE II scores to narrow assessment of eligibility; time frame is within 
48 hours of ICU admission; existing information from the patient’s EHR will be accessed, obtained and 
kept as study data under a waiver of HIPAA authorization. 
 
Screening: study staff manually screen patient electronic health records to confirm eligibility using 
established inclusion and exclusion criteria; time frame is 10-14 days from eligibility.   
 
Recruitment: study staff contact eligible patient, LNOKs, family members to inform them about the study 
and ascertain if they are interested and able to participate; time frame is 10-14 days from eligibility.  
 
Enrollment: subjects complete informed consent procedures with study staff and are given baseline 
questionnaires to complete (in person, by mail, by telephone, or online); time frame is 10-14 days from 
eligibility, however additional family members may be enrolled after this period until 1-month from 
patient randomization.  
 
Randomization: subjects are randomized when a family member’s completed baseline questionnaire has 
been received by the study; time frame is within 1 business day from receipt.  
 
Intervention: a communication facilitator (study nurse/interventionist) makes contact with the enrolled 
subject within 1 business day from randomization; duration of intervention is 3 months, however this may 
be shorter if the patient dies, or extended if the facilitator finds a need to do so based on her clinical 
judgement; facilitators have a final contact with participants at the end of the period.  
 
Control: subjects are contacted by study staff as the patient’s hospital trajectory is monitored; time frame 
for check-in contacts is at transition out of ICU/to acute care, discharge from hospital, and in the event of 
patient death (condolence card).  
 
Follow-up at 1-month: subjects are contacted by study staff and reminded of the first follow-up 
questionnaire at 1 month after randomization; reminders are sent at two weeks if questionaries have not 
been returned; subjects may also be reminded by phone, email, text for six weeks (one contact per week).  
 
Follow-up at 3-months: subjects are contacted by study staff and reminded of the second follow-up 
questionnaire at 1 month after randomization; reminders are sent at two weeks if questionaries have not 
been returned; subjects may also be reminded by phone, email, text for eight weeks (one contact per 
week).  
 
Follow-up at 6-months: subjects are contacted by study staff and reminded of the third follow-up 
questionnaire at 1 month after randomization; reminders are sent at two weeks if questionaries have not 

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been returned; subjects may also be reminded by phone, email, text for eight weeks (one contact per 
week) and a second reminder questionnaire is sent at the end of the eight weeks.  
 
Interview: purposively sampled participants will be contacted by study staff to ascertain their availability 
and interest in participating in a qualitative interview at the end of their study period.  
 
Chart abstraction: additional data will be collected from the patient’s EHR at the end of the study period 
to evaluate the intervention; existing information from the patient’s EHR will be accessed, obtained and 
kept as study data with HIPAA authorization from patient or the patient’s LNOK/LAR. 
8.2 
SAFETY ASSESSMENTS 
 
N/A 
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered intervention 
related. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
 
The UW IRB definition of Serious Adverse Events is: Any untoward or unfavorable medical occurrence in 
a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory 
finding), system, or disease temporally associated with the subject’s participation in the research. The 
research may or may not be causally related to it.  
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 
For adverse events (AEs), the following guidelines will be used to describe severity.  
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
 

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All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by appropriately trained clinicians based on temporal relationship and their clinical judgment. 
The degree of certainty about causality will be graded using the categories below.  
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study procedures administration and cannot be 
explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study procedures should be clinically plausible. The event must be pharmacologically or 
phenomenologically definitive. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a 
reasonable time after administration of the study procedures, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal.  
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study procedures administration makes a causal relationship improbable 
(e.g., the event did not occur within a reasonable time after administration of the study 
procedures) and in which other drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study procedures administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
8.3.3.3 EXPECTEDNESS  
 
A clinician with appropriate expertise in clinician care will be responsible for determining whether an 
adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, severity, 
or frequency of the event is not consistent with the risk information previously described for the study 
procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits, data collection, reminders or check-in contacts, and/or interviews of 
a study participant, or upon review by a study monitor. 
 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate report form. 
Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study procedures (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will be 
documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 

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Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. Documentation of onset and duration of each episode will be 
maintained for AEs characterized as intermittent. 
 
