Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy Via Innovative Designs
Phase: NA
Conditions: Sudden Cardiac Death, Heart Failure
Sponsor: Duke University

 
 
Version February 27, 2020 
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VIVID 
Educational Videos to Address Racial 
Disparities in Implantable Cardioverter 
Defibrillator Therapy Via Innovative 
Designs 
 
 
 
STUDY PROTOCOL 
VERSION DATE: FEBRUARY 27, 2020 
PCORI GRANT NUMBER: AD – 1503 – 29746 
NCT02819973 
This document contains information that is privileged or confidential and may not be 
disclosed unless such disclosure is required by applicable laws and regulations.  

 
 
Version February 27, 2020 
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Table of Contents 
Project Leadership .......................................................................................................... 4 
Investigator Agreement ................................................................................................... 5 
BACKGROUND .............................................................................................................. 6 
SIGNIFICANCE .............................................................................................................. 7 
OBJECTIVES.................................................................................................................. 8 
METHODS ...................................................................................................................... 8 
ELIGIBILITY AND CONSENT ........................................................................... 8 
SCREENING, ENROLLMENT, AND CONSENT PROCESS ............................ 9 
BASELINE VISIT DATA .................................................................................... 9 
RANDOMIZATION AND BLINDING ................................................................ 10 
DATA SUBMISSION AND SITE TRAINING .................................................... 10 
POST-INTERVENTION VISIT ACTIVITIES .................................................... 11 
IN-DEPTH INTERVIEWS ................................................................................ 11 
RECRUITMENT .............................................................................................. 11 
INTERVENTIONS ......................................................................................................... 13 
BLACK INDIVIDUAL FOCUSED ICD EDUCATIONAL VIDEO ....................... 13 
WHITE INDIVIDUAL FOCUSED ICD EDUCATIONAL VIDEO........................ 13 
USUAL CARE ................................................................................................. 14 
STUDY INSTRUMENTS ............................................................................................... 14 
KNOWLEDGE QUESTIONNAIRE .................................................................. 14 
DECISIONAL CONFLICT SCALE ................................................................... 14 
IN-DEPTH INTERVIEW GUIDE ...................................................................... 14 
STATISTICAL ANALYSIS ............................................................................................. 15 
SAMPLE SIZE AND POWER CALCULATIONS ............................................. 15 
KNOWLEDGE QUESTIONNAIRE .................................................................. 16 
DECISIONAL CONFLICT SCALE ................................................................... 17 
ICD IMPLANTATION RATES .......................................................................... 17 
IN-DEPTH INTERVIEWS ANALYSIS .............................................................. 17 
CODING .......................................................................................................... 18 
QUALITATIVE ANALYSIS .............................................................................. 18 
ANTICIPATED SITE REGULATORY AND PERFORMANCE COMMITMENT ............. 18 
SITE COMMITMENT ....................................................................................... 18 
SITE REGULATORY AND PERFORMANCE REQUIREMENTS .................... 18 
ETHICAL AND REGULATORY CONSIDERATIONS ................................................... 19 
RISK/BENEFIT ASSESSMENT OF QUALITATIVE INTERVIEW ................... 19 
PRIVACY, DATA STORAGE, & CONFIDENTIALITY ..................................... 19 
ALTERNATIVES TO THE IPAD AND PROCEDURES ................................................. 20 
REFERENCES ............................................................................................................. 21 
APPENDIX A: KNOWLEDGE QUESTIONNAIRE......................................................... 23 
APPENDIX B: DECISIONAL CONFLICT SCALE ......................................................... 24 
APPENDIX C: VIVID QUALITATIVE INTERVIEW GUIDE ........................................... 26 
APPENDIX D: PROPOSED VIVID CALL CENTER SCRIPT ........................................ 26 
APPENDIX E: VIVID STUDY INFO SHEET ................................................................. 26 
 

 
 
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Figure 1: Study Processes .............................................................................................. 9 
Figure 2: Form and Content of Information Conveyed in 3 Study Arms ........................ 10 
Figure 3: Activities included in 1-Week and 90-Day Post-Intervention Follow-Up 
Interviews ...................................................................................................................... 11 
Figure 4: In-Depth Interview Design .............................................................................. 12 

 
 
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PROJECT LEADERSHIP 
 
Study Principal Investigator:  
 
Kevin L Thomas MD 
 
 
 
 
 
 
Assiociate Professor of Medicine 
Division of Clinical Cardiac Electrophysiology 
Duke Clinical Research Institute (DCRI) 
200 Morris St. 
Durham, NC 27701 
 
 
 
 
 
 
Email: kevin.thomas@duke.edu 
 
Study Funder:  
Patient Centered Outcomes Research Institute 
(PCORI) 
1828 L Street, NW, Suite 900 
Washington, DC 20036 
Phone: (202) 827-7700 | Fax: (202) 355-9558 
info@pcori.org 
 
 
Clinical and Data  
 
 
Laura Webb 
Coordinating Center:   
 
 
Project Leader 
Duke Clinical Research Institute 
200 Morris St. 
Durham, NC 27701 
Phone: (919) 668-8977 
Email: laura.webb@duke.edu 
 

 
 
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INVESTIGATOR AGREEMENT 
 
I have read the VIVID study protocol Version 27February2020, including all appendices 
and I agree that it contains all necessary details for my staff and I to conduct this 
protocol as described. I will personally oversee protocol conduct as outlined herein. 
 
I will provide all study personnel under my supervision with copies of the protocol and 
access to all information provided by PCORI or DCRI. I will discuss this material with 
personnel to ensure that they are fully informed about the conduct of the protocol and 
the information being collected from patients enrolled in the VIVID study. I am aware 
that, before commencement of this study at my clinical facility, the local (or central) 
institutional review board must approve this protocol. I agree to make all reasonable 
efforts to adhere to the VIVID study protocol. 
 
I, or my designee, agree to be present at all site visits and investigator meetings. In 
addition, I will ensure the presence of relevant study personnel under my supervision at 
these visits and meetings. 
 
I agree to provide all subjects with a signed copy of the informed consent form, as 
required by government and International Conference on Harmonization regulations. I 
further agree to report to the DCRI any protocol deviations in accordance with the terms 
of this protocol, Good Clinical Practice Guidelines, and applicable regulatory 
requirements. All information pertaining to the protocol shall be treated in a confidential 
manner. 
 