Research coordinators will record events with start dates occurring any time after informed consent is 
obtained until 30 days after the last day of study participation.   
8.3.5 ADVERSE EVENT REPORTING  
 
Adverse Events are reported to the UW IRB within 10 business days. Adverse Events are also reported to 
the Chair of the DSMC, who will make the decision whether to engage the full committee.  
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a Serious Adverse Event and shall report the results of such evaluation to the NIH, DSMC, 
and the reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 
working days after the investigator first learns of the event. 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
 
N/A 
8.3.8 EVENTS OF SPECIAL INTEREST  
 
N/A 
8.3.9 REPORTING OF PREGNANCY  
 
N/A 
8.4 
UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human Research 
Protections (OHRP).  OHRP considers unanticipated problems involving risks to participants or others to 
include, in general, any incident, experience, or outcome that meets all of the following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 

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• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
Corrective actions will be taken as needed and advised.  
8.4.2  UNANTICIPATED PROBLEMS REPORTING  
 
The investigator will report Unanticipated Problems (UPs) to the reviewing Institutional Review Board 
(IRB), and the Chair of the DSMC. The Unanticipated Problems report will include the following 
information: 
• 
Protocol identifying information: PI’s name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an Unanticipated Problem 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the Unanticipated Problem 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
• 
Unanticipated Problems that are serious adverse events (SAEs) will be reported to the IRB, the 
DSMC, and to the funding agency within 10 working days of the investigator becoming aware of 
the event  
• 
Any other Unanticipated Problems will be reported to the IRB and to the DSMC within 10 working 
days of the investigator becoming aware of the problem  
• 
All Unanticipated Problems should be reported to appropriate institutional officials in accordance 
with the IRB’s receipt of the report of the problem from the investigator and determination of 
subsequent action.  
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESES 
 
• 
Specific Aim 1, Primary Endpoint 
Hypothesis: The intervention will improve patient and family outcomes, compared to attention 
control. 
 
• 
Specific Aim 2, Secondary Endpoint 
Hypothesis: The intervention will improve value by reducing ICU costs, hospital costs and 
readmissions and improve the cost-consequence ratio for each outcome as compared with 
attention control. 
 
• 
Specific Aim 3, Other Outcomes  

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Anticipated findings: We will identify primary factors associated with key implementation 
outcomes. 
 
9.2 
SAMPLE SIZE DETERMINATION 
 
The primary focus for sample size estimation is the primary outcome: mean family member depression 
over 6 months as assessed by the HADS depression subscale. For all calculations, we assume a two-sided 
test with a significance level of 0.05. If we assume 300 total family members (1 family member per patient 
and 150 per arm), a standard deviation of HADS depression scores of 4.2 points in both arms, 3 
measurements of depression (at 1,3, and 6 months), and an intraclass correlation (ICC) of 0.2, we will be 
able to detect a difference in mean depression of at least 0.93 points with 80% power and 1.07 points 
with 90% power (Power Table Below). These detectable differences at 80% power become 0.86 if the ICC 
is 0.1 and 1.05 if the ICC is as high as 0.4. If we had only 1 measurement instead of 3 per family member 
or, equivalently, if the ICC were 1, we would have 80% power to detect a difference of at least 1.36 points. 
Across all of these varying conditions, detectable differences are slightly within or below estimates of the 
minimally clinically important difference (MCID) of 1.6 to 2.0 available from the literature, suggesting we 
will have adequate power to identify a minimally clinically important difference.19-27 Although these MCIDs 
and minimum detectable effects are just estimates, they provide the best available evidence that power 
will be adequate to detect relatively small but important differences.  We anticipate >80% complete data 
for all outcomes so we will randomize 376 patients to achieve 300 patients and at least 300 family 
members with complete data. If our response rate is 70%, then we would expect responses for 263 
patients and at least 263 family members and with an ICC of 0.2, we would be able to detect a difference 
in mean depression of at least 0.99 points with 80% power. If we have more than 1 family member per 
patient (1.5 is expected), we will be able to detect smaller differences at the same power. In addition, we 
have 80-90% power to detect reasonable effects for other continuous outcomes in Aim 1. For the binary 
outcome of goal-concordance care, we have about 80% power to detect a difference in proportion 
concordant of 0.6 and 0.7, with 3 measurements from each of 300 total participants and an ICC of 0.13; 
the estimate of 0.6 for the controls is from a prior study and our preliminary data.28,29 We targeted power 
to identify differences within or slightly less than available estimates of “minimally important clinical 
differences” so that we would be confident that we would be powered to detect a minimally important 
clinical difference. 
 
Power Table: Range of minimum detectable effects with 80%- 90% power for HADS 
OUTCOME MEASURE 
Range of Minimum Detectable 
Effects* (†MCID if known) 
Standard deviation6 
HADS depression subscale 
0.86 – 1.3 (†1.6-2.0) 
4.2  
HADS anxiety subscale 
0.97 – 1.47 (†1.6-2.0) 
4.75  
HADS total score 
1.69 – 2.56 (†1.6-2.0) 
8.25  
*Range due to: intraclass correlation (0.1-0.4), response rate (70% or 80%), and power (80% or 90%); †MCID = estimates of 
minimal clinically important difference 
 
9.3 
POPULATIONS FOR ANALYSES 
 
• 
Specific Aim 1, Primary Endpoint 
Intention-to-Treat (ITT) Analysis Population: Randomized family members of critically ill patients  

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• 
Specific Aim 2, Secondary Endpoint 
ITT Analysis Population: Randomized patients experiencing hospitalization due to critical illness  
 
• 
Specific Aim 3, Other Outcomes  
Analysis Population: Participating family members and clinicians, administrators 
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
Our primary analysis approach involves mixed effects models. This likelihood-based approach assumes 
that missing data (responses) are missing at random. However, this assumption may not hold, so further 
sensitivity analysis is necessary.  Multiple imputation using MICE will be performed to address missing 
data. Missing values will be imputed based on patient characteristics (minority race, age and having three 
or more chronic diagnoses), family characteristics (age, education, employment, self-reported health 
status and financial situation) and outcomes from previous time points. Twenty imputations will be 
performed, and final results will be pooled. The multiple imputation approach will be useful for our 
sensitivity analyses which include adjustment for covariates, some of which may be missing for some 
participants.  
 
We will also perform sensitivity analyses regarding handling of missing data and enrollment characteristics 
of participants. We will consider different approaches and summarize any similarities and differences in 
results or conclusions from these approaches. 
 
Our goal will be to minimize missing data through minimizing respondent burden, offering multiple 
methods for survey completion, and having trained staff with repeated contact with participants. 
However, data could still be missing due to skipping individual items on a survey, omissions in EHR, lack 
of follow-up, or death.  We will quantify the amount of missing data, evaluate associations with participant 
characteristics, and minimize bias by applying appropriate methods to account for missing data. 
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
 
• 
Specific Aim 1, Primary Endpoint 
Our primary outcome is family member symptoms of depression over the 6-months post-randomization 
period. We will follow the intention-to-treat principle. Our primary analysis will use a linear mixed effects 
model with family member symptoms at all time points (1,3,6 months) as the response, main effects for 
intervention and time points, and a random effect to account for multiple measurements (time points) 
per family member. Given multiple family members per patient, we will also include a random effect for 
family. Time point is included as a factor variable to allow for nonlinear effects. We will also adjust for 
site, since randomization is stratified by site, and consider adjustment for response (symptoms of 
depression for primary outcome) at baseline (randomization). This model allows the average response to 
be different at 1, 3, and 6 months, but assumes the intervention has the same effect at each of these 
times. The secondary analysis allows the effect of intervention to be different across time by including an 
interaction between time and intervention. The advantage of using the data at all three time points and 

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a mixed model approach is that we can gain precision; it also allows for missing responses, assuming the 
responses are missing at random. We will use a similar approach for the other continuous family and 
patient outcomes, and a generalized linear mixed effects model for the binary outcome of goal-
concordant care. As a sensitivity analysis, we will consider models including only one family member per 
patient, chosen randomly. 
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
• 
Specific Aim 2, Secondary Endpoints  
This aim will include utilization and costs during the study period from the EHR and institutional metrics.  
Results will be reported as:  
o Hospital readmission: 30 days after discharge from the index hospitalization 
o Hospital free days: 1 month (30 days) after randomization, 3 months (91 days) after 
randomization, 6 months (183 days) after randomization 
o ICU free days; 1 month (30 days) after randomization, 3 months (91 days) after randomization, 6 
months (183 days) after randomization  
o Healthcare Costs: from randomization to discharge from index hospitalization, up to 6 months 
(183 days) 
o Healthcare Costs: from randomization to 30 days after randomization 
 
• 
Specific Aim 3, Other Outcomes  
We will perform a thematic analysis of transcribed interviews to explore feedback on the intervention and 
ways to improve the intervention delivery and implementation. Analyses will be guided by the 
Consolidated Framework for Implementation Research (CFIR) in exploration of factors effecting 
implementation and by Outcomes for Implementation Research in exploration of 
implementation outcomes. Qualitative data will be imported into analytic software, where investigators 
will perform iterative, inductive coding to identify recurrent themes, categories, and relationships among 
themes and categories. 
 