_________________________________ 
_____________________________ 
Principal Investigator Name (print) 
 
 
Signature 
 
_________________________________ 
 
Date 
 
 

 
 
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BACKGROUND 
 
Utilization of implantable cardioverter defibrillators (ICD) is lower in black indiviudals than 
white individuals after adjusting for health system related and socioeconomic variables. 1, 2  
Racial and ethnic disparity in ICD utilization is particularly disconcerting given the abundance of 
data on its efficacy in the primary and secondary prevention of sudden cardiac death (SCD) and 
the higher relative rates of SCD in black populations. Since its approval in 1985, the ICD has 
become the standard of care for patients with potentially lethal ventricular arrhythmias. 
Racial differences in patients’ willingness to accept a recommended invasive cardiac procedure 
may contribute to racial differences and potentially disparities in care. 3  Thus, patient education 
and reducing communication barriers between patients and physicians are important 
considerations in assisting patients with medical decisions. The quality of the doctor-patient 
interaction may influence both doctors’ recommendations and patients’ refusals, and it may be 
that communication is better when health care provider and patient race is concordant. 4 5 Race-
concordant physician visits are associated with higher levels of positive patient affect, greater 
length of time spent with the patient and reduced physician verbal dominance. 5, 6 Conversely, 
patients not of the same race as the physician receive less information, possibly because they 
are less likely to engage in communication behaviors, such as asking questions or expressing 
concerns that indicate desire for additional information. 7 Ultimately, willingness to accept a 
doctor’s recommendation may be influenced by the patient’s knowledge and familiarity with 
suggested treatment options and the effectiveness of the doctor-patient communication. 
The multiple and complex factors underlying racial disparities in cardiovascular procedures 
provide a range of levels for intervention: patient-level, physician-level and hospital systems-
level. Patient-level interventions that provide appropriate educational materials may encourage 
patients to participate actively in their health care and improve medical decision-making.  The 
format of educational materials affects patient knowledge and satisfaction with treatment.  In a 
randomized trial of an educational videotape versus ‘usual care,’ ischemic heart disease 
patients who viewed a videotape on their condition and treatment choices were significantly 
more knowledgeable about their disease state than those who received standard physician 
counseling. 8  
A key purpose of patient education is to increase patients’ confidence in making decisions that 
are congruent with their personal values. 9 One means of assessing whether a patient feels 
informed about treatment alternatives and their risks and benefits; has clarity about their 
personal values; and feels supported in choosing a course of action is the decision conflict 
scale.10  This tool has been used in numerous studies where patients face treatment decisions 
and are required to balance the known risks and benefits along with scientific uncertainty in 
choosing a course of action. One study, evaluated the effectiveness of educational videotapes 
for assisting newly diagnosed hypertensive patients (n=217) in the decision to start drug therapy 
for reducing blood pressure.11 The researchers found that patients who watched the videotape 
had a significantly lower decisional conflict (30.3 vs. 36.8, adjusted 95% CI = -7.4 to -0.6, P = 
0.021) and greater knowledge of their condition (75% vs. 65%, adjusted 95% CI = 6%- 13%, P < 
0.001) compared with corresponding controls.  
 
 
 
 

 
 
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SIGNIFICANCE 
 
Although it is clear that racial disparities in ICD therapy exist, no one has systematically studied 
reasons for these disparities or interventions to eliminate racial disparities in ICD implantation.  
Consequently, factors explaining this finding remain incompletely elucidated, but are likely 
similar to those seen in other cardiovascular procedures including influences at the patient, 
provider, and health system levels. In part, race-related patient preferences have been 
implicated.12-16  Members of certain racial groups may systematically prefer less intervention. 
Studies have shown that blacks are more likely to refuse an invasive cardiac procedure than 
whites.14, 15,17-19  Disparities that arise from patient preferences may be worthy of remediation. 
For example, it is important to consider reasons for a given preference of care and to distinguish 
between preferences that represent deeply held beliefs that are based on codified cultural or 
religious traditions from more transient beliefs that are based on unequal access to health care 
information or health myths. Although it is always useful to understand patient preferences, it is 
important to note that patient preferences should not be regarded as sacrosanct and that some 
preferences may be appropriately amenable to intervention and change.20  Recently, there has 
been a growing realization of the need to differentiate between patient preferences that are 
grounded in ethnicity or culture,(long-standing cultural traditions or deeply held and well-codified 
beliefs about health and medical treatment) from those grounded in modifiable perceptions or 
even misleading information (urban legends or myths that arise from unequal access to health 
care information). For example, Jehovah’s Witnesses may choose not to have curative surgery 
because they are unable to receive blood transfusions, due to their religious beliefs. By contrast, 
some black individuals choose not to have potentially curative lung cancer surgery because of 
the myth that the surgery and the concomitant exposure of the tumor to oxygen may cause the 
cancer to spread.21  Thus, understanding the root causes of patient preferences is important 
when determining the appropriateness of an intervention and when tailoring interventions that 
address underlying patient beliefs. Unfortunately, data suggest that patients are frequently 
misinformed or not fully informed when making health care decisions.22  Lack of understanding 
of a recommended procedure is a strong predictor of patient refusal, while clarity of information 
and hearing from others who have accepted similar recommendations are important in 
influencing decisions.22-24, 26, 27  At the provider level, racial disparities exist, partly, because of 
conscious or unconscious racial bias. In some instances, doctors do not offer or prescribe the 
same services for black patients that they do for white patients. 23, 28 Although most doctors 
strive to keep their clinical work free of bias, social psychology research documents that bias 
can occur without intention or recognition, and that certain situational factors, e.g., working 
under time pressure, can boost the effects of racial or gender stereotypes.23, 24   Studies have 
documented suboptimal communication between health care providers and ethnic minority 
patients. While the issues that limit provider/patient communication are not unique to racial and 
ethnic minority patients, they limit communication to the greatest degree among such individuals 
and therefore contribute to racial and ethnic disparities in care.25  In fact, some individuals prefer 
providers of the same racial or ethnic background. Racial concordance among black health care 
providers and patients appears to be a strong predictor of patients’ satisfaction with care, trust, 
and intent to follow recommendations.26  The theory underlying race-concordance research is 
that racial/ethnic disparities in health may be ameliorated as a result of increased mutual 
respect, trust, communication, and satisfaction, which may exist more in race-concordant 
patient-provider relationships.27  
 
 

 
 
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OBJECTIVES 
 
Using patient-centered racially distinct educational videos on SCD and ICD therapy, we will 
compare in black patients the effect of the video intervention vs. health care provider counseling 
(usual care) on 1) patient knowledge of SCD and ICD’s, 2) the decision for ICD implantation and 
associated decisional conflict, and 3) ICD receipt within 90 days. We will also explore the 
influence of racial concordance between provider and patient video participants on the decision 
for ICD implantation, associated decisional conflict, and ICD receipt at 90 days.  
 
Primary Outcome: 1. The decision for ICD implantation at 7 days among patients randomized  
to the video intervention compared with health care provider counseling (usual care) .  
 