9.4.4 SAFETY ANALYSES 
 
N/A 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
See below. 
 
9.4.6 PLANNED INTERIM ANALYSES  
 
N/A 
9.4.7 SUB-GROUP ANALYSES 
 
N/A 

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9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
N/A 
9.4.9 EXPLORATORY ANALYSES 
 
As an exploratory analysis, we will examine specific a priori sub-groups for heterogeneity of treatment 
effects to see if the intervention has a differential impact on patients or family members with poorer 
health competence, higher level of palliative care needs, or higher HADS scores at enrollment to help 
determine whether future implementation of the intervention should target high-risk groups. We will also 
explore the impact of patient and family member gender, age, and race/ethnicity on treatment effects.  
These analyses will use the same analytic approach as outlined above, with inclusion of an interaction 
between the treatment indicator and the variable of interest (measure of self-efficacy or age, for example) 
which is measured at enrollment. 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT 
AND 
OTHER 
INFORMATIONAL 
DOCUMENTS 
PROVIDED 
TO 
PARTICIPANTS 
 
For this study we have a Waiver of Documentation of Consent where subjects are recruited and enrolled 
remotely. They will receive copies of a consent form or an information sheet with all elements of informed 
consent and contact information for key study personnel and for the Human Subjects Division. 
Participants enrolled in person (patient, LNOK, family members) may complete written documentation of 
informed consent prior to completing surveys and starting the study intervention.  
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
• PATIENTS and FAMILY. Subjects will be approached in person in the hospital/ICU by research study staff 
who will review the written consent form. The approach will likely take place in the patient’s hospital 
room, or other private area. If any potential subject would like time to review the consent form and 
consider participation on his/her own, or in consultation with another family member, the study staff will 
leave copies of the consent form and return to review, answer questions, and collect written consent at 
a later time (up to a day later). 
 
For COVID-19 Adaptation: Subjects will be approached by phone by research study staff who will review 
the consent form and send copies via mail or email. The study staff will permit time to review, answer 
questions, and attempt to collect written consent whenever possible. 
 
• PATIENT, FAMILY, and CLINICIAN/ADMINISTRATOR and INTERVENTIONIST POST-STUDY INTERVIEWS. 
Subjects will receive an information sheet by mail or email. Research study staff (RA/RC) will review the 

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form after receipt by telephone and answer any questions before proceeding to schedule or conduct the 
interview. 
 
Study staff will ask if subjects have any questions, if they understand the procedures as outlined in the 
consent. Patients will be assessed for decisional capacity as part of recruitment/enrollment in the ICU 
prior to participation. 
 
Patient and family may feel that they are obligated to participate in the study due to being under the care 
of the UW Medicine system. We routinely address any concerns of this nature by explaining that 
participation is voluntary and that whether or not patients or family participate will not adversely affect 
the care the patient receives during their hospitalization or in the future.  
 
Clinicians/Administrators/Interventionists may similarly feel that they are obligated to participate due to 
being or having been affiliated with the same health system. We also address any concerns of this nature 
by explaining that participation is voluntary and that whether or not they participate will not adversely 
affect their standing within the institution. 
Informed consent will be an ongoing process through the duration of the study. Subjects will have 
opportunities to ask questions and will be reminded that participation is voluntary at each step – 
interactions with staff/facilitators, receipt of questionnaires, invitations to interview(s). 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, investigator, funding agency, and regulatory 
authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Institutional Review Board (IRB), and sponsor/funding agency and 
will provide the reason(s) for the termination or suspension.  
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
• 
Factors that prohibit completion of study activities (e.g. lock-down due to pandemic) 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally identifiable 
information from the study will be released to any unauthorized third party without prior written approval 
of the sponsor/funding agency.  
 
All research activities will be conducted in as private a setting as possible. 
 

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The study monitor, other authorized representatives of the sponsor or funding agency, representatives of 
the Institutional Review Board (IRB), regulatory agencies or representatives from companies or 
organizations supplying the product, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records for the participants in this study. The 
study site will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor/funding agency 
requirements. 
 
Study participant research data, for purposes of statistical analysis and scientific reporting, will be stored 
on site. These data will not include the participant’s contact or identifying information. Rather, individual 
participants and their research data will be identified by a unique study identification number. The study 
data entry and study management systems used by research staff will be secured and password protected.  
 
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies.  It is NIH policy 
that the results and accomplishments of the activities that it funds should be made available to the public 
(see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to share data will 
include proper plans and safeguards for the protection of privacy, confidentiality, and security for data 
dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a 
specific study participant). Plans for archiving and long-term preservation of the data will be implemented, 
as appropriate.  
 
Certificate of Confidentiality. To further protect the privacy of study participants, the Secretary, Health 
and Human Services (HHS), has issued a Certificate of Confidentiality (CoC) to all researchers engaged in 
biomedical, behavioral, clinical or other human subjects research funded wholly or in part by the federal 
government.  Recipients of NIH funding for human subjects research are required to protect identifiable 
research 
information 
from 
forced 
disclosure 
per 
the 
terms 
of 
the 
NIH 
Policy 
(see 
https://humansubjects.nih.gov/coc/index). As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, 
recipients conducting NIH-supported research covered by this Policy are required to establish and 
maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that 
the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of 
award. It is the NIH policy that investigators and others who have access to research records will not 
disclose identifying information except when the participant consents or in certain instances when 
federal, state, or local law or regulation requires disclosure. Investigators will inform research participants 
of the protections and the limits to protections provided by a Certificate issued by this Policy in the 
consent documents per the IRB template language.  
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
N/A 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Co-Principal Investigator 
Chair: DSMC 
Ruth A. Engelberg, PhD 
Kathleen Puntillo RN, PhD 

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University of Washington  
University of California 
325 Ninth Avenue, MS# 359765 
Seattle, Washington 
90 Illinois Street, Box 0610 
San Francisco, California 
206-744-9523 
415- 476-692 
rengel@uw.edu 
email: Kathleen.Puntillo@ucsf.edu 
 
This study has oversight by the IRB of record and a Data and Safety Monitoring Committee (DSMC).  
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of a Data and Safety Monitoring Committee (DSMC) composed 
of individuals with the appropriate expertise, including: Physiological Nursing, Implementation Research, 
Palliative Care and Medical Ethics, Family and Preventive Medicine, Pulmonary Sciences and Critical Care 
Medicine, and Biostatistics. Members of the DSMC will be independent from the study conduct and free 
of conflict of interest. The DSMC will convene biannually to assess safety and efficacy data from the study. 
The DSMC will operate under the rules of an approved data and safety monitoring plan that will be written 
and reviewed at the organizational meeting of the DSMC. At this time, each data element that the DSMC 
would like to assess will be clearly defined.  
10.1.7 CLINICAL MONITORING 
 
N/A 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent --- Study staff will review both the documentation and the consenting process.  This 
review will evaluate compliance with GCP, accuracy, and completeness.  Feedback will be provided by the 
Study Coordinator to the study team to ensure proper consenting procedures are followed.  
 
Intervention Fidelity — Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described in 
Section 6.2.1, Interventionist Training and Tracking.  
 
Protocol Deviations – The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 

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Data collection will be the responsibility of the clinical trial staff under the supervision of the study 
coordinator and the site investigator. The investigator will be responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. All source documents should be completed 
in a neat, legible manner to ensure accurate interpretation of data.   
 
Screening and tracking data will be entered into a separate study database and maintained by the 
research team with oversight from the study coordinator.  
 
Outcomes data will be collected into an Access database from hardcopy questionnaires completed in 
person or returned by mail. Questionnaires completed online will be compiled by the REDCap databases.  
 
10.1.9.2 STUDY RECORDS RETENTION  
 
Study records will be retained according to the schedules required by the University of Washington 
[https://finance.uw.edu/recmgt/gs/research].  
 