Additional Outcomes: 1. The effect of racial concordance on the decision for ICD implantation 
2. Changes in patient knowledge (pre and post intervention). 3. Changes in decisional conflict 
(pre and post). 4. ICD receipt within 90 days of the decision for ICD implantation. 5. In-depth 
qualitative interviews of 90 patient participants that will focus on: a) knowledge of SCD and ICD 
therapy b) influences on the decision to accept or decline an ICD, c) impact of the video on the 
decision (critique of the video content) d) barriers to ICD placement following the initial decision. 
Lastly, study coordinators will assess the time spent with patients by providers in each arm of 
the study. 
 
METHODS 
 
ELIGIBILITY AND CONSENT 
Inclusion criteria:  
1) Non-hospitalized patients with ejection fraction ≤ 35% 
2) New York Heart Association class I-III heart failure 
3) Age > 21 
4) Eligible for an implantable cardioverter defibrillator (ICD) for the primary prevention of 
sudden cardiac death 
5) Self-identified race as black 
6) Provision of informed consent to participate in the study.  
 
Exclusion criteria:  
1) Life expectancy < 12 months 
2) Listed for Orthotropic Heart Transplantation (OHT) 
3) Transplant (OHT) or OHT imminent within 12 months, 
4) History of ventricular fibrillation or sustained ventricular tachycardia without reversible 
causes 
5) ICD already implanted 
6) Myocardial infarction within the last 40 days 
7) Coronary revascularization within the last 3 months 
8) Patients who are unable to understand the study procedures due to cognitive or 
language barriers 
9) Inpatients will be excluded from the study because decision-making processes are 
thought to be appreciably different in inpatients as compared with outpatients.  
10)  Plan for subcutaneous ICD (Sub-Q ICD) 
 

 
 
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SCREENING, ENROLLMENT, AND CONSENT PROCESS 
 
 
 
 
 
Figure 1: Study Processes 
Study processes are 
outlined in Fig. 1. Patients 
will be screened for 
participation/eligibility by 
the Research Assistant 
(RA), prior to the patients 
scheduled visit to the 
electrophysiology clinic. 
An introductory letter will 
be sent to potential 
patients by mail from their 
provider and research 
team. At the 
electrophysiology clinic 
visit, the RA will approach 
the patient about 
participation in the project. 
At that time (baseline 
visit), the RA will review 
study procedures and begin the consenting process. The consent process will include a full 
explanation of the research protocol and aims, as well as use of the iPad technology for the 
patient to review and sign the consent.  The patient will also review and sign a medical release 
form, to facilitate patient follow-up, if the patient is not available via phone.  In certain U.S. 
states, the patient will also review and sign a bill of rights statement.  Following the consent and 
other document(s) signature process, the patient will provide baseline demographics (age, 
gender, payer status, household income, education, distance from health care facility, method of 
transportation, current employment status and a number of other social determinants), followed 
by administration of the Health Related Quality of Life Survey (HRQOL) SF-12v2, a depression 
assessment PHQ- 2, knowledge questionnaire and the decisional conflict scale (DCS), on the 
iPad. The patient will then be randomized on the iPad to one of three study arms (see below).  
The patient will view a video (per randomization) or consult with their provider to discuss the 
ICD procedure. After exposure to their assigned arm (video or usual care), patients will be 
administered the same knowledge questionnaire on the iPad, prior to the conclusion of the visit.  
Using the iPad at the end of the visit, the RA will note the length of time the patient spent with 
the provider. 
 
BASELINE VISIT DATA 
Following consent and other processes on the iPad, the RA will collect baseline visit data from 
the patient’s medical record, including medical history, heart failure classification (NYHA), etc.  
The baseline data will be entered into the Data Collection Form (DCF).  The DCF is an 
electronic web-based form in the Registry System, used at the DCRI for data collection.  
 
 
 
 
 

 
 
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RANDOMIZATION AND BLINDING 
Participants enrolled in the study will be randomized on the iPad to 1 of 3 arms, A) video with 
black participants, B) video with white participants, or C) usual care (UC): health care provider 
counseling (Figure 2).  For the outcomes not based on racial concordance, patients in ARM A 
and ARM B (video arms) will be combined and compared with UC. Study participants will be 
blinded to differences in the 2 videos. 
 
Arm A: white video 
Arm B: black video 
Arm C: Health care provider consult only (usual care) 
 
Figure 2: Form and Content of Information Conveyed in 3 Study Arms 
 
Arm A 
Arm B 
Arm C 
 
White ICD 
Educational 
Video 
Black ICD 
Educational 
Video 
Usual 
Care 
Video featuring predominantly Black patients & health 
care professionals 
 
X 
 
Video featuring predominantly White patients & health 
care professionals 
X 
 
 
Chapter 1: Introduction 
X 
X 
 
Chapter 2: SCA and the heart’s electrical system 
X 
X 
 
Chapter 3: Are you at risk? The importance of 
ejection fraction 
X 
X 
 
Chapter 4: Therapies to prevent SCA and ICDs 
X 
X 
 
Chapter 5: Making the right decision for you – a 
patient’s perspective 
X 
X 
 
Chapter 6: Living with an ICD 
X 
X 
 
Health provider driven discussion (standard of care) 
 
 
X 
 
DATA SUBMISSION AND SITE TRAINING 
For each patient enrolled, the RA will be responsible for submitting the iPad data and entering 
the baseline visit data via the DCF within a short period of time.  Data submission for both the 
iPad and DCF will be essential to facilitate patient follow-up.  All sites will be trained on the 
VIVID Protocol, use of the iPad and Registry System, and the site materials.  The DCRI study 
team will ship all site materials, including the iPad, and provide the site team with access to the 
Registry System. 
 
 

 
 
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POST-INTERVENTION VISIT ACTIVITIES 
Outcomes Call Center (OCC) 
Following the baseline visit, the DCRI OCC interviewing team will contact patients at two 
intervals: one-week post intervention and 90-days post-intervention to ascertain information 
regarding ICD decision/implantation and to administer questionnaire(s) (see Figure 3). Medical 
record abstraction will be performed to determine ICD implantation among patients who cannot 
be reached at 90-days. For those individuals who did not receive an ICD we will seek to 
understand reasons for non-ICD implantation utilizing chart review and telephone interview. 
 
At study enrollment patients will be asked if they would like to participate in an in-depth 
qualitative interview. Qualified patients who would like to be considered for qualitative interviews 
may be contacted by a team member to schedule a convenient time to complete the interview 
(see section on in-depth interviewing below).  
 
Figure 3: Activities included in 1-Week and 90-Day Post-Intervention Follow-Up Interviews 
 
1 Week Post-Intervention 
 
90 Days Post-Intervention 
Ascertain decision regarding ICD 
implantation 
Administer DCS 
Administer knowledge questionnaire 
Reassess patient interests to participate in 
in-depth interview 
 
Patient information will be made 
available to qualitative research 
team member for potential follow-up 
contact (assuming eligibility criteria 
are met) 
 
Ascertain whether ICD was implanted 
Offer patients with discordant ICD 
decision/implantation opportunity to complete 
in-depth interview or those who were initially 
unsure in their decision. 
 