10.1.10 
PROTOCOL DEVIATIONS   
 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions will be developed by the site and implemented promptly.  
 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation, or within 10 working days of 
the scheduled protocol-required activity. Protocol deviations will be sent to the reviewing Institutional 
Review Board (IRB) and the Chairperson of the DSMC for this study. The site investigators will be 
responsible for knowing and adhering to the reviewing IRB requirements and recommended actions by 
the DSMC.   
10.1.11 
PUBLICATION AND DATA SHARING POLICY  
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed 
journals.  Data from this study may be requested from other researchers after the completion of the 
primary endpoint by contacting the Principal Investigators.  Considerations for ensuring confidentiality of 
these shared data are described in Section 10.1.3. 

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10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical. Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation in the 
design and conduct of this trial. The study leadership in conjunction with the NINR has established policies 
and procedures for all study group members to disclose all conflicts of interest and will establish a 
mechanism for the management of all reported dualities of interest. 
10.2 ADDITIONAL CONSIDERATIONS 
 
N/A 
 
10.3 ABBREVIATIONS AND SPECIAL TERMS 
 
AE 
adverse events  
AHRQ  
Agency for Healthcare Research and Quality  
ARDS 
acute respiratory distress syndrome  
CAD 
coronary artery disease  
CEDI 
Center for Equity, Diversity and Inclusion  
CFIR  
Consolidated Framework for Implementation Research  
CFR 
Code of Federal Regulations  
CHF 
congestive heart failure  
CoC 
Certificate of Confidentiality  
COPD  
Chronic obstructive pulmonary disease 
COVID-19  
Coronavirus disease 2019  
CPR 
cardiopulmonary resuscitation 
CVA 
cardiovascular accident  
DAI 
diffuse axonal injury  
DSMC  
Data and Safety Monitoring Committee 
ECLS  
extracorporeal life support  
ECMO 
Extracorporeal membrane oxygenation 
EDH 
epidural hematoma 
EHR 
electronic health record 
GCP 
good clinical practices 
GCS  
Glasgow Coma Score 
HADS 
Hospital Anxiety and Depression Scale  
HIPAA  
Health Insurance Portability and Accountability Act 
ICC 
intraclass correlation  
ICD-10 
International Classification of Diseases, version 10 

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ICH 
intracerebral hemorrhage 
ICH GCP 
International Council on Harmonisation Good Clinical Practice  
ICU 
intensive care unit 
IES-6 
Impact of Event Scale-6  
IPH 
Intraparenchymal hemorrhage  
IRB  
institutional review board 
ITT 
Intention-to-Treat  
LAR 
legally authorized representative 
LNOK 
legal next of kin 
LTAC 
long-term acute care  
MCID 
minimally clinically important difference  
MICE  
Multiple Imputation by Chained Equations  
MRI  
Magnetic resonance imaging 
N/A 
not applicable 
NCT 
National Clinical Trial  
NIH  
National Institutes of Health 
NINR 
National Institute of Nursing Research 
OHRP 
Office for Human Research Protections 
PCS 
Perceived Competence Scale 
PTSD  
Post-traumatic stress disorder 
PVD 
peripheral vascular disease  
QC 
Quality control  
QUAL-E (Fam) 
quality of life at the end of life (Family Version) 
RA 
research assistant 
RC  
research coordinator 
RSQ 
Relationship Style Questionnaire 
SAE 
serious adverse events  
SAH 
subarachnoid hemorrhage  
SDH 
subdural hematoma 
SES 
socio-economic status 
SNF 
skilled nursing facility  
SOFA  
sequential organ failure assessment 
SUPPORT  
Study to Understand Prognoses and Preferences for Outcomes and Risks of 
Treatments  
TBI 
traumatic brain injury  
UP 
Unanticipated Problems  
UW 
University of Washington  
UWMC 
University of Washington Medicine Centers 
WDLS 
withdrawal of life support  
 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
1.1 
10/24/18 
Clarification on recruitment and 
contact procedures requested by 
IRB 
Clarifying recruitment and 
contact procedures 
1.2 
3/11/19 
Screening changes; and 
Instrument changes 
Defining additional chronic 
and acute illness criteria and 
conditions for inclusion; and 
Refining data collection 
instruments 
1.3 
4/19/19 
Additional study aims addressing 
financial stress; and increasing 
sample size of clinician interviews 
Coordination with Financial 
Health and Wellness Study  
1.4 
7/3/19 
Revisions to recruitment protocol 
Revisions for assessing 
cognitively impaired subjects 
for inclusion 
1.5 
7/25/19 
Added chart note template; and 
Instrument changes 
Chart note documentation to 
alert clinicians to facilitators 
involvement; and refining 
data collection instruments 
1.6 
8/26/19 
Changes to interview guides 
Adding questions about 
financial stress 
1.7 
10/3/19 
Change to eligibility criteria; 
recruitment materials; DSMC; 
and Instrument changes 
Clarifying chronic illness 
conditions; change in state 
law regarding LNOK; timing 
of after-death surveys; 
change in DSMC chairperson; 
and refining data collection 
instruments 
2.10 
2/3/20 
Adding audio recording for 
fidelity assessment 
Adding audio recording for 
fidelity assessment 
2.11 
3/30/20 
Adding a new aim to explore the 
impact of COVID-19; adding 
eligibility criteria; revisions to 
recruitment protocol; adding 
contacts with research 
coordinator (RC) in usual care 
arm 
Adjustments in order to 
continue while hospital 
visitation and contact 
restrictions are in place; 
having RC as a resource to 
provide help and support for 
family members impacted by 
COVID-19 pandemic 
2.12 
6/10/20 
Updating Interview Guide 
Including questions 
specifically for control/usual 
care subjects, and to add 