Patient information will be made 
available to qualitative research team 
member for potential follow-up contact 
(assuming eligibility criteria are met) 
 
 
IN-DEPTH INTERVIEWS 
To better understand patient decision-making processes regarding whether an ICD is right for 
them, we will invite some VIVID study participants to complete one or two in-depth interviews 
(IDIs) by telephone. During the interviews, we will ask participants about factors that were 
important to them in the decision-making process (see Interview Guide). These interviews will 
last between 45 and 90 minutes and participants will be compensated for their time. Not all 
VIVID study participants will be asked to complete these in-depth interviews. Rather, we will 
purposively select participants to ensure that we interview a diverse sample of patients. 
Sampling, interviewing time points, interview content, and compensation information is provided 
in Figure 4.  
 
RECRUITMENT 
Our goal is to recruit up to 90 VIVID participants – 30 who initially accept the ICD, 30 who 
initially refuse, and 30 who are undecided. Beyond this initial screen, we will select participants 
within each category to ensure that we have gender, age, and educational diversity. For 
example, if we have already interviewed 20 highly educated males, we will not contact the next 
highly educated male. All of this screening will take place before any member of our team 
contacts a participant. 

 
 
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All participants who indicate a willingness to be contacted for an interview will be eligible for 
both the 1st follow-up qualitative interview at 1-week and the 2nd follow-up interview at 90 days. 
Participants who complete the 1st follow-up interview will be flagged in the call-center system. 
The call center will see these flags when they complete their call at 90 days and confirm that the 
participant is willing to complete the 2nd interview. The call center can relay this information to 
the interview team, who will then schedule the 2nd interview with the participant. If not enough 
participants who completed the 1st follow up interview make a final decision about ICD 
implantation that is discordant with their original decision, the study team will follow up with 
participants who made a discordant decision and who agreed to be contacted for an interview, 
but who were not contacted for the 1st follow-up interview.  
   
Figure 4: In-Depth Interview Design  
 
 
Round 1 Interviews 
 
Round 2 Interviews 
Sampling 
Up to 90 IDIs, stratified by initial ICD 
decision: 
 
30 Acceptors 
 
30 Refusers  
 
30 Unsure 
Within each group, patients will be 
purposively samples to ensure we 
speak to a diverse range of 
participants (e.g., based on region, 
gender, education level, etc.) 
Up to 60 follow-up IDIs, to be 
completed with a sub-set of patients. 
Follow-up interviews will be 
completed with three groups of 
patients (with their consent): 
 
Patients who were originally 
unsure about ICD 
implantation 
 
Discordant Cases 
- 
Patients who originally 
accepted ICD but had not 
had it implanted at               
-day follow-up 
- 
Patients who originally 
rejected ICD but had it 
implanted at 90-day 
follow-up 
Interview 
Time Points 
Consenting patients will be 
contacted within a few days of their 
1-week follow-up to schedule a time 
to complete the IDI 
Consenting patients will be contacted 
within a few days of their 90-day 
follow-up to schedule a time to 
complete the IDI 
Content 
- Examine thoughts and opinions 
regarding educational component 
(health care provider counseling, 
video only) 
- Explore considerations important 
to ICD decision-making process 
- Interview Guide, for use by the 
DCRI Team  
- For patients originally unsure 
about an ICD, better understand 
processes/considerations that 
ultimately led them to accept or 
refuse the ICD 
- For discordant cases, examine 
factors that led to shift in initial 
acceptance/refusal decision. 
Duration 
Between 60-90 minutes 
Between 30-45 minutes 
Compensation Patients will be compensated $50 
for their time. 
Patients will be compensated $25 for 
their time 
Consent 
The original consent form includes a description of IDI opportunities. At one-
week/90-day telephone call, the interviewer will ask the participant if he/she 
is interested in completing an IDI (see In-Depth Script Language). Interested 
patients who also meet inclusion criteria may then be contacted by the IDI 

 
 
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interviewer, who will further describe the interview and answer patient 
questions (see Information Sheet, which interviewer will discuss by phone 
and send to participant by email or traditional mail). Telephone interviews 
will be scheduled for participants who wish to complete the interview. 
 
 
INTERVENTIONS 
 
BLACK INDIVIDUAL FOCUSED ICD EDUCATIONAL VIDEO 
(25 minutes): 
The patients and health care professionals in the video will be predominantly black.  This video 
will be available on the iPad, if the patient is randomized to watch this video.  For site training, 
the video is available on YouTube.  Enter “ICD YouTube” into web browser.  Click on the ICD –
YouTube link that states: African American by Duke Clinical Research Institute. Additionally, we 
have both videos in DVD format if preferred by sites. 
 
Chapter 1  Introduction 
 
Chapter 2  Sudden cardiac arrest (SCA) and the heart’s electrical system. 
Indicates normal components of electrical system (SA node, AV mode, is bundle) 
Discusses ventricular arrhythmias  
 
Chapter 3  Are you at risk? The importance of ejection fraction (EF)  
Discusses the association between EF and SCA. Ejection fraction as a measure of heart 
function 
 
Chapter 4  Therapies to prevent SCA and implantable cardioverter defibrillators (ICDs) 
The efficacy of medical therapy (b-blockers and ace inhibitors in prevention of SCA in patients 
with left ventricular dysfunction. Describes the ICD and how it works and the implantation 
procedure and potential complications 
  
Chapter 5  Making the right decision for you: a patient’s perspective 
Patients will discuss their decision-making process regarding ICD placement. 
 
Chapter 6  Living with an ICD  
Patient testimonial about what a shock feels like. How is life different with an ICD. 
Details about remote monitoring and device follow up. 
 
The video will consist of patient testimonials, educational segments with visual animation, 
physician commentary, and narration. 
 
WHITE INDIVIDUAL FOCUSED ICD EDUCATIONAL VIDEO  
(25 minutes): 
Same content as above with predominantly white participants.  This video will be available on 
the iPad, if the patient is randomized to watch this video.  For site training, the video is available 
on YouTube.  Enter “ICD YouTube” into web browser.  Click on the ICD –YouTube link that 
states: Caucasian by Duke Clinical Research Institute.  Additionally, we have both videos in 
DVD format if preferred by sites. 
 

 
 
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USUAL CARE  
Health provider driven discussion, which is the predominant counseling mode utilized at 
participating sites. 
 