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items pertinent to change in 
procedures due to COVID-19 
2.13 
8/25/20 
Screening changes; and Inclusion 
criterion 
Coordinating with other 
ongoing studies  
3.15 
2/14/21 
Updating eligibility criteria; 
updating contact schedule 
Broadening acute criteria; 
adding additional reminders 
in order to increase response 
rates 
4.17 
8/25/21 
Dropping patient questionnaires  
Have had only one patient 
well enough to complete a 
baseline questionnaire in the 
ICU. Lacking baseline 
questionnaires, we have not 
collected follow-up 
questionnaires from 
patients.  
4.19 
2/22/22 
Study information poster for 
patient hospital room 
Letting attending clinical 
team know that study 
facilitators are available for 
patient 
4.21 
5/23/22 
Increasing sample size of 
administrator interviews 
Broaden scope of 
respondents 
5.22 
12/21/22 
Increasing anticipated number of 
enrolled family members  
Continuing to recruit new 
subjects into no-cost 
extension  
5.23 
2/6/23 
Updating PI in all protocol and 
documentation  
Change in principal 
investigators 
6.0 
6/7/24 
Extending NIH certificate of 
confidentiality 
Extension to allow additional 
data collection if required  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES  
1. Rennke S, Nguyen OK, Shoeb MH, Magan Y, Wachter RM, Ranji SR. Hospital-initiated 
transitional care interventions as a patient safety strategy: a systematic review. Ann Intern 
Med 2013;158:433-40.  
2. Dy SM, Aslakson R, Wilson RF, et al. Improving Health Care and Palliative Care for Advanced 
and Serious Illness. Closing the Quality Gap: Revisiting the State of the Science. Rockville, MD: 
Agency for Healthcare Research and Quality; 2012 
3. Dy SM, Apostol C, Martinez KA, Aslakson RA. Continuity, coordination, and transitions of care 
for patients with serious and advanced illness: a systematic review of interventions. J Palliat 
Med 2013;16:436-45.  
4. Martinez KA, Aslakson RA, Wilson RF, et al. A systematic review of health care interventions 
for pain in patients with advanced cancer. Am J Hosp Palliat Care 2013.  
5. Fawole OA, Dy SM, Wilson RF, et al. A systematic review of communication quality 
improvement interventions for patients with advanced and serious illness. J Gen Intern Med 
2013;28:570-7. 3599019  
6. Carson SS, Cox CE, Wallenstein S, et al. Effect of Palliative Care-Led Meetings for Families of 
Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA 2016;316:51-62.  
7. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-
small-cell lung cancer. N Engl J Med 2010;363:733-42.  
8. Kentish-Barnes N, Chevret S, Champigneulle B, et al. Effect of a condolence letter on grief 
symptoms among relatives of patients who died in the ICU: a randomized clinical trial. 
Intensive Care Med 2017;43:473-84.  
9. Naylor MD, Aiken LH, Kurtzman ET, Olds DM, Hirschman KB. The care span: The importance of 
transitional care in achieving health reform. Health Affairs 2011;30:746-54.  
10. Feltner C, Jones CD, Cene CW, et al. Transitional care interventions to prevent readmissions 
for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med 2014.  
11. Brown RS, Peikes D, Peterson G, Schore J, Razafindrakoto CM. Six features of Medicare 
coordinated care demonstration programs that cut hospital admissions of high-risk patients. 
Health Affairs 2012;31:1156-66.  
12. Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of 
care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA 
2009;301:603-18.  
13. Naylor MD, Bowles KH, McCauley KM, et al. High-value transitional care: translation of 
research into practice. J Eval Clin Pract 2013;19:727-33.  
14. Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care 
of older adults hospitalized with heart failure: a randomized, controlled trial. Journal of the 
American Geriatrics Society 2004;52:675-84.  
15. Katon WJ, Von Korff M, Lin EH, et al. The Pathways Study: a randomized trial of collaborative 
care in patients with diabetes and depression. Archives of General Psychiatry 2004;61:1042-
9.  
16. Unutzer J, Katon W, Callahan CM, et al. Collaborative care management of late-life depression 
in the primary care setting: a randomized controlled trial. JAMA 2002;288:2836-45.  
17. Bellg AJ, Borrelli B, Resnick B, et al. Enhancing treatment fidelity in health behavior change 
studies: best practices and recommendations from the NIH Behavior Change Consortium. 
Health Psychol 2004;23:443-51.  