STUDY INSTRUMENTS 
 
KNOWLEDGE QUESTIONNAIRE  
We constructed a 13-item knowledge assessment tool to determine participants’ knowledge of 
SCA, associated risk factors, and ICD therapy (Aim 1) (Appendix A). Potential answers for each 
question are True, False or Don’t Know; for the purposes of the final results “don’t know”, 
answers will be scored as incorrect.  A group of health care providers, ICD patients, and general 
public members has reviewed this tool for clarity, accuracy and relevance of content.  
Additionally, our stakeholder advisory panel reviewed the content and approved the final version 
of this tool. To assess the change in knowledge, the same questionnaire will be administered 
immediately before and after the intervention. Additionally, participants will be contacted at 1-
week post intervention, and the same questionnaire will be administered to assess retention of 
information. 
 
DECISIONAL CONFLICT SCALE 
Since there is no existing decisional conflict scale (DCS) for assessing decisional conflict 
associated with ICD implantation, we have modified a previously validated DCS used for 
decision-making in breast cancer screening, influenza vaccination, and coronary 
revascularization procedures.  This tool was also developed with the assistance of our patient, 
provider and general public focus groups and our stakeholder advisory panel.  This DCS was 
tested in our pilot study and performed well. The DCS will measure the effect of the video on 
decisional conflict and the decision for ICD placement.  The overarching goals of the DCS are to 
assess overall decisional conflict measured through five subscales: 1) informed subscale 2) 
values clarity subscale,  3) support subscale, 4) uncertainty subscale and 5) effective decision 
subscale. Prior to the intervention and at 1-week post intervention, participants will be asked to 
give their decision for ICD implantation (yes, no, unsure) followed by the administration of the 
DCS.  Respondents will be asked to reflect on their decision and respond to the DCS questions 
using a 5-point Likert scale.  Responses to each statement are scored 0 (strongly agree) to 4 
(strongly disagree). Total scores range from 0 to 100, with higher scores indicating greater 
decisional conflict (Appendix B). We will compare the delta change pre to post DCS scores 
across study arms. To determine the effect of racial concordance between video participants 
(physicians and patients with ICD’s and their families in the video) and study participants we will 
compare the delta change in pre and post DCS scores, decision for ICD implantation, and ICD 
receipt within 90 days of the decision in racially concordant intervention compared with racially 
discordant intervention. 
 
IN-DEPTH INTERVIEW GUIDE 
The Round 1 in-depth Interview Guide is designed to elicit patient perspectives on the 
educational information they received regarding the ICD, including information that was 
reassuring, concerning, confusing, etc. Patients randomized to a video arm will be asked 
specific questions about the video component. All patients will be asked questions regarding the 
conversation they had with their provider. In addition, patients will be asked a series of 
questions to better understand factors and individuals important to their ICD decision. The guide 

 
 
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draws from questions used in previous qualitative studies on ICD decision-making 29, 30 and has 
been reviewed by the grant’s advisory council. 
 
STATISTICAL ANALYSIS 
 
SAMPLE SIZE AND POWER CALCULATIONS 
We will randomize self-identified black outpatients with primary prevention indication for ICD in a 
1:1:1 fashion to watch a video with white participants, a video with black participants, or a health 
care provider counseling (usual care). Approximately 480 patients will be enrolled from up to 15 
active sites across the Unites States.  
 
Power calculations for this study were based on the assumption of 160 patients in each of the 
following three treatment arms: 
A. video with predominantly white participants (N = 160) 
B. video with predominantly black participants (N = 160) 
C. usual care (N = 160) 
 
The sample size has been determined to provide a reasonable level of confidence for detecting 
clinically important differences in decision ICD implantation outcome between groups if such 
differences indeed exist.  We also have substantial power for comparison of additional 
outcomes.  In the pilot study 60% of black patients in the video group said yes to ICD placement 
compared with 43% in the UC arm. We estimated a 15-20% increase in the proportion of 
patients accepting ICD implantation in the video group could change practice patterns. Similarly, 
a 15-20% higher acceptance for ICD implantation in the racially concordant video group 
compared with the discordant group would be meaningful. Based on the proportion of patients 
indicating yes to ICD therapy in each arm of the pilot study and estimating an effect size of 17-
20% to achieve 90% power, the sample size in the UC and each video arm should be between 
160 (17%) and 115 (20%). Using the same proportions of yes responses from the combined 
video groups (60%) an absolute difference of 20% would imply that the proportion of yes 
responses in the concordant video is 70% and 50% in the discordant video.   For these 
proportions, to achieve 90% power, we need 148 subjects in each video group to detect 20% 
absolute improvement in concordant video group compared to discordant video group. Thus a 
total sample size of 480 (160 black video, 160 white video, 160 UC) provides excellent power 
for the decision for ICD implantation. 
 
We will conduct Round 1 in-depth interviews with 30 patients who originally accept, refuse, and 
are unsure about ICD implantation, for a total of 90 interviews. This sample size is expected to 
be sufficient to achieve thematic saturation in the qualitative data31. Patients participating in an 
in-depth interview will be purposively selected to ensure we collect a wide range of experiences 
from a diverse subset of individuals (e.g., education, gender, region, etc.). Round 2 interviews 
will be conducted (with their consent) with up to 60 participants who completed the first 
interview. The 30 individuals initially unsure about ICD implantation will be invited to complete a 
follow-up interview, to better understand what factors ultimately influenced their final decision. 
Additionally, any Round 1 interviewee whose 90-day ICD status differed from their 1-week 
decision (i.e., acceptors who did not have device implanted at 90 days and rejecters who did 
have device implanted at 90 days), will also be invited to complete an additional interview to 
understand factors that led to ultimate outcome. 
 

 
 
Version February 27, 2020 
16 
 
The primary outcome will be the decision for ICD implantation at 7 days. Other outcomes 
include: the effect of racial concordance on the decision for ICD implantation, changes in patient 
knowledge (pre and post intervention), decisional conflict, and ICD receipt within 90 days of the 
decision for ICD implantation. The in-depth interviews will focus on: 1) knowledge of SCD and 
ICD therapy, 2) influences on the decision to accept or decline an ICD, 3) impact of the video on 
the decision (critique of the video content) 4) barriers to ICD placement following the initial 
decision. Lastly, study coordinators will assess the time spent with patients by providers in each 
arm of the study. 
 
Analysis Plan: For the primary outcome, the proportion of patients saying “yes” to ICD will be 
compared between patients receiving the ICD video intervention (arms A + B) and patients 
receiving standard of care (arm C). The two proportions will be compared with the Pearson chi-
square test.  We do not expect small counts in light of the pilot study results but, if necessary, 
the Fisher Exact Test will be used. In addition to p-value we will provide estimates of proportions 
with their confidence intervals (exact confidence intervals will be used if needed). 
 