Facilitating Communication Study (FCS2) 
 
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Protocol UW STUDY00005369 
 
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18. Robb SL, Burns DS, Docherty SL, Haase JE. Ensuring treatment fidelity in a multi-site 
behavioral intervention study: implementing NIH Behavior Change Consortium 
recommendations in the SMART trial. Psychooncology 2011;20:1193-201.  
19. Puhan MA, Frey M, Buchi S, Schunemann HJ. The minimal important difference of the hospital 
anxiety and depression scale in patients with chronic obstructive pulmonary disease. Health 
Qual Life Outcomes 2008;6:46. 
20. Smid DE, Franssen FM, Houben-Wilke S, et al. Responsiveness and MCID Estimates for CAT, 
CCQ, and HADS in Patients With COPD Undergoing Pulmonary Rehabilitation: A Prospective 
Analysis. J Am Med Dir Assoc 2017;18:53-8.  
21. Stefanovics EA, Rosenheck RA, Jones KM, Huang G, Krystal JH. Minimal Clinically Important 
Differences (MCID) in Assessing Outcomes of Post-Traumatic Stress Disorder. Psychiatr Q. 
2018 Mar;89(1):141-155. doi: 10.1007/s11126-017-9522-y.  
22. Diaz-Arribas MJ, Fernandez-Serrano M, Royuela A, et al. Minimal clinically important 
difference in quality of life for patients with low back pain. spine (Phila Pa 1976) 
2017;42:1908-16. 
23. Parker SL, Adogwa O, Mendenhall SK, et al. Determination of minimum clinically important 
difference (MCID) in pain, disability, and quality of life after revision fusion for symptomatic 
pseudoarthrosis. Spine J 2012;12:1122-8.  
24. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal 
clinically important difference. Controlled Clinical Trials 1989;10:407-15.  
25. Luo N, Johnson J, Coons SJ. Using instrument-defined health state transitions to estimate 
minimally important differences for four preference-based health-related quality of life 
instruments. Medical Care 2010;48:365-71.  
26. Redelmeier DA, Guyatt GH, Goldstein RS. Assessing the minimal important difference in 
symptoms: a comparison of two techniques. Journal of Clinical Epidemiology 1996;49:1215-9.  
27. van der Roer N, Ostelo RW, Bekkering GE, van Tulder MW, de Vet HC. Minimal clinically 
important change for pain intensity, functional status, and general health status in patients 
with nonspecific low back pain. Spine 2006;31:578-82.  
28. Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical care inconsistent with 
patients' treatment goals: association with 1-year Medicare resource use and survival. J Am 
Geriatr Soc 2002;50:496-500.  
29. Fakhri S, Engelberg RA, Downey L, et al. Factors affecting patients' preferences for and actual 
discussions about end-of-life care. J Pain Symptom Manage 2016;52:386-94.