EFFECT OF RACIAL CONCORDANCE 
As a secondary outcome, we will compare the proportions of individuals saying yes to ICD 
implant in the racially concordant video (A) and the racially discordant video (B). The two 
proportions will be compared with the Pearson chi-square test.  We do not expect small counts 
in light of the pilot study results but, if necessary, the Fisher Exact Test will be used. In addition 
to p-value we will provide estimates of proportions with their confidence intervals (exact 
confidence intervals will be used if needed). At an interim analysis based on the rate of patient 
accrual and projected sample size, the effect of racial concordance on the decision for ICD 
implantation \was changed from a co-primary outcome to a secondary outcome.  
 
KNOWLEDGE QUESTIONNAIRE  
To test the hypothesis that a patient centered educational video can improve patients’ 
knowledge of SCD and ICDs we developed a questionnaire to assess knowledge of SCA and 
ICD therapy. This short (13-item) questionnaire comprises true/false statements designed to 
measure participants’ comprehension of SCD, associated risk factors, and treatment options 
including ICD therapy. Possible scores vary from 0 to 13, with a higher score indicating better 
knowledge. Potential answers for each question are (true, false or don’t know); “don’t know” 
answers will receive a score of 0 while correct true and false responses will receive a score of 1. 
In the pilot study the test had excellent reliability with a correlation coefficient of 0.9. To assess 
the change in knowledge, the same questionnaire will be administered immediately before and 
after the exposure to the video or UC. Additionally, participants will be contacted at 1-week post 
enrollment, and the same questionnaire will be administered to assess retention of information.  
Analysis plan: To determine the effect of the video on knowledge of SCD and ICDs: The 
pre/post intervention mean change in correct responses will be compared between combined 
video groups (N=320) and usual care group (N=160). Comparisons of these continuous 
measures will be performed with a two-tailed t-test (or Wilcoxon rank sum test if substantial 
departure from normality is noted). 
 
Outcomes: Mean and standard deviation of correct answers on the knowledge questionnaire 
pre and post intervention in the combined video group with UC. 
 
Sample size and power estimation: Sample size and power estimates are based on the 
findings from the pilot study results for black participants. In the pilot study, among black 
patients, there was an improvement in the number of correct responses on the knowledge 

 
 
Version February 27, 2020 
17 
 
questionnaire from baseline to post intervention in both the video and the UC arms, mean 
standard deviation (SD) 8.4± 2.7 to 10.8± 2.1(video group), 7.4±3.9 to 9.7±2.9 usual care (p-
value comparing video and UC NS).  Based on these data and considering two-tailed equal 
variances t-test and 0.05 type I error, a sample size of 480 patients will have 99% power or 
higher to detect a mean test score difference between arms of 1.5 with SD equal to 2.5, 3.0, or 
3.5. For a mean difference between video and usual care arms equal to 1.0, power remains at 
99%, 93%, and 84%, respectively across SD of 2.5, 3.0 or 3.5. 
 
DECISIONAL CONFLICT SCALE  
We will use the DCS to measure decisional conflict. The scale measures a person’s perception 
of the difficulty in making a decision, the extent to which they feel uncertain about treatment 
options, are knowledgeable about the risks and benefits of options, clear about personal values, 
and supported in decision making; the scale has demonstrated good reliability (Cronbach’ s 
alpha coefficients > 0.78) and predictive validity. Higher scores indicate greater decisional 
conflict and patients experiencing decisional conflict are more likely to change their minds, delay 
decisions, express regret, and fail knowledge tests. Patients will be administered the DCS pre 
intervention at the baseline enrollment visit, and post intervention, 1-week post enrollment. 
Respondents will be asked to reflect on their decision and respond to the DCS questions using 
a 5-point Likert scale. Responses to each statement are scored 0 (strongly agree) to 4 (strongly 
disagree). Total scores range from 0 to 100, with higher scores indicating greater decisional 
conflict.  Analysis Plan: To determine differences in decisional conflict, each group’ s scores 
will be compared using independent samples t -test at two time points or Wilcoxon rank sum 
test if substantial departure from normality is noted. The first comparison will be within group 
(pre and post intervention) followed by 2) between group differences in the change scores using 
analysis of covariance (ANCOVA) that adjust for baseline scores. All quantitative tests will be 
two-sided and conducted at the 5% level of significance. Due to the secondary nature of these 
comparisons, there will be no adjustment for type I error.  However, it is important to note that all 
these group comparisons are pre-specified and results of all attempted comparisons will be 
reported.  
 
Sample size estimates: 
In the pilot study, among black patients, the mean and standard deviation DCS scores for UC 
and video groups were 36.0 ± 3.2 and 33.7 ± 4.3 respectively. Based on these data and 
considering two-tailed equal variances t-test and 0.05 type I error, a sample size of 480 patients 
will have 99% power or higher for a mean DCS difference between arms of 3.0 across standard 
deviations of 2.5-5.0. For a mean difference between video and usual care arms equal to 1.0, 
SD 2.5, power remains at >99%. 
 
ICD IMPLANTATION RATES 
Compare the proportion of patients with an ICD implanted within 90 days of study enrollment in 
UC vs. combined video group.  
Analysis Plan: To determine the differences in implantation rates in video versus UC arms, 
proportions will be compared with the Pearson chi-square test.  
Outcomes: Proportion of patients with an ICD implanted between groups (video combined 
N=320, UC N=160). 
 
IN-DEPTH INTERVIEWS ANALYSIS 

 
 
Version February 27, 2020 
18 
 
All audio recordings of in-depth interviews will be transcribed and redacted to remove any 
identifying information. The qualitative research team will then engage in an iterative, robust 
process to code and analyze interview transcripts: 
 
CODING 
Each interview transcript will be coded with both structural (question-based) and thematic codes 
using qualitative research software, NVivo 10. Specifically, we will first assign structural codes 
throughout the text of each transcript to delineate each question and corresponding response 
based on our interview guide. Next, we will create a thematic codebook based on the 
substantive content of the transcriptions and the research objectives. Researchers will read the 
first three transcripts and then discuss and develop an initial set of codes. These will be 
compiled in a codebook that contains the code name, definition, details concerning when to use 
and not use the code and example text to which the code has been applied. Working 
independently, two members of the research team will use the codebook to apply the codes to 
the transcripts and use Holsti’s method31 to assess inter-coder agreement. Any discrepancies in 
coding application will be discussed and resolved by the research team, and revisions made to 
the codebook as necessary. This process will be repeated in sets of 3-5 transcripts, with 
modifications to the codebook and recoding of the transcripts as needed to capture any 
additions or refinements. Interview questions and/or probes may also be modified or added 
depending on initial findings to ensure research objectives are met (18 months). 
 
QUALITATIVE ANALYSIS 
Applied thematic analysis will be used to analyze the coded interviews. Analysis may include 
running queries or generating code reports, completion of inter-coder reliability assessments, 
development of code summary tables or memos, and potentially any second-pass coding 
required. Interim results will be shared and discussed with the VIVID team to inform the future 
direction of the research. 
 
ANTICIPATED SITE REGULATORY AND PERFORMANCE COMMITMENT 
 
Enrollment is anticipated to take approximately 18 months.  The study will enroll 480 patients 
from 12 active study sites, averaging 27 patients a month for a mean of 40 patients enrolled per 
site.  
 
SITE COMMITMENT 
Sites will be expected to: 
1) Sign a site agreement with DCRI, which includes site payment benchmarks, specifying 
IRB fees and site payment information.                                       
2) Obtain IRB Approval prior to enrolling any patients and maintain approval throughout the 
study. 
3) Screen patients, and obtain informed consent and contact information from all patients, 
via the provided iPad  
4) Have institution Wi-Fi access and ability to use the iPad to submit signed informed 
consent, patient contact information, and questionnaires to DCRI  
5) Use a web-based EDC system to submit the DCF. 
 
SITE REGULATORY AND PERFORMANCE REQUIREMENTS 

 
 
Version February 27, 2020 
19 
 
Once regulatory requirements are met, training is completed, and the site agreement has been 
executed, the site will be activated for enrollment.  All active sites are responsible for obtaining 
and maintaining IRB approval from their local or central IRB.  In addition, sites are expected to 
follow Good Clinical Practice (GCP).    
 
Failure to comply with the regulatory or performance requirements above will result in an 
internal review by Dr. Thomas and the DCRI Study Team.  
 
 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
RISK/BENEFIT ASSESSMENT OF QUALITATIVE INTERVIEW  
There are no physical risks involved in this study. There is a very small risk that interview 
responses could inadvertently be disclosed outside the study in an identifiable way. We believe 
these risks to be minimal. As described in the next section, we will take several steps to protect 
the privacy of our participants and minimize any risks to confidentiality. 
 
There is also a risk that some participants may feel uncomfortable answering questions 
regarding their ICD decision. To reduce this risk, the participant will be able to skip any interview 
questions they do not wish to answer and can stop participating at any time. Some participants 
may also seek interviewer input regarding the “right” decision. To minimize this risk, the 
interviewer’s introductory script will include information about his/her limited role and credentials 
(e.g., not a medical doctor or expert in the field, role only to understand how patients think 
through these topics).  
 
This research is not expected to provide direct benefits to participants. However, by soliciting 
feedback about the ICD decision-making process, we hope our findings will better enable 
prospective recipients of ICDs to receive the information most helpful to informing their 
treatment decision. 
 
PRIVACY, DATA STORAGE, & CONFIDENTIALITY 
We will take many steps to maintain the privacy of our research participants and the 
confidentiality of the information they share. In particular, we will assign a code number to all 
interview materials. The only connection between the code number and direct identifiers will be 
a password-protected linkage file, stored at the Duke Clinical Research Institute (DCRI) and 
accessible only by study personnel. The linkage file will be kept separate from interview data, 
and will be destroyed upon completion of the project. 
 
We will follow the data storage procedures described below, as well as assure compliance with 
the VIVID research data security plan regarding the iPads, iPad security and data 
transmissions: 
 
 
Paper study records will be stored in locked areas accessible only by the study team. 
Only key-card access is permitted within the DCRI. Secured waste receptacles are 
available on each floor for expired confidential printouts; this waste is shredded weekly. 
 
Electronic data will be stored on secure computers at the DCRI. The following describes 
DCRI data storage and security procedures, which are designed to maintain the 
confidentiality of research data. By restricting access to these confidential data, the 

 
 
Version February 27, 2020 
20 
 
DCRI Network Infrastructure serves as the principal means of safeguarding this 
information from improper use or disclosure. 
o The DCRI has extensive electronic data safeguard procedures in place. All data are 
securely stored on Unix servers (currently, Solaris 9 and 10 operating systems) that 
are behind the Duke Protected Health Information (PHI) firewall. 
o At point of entry at the firewall, policy directs the denial or acceptance of certain 
types of Internet traffic from specific sponsors or sources. Connections to certain 
sites are also restricted. The router has access lists and commands to deny or permit 
traffic. Internal network software continually monitors the Intranet for the presence of 
virus' or worms and electronically quarantines any infected device. 
o All users are required to have strong passwords, changed every 90 days, and not 
reused for 3 years. The system tools enforce the strong password provision at the 
time of password creation. Access to data is based on a person's role and need to 
know. All file and directory access is controlled by groups and users rights. Users 
must have the proper access rights to read, create, and modify files. All work areas 
are secured with electronic key access. Secure recycling is provided on each floor 
for sensitive paper disposal. 
o The Unix servers are physically located in a secure IT server room with emergency 
power, non-liquid fire suppression, and authorization-based limited access. Server 
room access includes an audit trail. 
o All users are authenticated, authorized, and accounted on the DCRI domain. Remote 
Access at the DCRI is granted one of two methods and only for DCRI authenticated 
individuals. The first method is a VPN (Virtual Private Network) connection (Firepass 
from F5). A VPN allows users to form an encrypted network connection via the 
Internet backbone. The Firepass VPN software checks the client's internal virus 
protection software and will not allow inadequately controlled clients to access the 
DCRI. The second method is Citrix access (Cisco Systems). Citrix clients use an ICA 
(Independent Computing Architecture) client. Once again, all connections are 
encrypted. Client and server data is secure while the connection is maintained. 
These technologies are in place at DCRI and are fully functional. Wireless (Wi-Fi) 
access to the DCRI is only available under the VPN or Citrix routes. 
Reports, articles, and presentations of the study findings will include aggregate results only, and 
we will apply significant attention to ensuring that responses cannot be attributed to a particular 
panelist through direct or indirect inference. 
 
ALTERNATIVES TO THE IPAD AND PROCEDURES 
 
Patients who appear uncomfortable with the iPad consent process may, at the site’s discretion, 
be offered supplemental consent discussions and support to ensure comprehension and 
agreement with participation.  However, consent signature will still occur via the iPad so that 
data collection proceeds as outlined above.  No alternative methods for consent or data 
collection will be available.  Thus, patients who are not willing or able to sign the consent using 
the iPad will be unable to participate. 
 
 
 
 

 
 
Version February 27, 2020 
21 
 
REFERENCES 
 
1. 
Thomas KL, Al-Khatib SM, Kelsey RC, 2nd, et al. Racial disparity in the utilization of 
implantable-cardioverter defibrillators among patients with prior myocardial infarction and 
an ejection fraction of <or=35%. Am J Cardiol. Sep 15 2007;100(6):924-929. 
2. 
Hernandez AF, Fonarow GC, Liang L, et al. Sex and racial differences in the use of 
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JAMA. Oct 3 2007; 298(13):1525-1532. 
3. 
Whittle J, Conigliaro J, Good CB, Joswiak M. Do patient preferences contribute to racial 
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Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-
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Cooper-Patrick L, Gallo JJ, Gonzales JJ, et al. Race, gender, and partnership in the 
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Gordon HS, Street RL, Jr., Sharf BF, Souchek J. Racial differences in doctors' 
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Bernstein SJ, Skarupski KA, Grayson CE, Starling MR, Bates ER, Eagle KA. A 
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angiography: effects on outcomes of care. Health Expect. Jun 1998;1(1):50-61. 
9. 
Ilic D, Egberts K, McKenzie JE, Risbridger G, Green S. Informing men about prostate 
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Intern Med. Apr 2008;23(4):466-471. 
10. 
O'Connor AM. User Manual - Decisional Conflict Scale. Downloaded from 
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11. 
Montgomery AA, Fahey T, Peters TJ. A factorial randomised controlled trial of decision 
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Br J Gen Pract. Jun 2003;53(491):446-453. 
 
12.  
 Katz JN. Patient preferences and health disparities. JAMA : the journal of the American 
Medical Association. 2001;286:1506-1509 
13. 
Ferguson JA, Weinberger M, Westmoreland GR, Mamlin LA, Segar DS, Greene JY, 
Martin DK, Tierney WM. Racial disparity in cardiac decision making: Results from patient 
focus groups. Archives of internal medicine. 1998;158:1450-1453 
14. 
Gordon HS, Paterniti DA, Wray NP. Race and patient refusal of invasive cardiac 
procedures. Journal of general internal medicine. 2004;19:962-966 
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Whittle J, Conigliaro J, Good CB, Joswiak M. Do patient preferences contribute to racial 
differences in cardiovascular procedure use? Journal of general internal medicine. 
1997;12:267-273 
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Armstrong K, Hughes-Halbert C, Asch DA. Patient preferences can be misleading as 
explanations for racial disparities in health care. Archives of internal medicine. 
2006;166:950-954 
17. 
Rathore SS, Ordin DL, Krumholz HM. Race and sex differences in the refusal of cardiac 
catheterization among elderly patients hospitalized with acute myocardial infarction. 
American heart journal. 2002;144:1052-1056 

 
 
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18. 
Heidenreich PA, Shlipak MG, Geppert J, McClellan M. Racial and sex differences in 
refusal of coronary angiography. Am J Med. 2002;113:200-207 
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Maynard C, Fisher LD, Passamani ER, Pullum T. Blacks in the coronary artery surgery 
study (cass): Race and clinical decision making. Am J Public Health. 1986;76:1446-1448 
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Kilbourne AM, Switzer G, Hyman K, Crowley-Matoka M, Fine MJ. Advancing health 
disparities research within the health care system: A conceptual framework. American 
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21. 
Margolis ML, Christie JD, Silvestri GA, Kaiser L, Santiago S, Hansen-Flaschen J. Racial 
differences pertaining to a belief about lung cancer surgery: Results of a multicenter 
survey. Annals of internal medicine. 2003;139:558-563 
22. 
Matlock DD, Nowels CT, Masoudi FA, Sauer WH, Bekelman DB, Main DS, Kutner JS. 
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defibrillators: A qualitative study. Pacing and clinical electrophysiology : PACE. 
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23. 
M. VR. Research on the provider contribution to race/ethnicity disparities in medical 
care. . Medical care. 2002:140-151 
24. 
Pratto F BJ. Ja. Stereotyping based on apparently individuating information: Trait and 
global components of sex stereotypes under attention overload. J Exp Soc Psychol. 
1991 
25. 
Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia 
computer programs to reduce health disparities: Opportunities and challenges. Patient 
Educ Couns. 2011;85:323-330 
26. 
Street RL, Jr., O'Malley KJ, Cooper LA, Haidet P. Understanding concordance in patient-
physician relationships: Personal and ethnic dimensions of shared identity. Ann Fam 
Med. 2008;6:198-205 
27. 
Meghani SH, Brooks JM, Gipson-Jones T, Waite R, Whitfield-Harris L, Deatrick JA. 
Patient-provider race-concordance: Does it matter in improving minority patients' health 
outcomes? Ethn Health. 2009;14:107-130 
28. 
Schulman KA, Berlin JA, Harless W, Kerner JF, Sistrunk S, Gersh BJ, Dube R, 
Taleghani CK, Burke JE, Williams S, Eisenberg JM, Escarce JJ. The effect of race and 
sex on physicians' recommendations for cardiac catheterization. The New England 
journal of medicine. 1999;340:618-626 
29.      Carroll SL, Strachan PH, de Laat S, Schwartz L, Arthur HM. Patients' decision making to 
accept or decline an implantable cardioverter defibrillator for primary prevention of 
sudden cardiac death. Health Expect. 2013; 16(1):69-79. doi: 10.1111/j.1369-
7625.2011.00703.x. Epub 2011 Jun 7. 
30.      Yuhas, J., et al. "Patients’ Attitudes and Perceptions of Implantable 
Cardioverter‐Defibrillators: Potential Barriers to Appropriate Primary 
Prophylaxis." Pacing and Clinical Electrophysiology. 2012;35: 1179-1187. 
31.      Strauss A, Corbin J, eds. Basics of Qualitative Research: Techniques and Procedures for 
Developing Grounded Theory, 2nd edition. Thousand Oaks, CA: Sage Publications; 
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31.      Holsti OR. Content analysis for the social sciences and humanities. Reading, MA: 
Addison-Wesley Publishing Company; 1969 
 
 
 

 
 
Version February 27, 2020 
23 
 
APPENDIX A: KNOWLEDGE QUESTIONNAIRE 
 
True 
False 
Don’t 
Know 
1. A sudden cardiac arrest is the same as a 
myocardial infarction (heart attack).  
 
 
 
2. Conditions that place a person at risk for sudden 
cardiac arrest include all of the following: history of 
a heart attack, family history of cardiac arrest, 
weakened heart muscle. 
 
 
 
3. Ventricular tachycardia and ventricular fibrillation 
are abnormal heartbeats (rhythms) that can lead to 
sudden cardiac arrest and possibly death. 
 
 
 
4. Sudden cardiac arrest causes more deaths each 
year than breast cancer and AIDS combined. 
 
 
 
5. An ICD could save me from sudden cardiac arrest. 
 
 
 
6. If I have an ICD, I no longer have to take my 
medications. 
 
 
 
7. The ejection fraction is a measure of how fast my 
heart beats when it is in an abnormal rhythm. 
 
 
 
8. An ejection fraction less than 30% puts me at risk 
for sudden cardiac arrest 
 
 
 
9. Having an ICD placed requires me to have open-
heart surgery. 
 
 
 
10. The ICD procedure carries some risks such as: 
puncturing a hole in the heart or lung, infection, 
stroke and bleeding. 
 
 
 
11. Once I have my ICD implanted, I have to avoid 
strong magnets or metal detectors in airports. 
 
 
 
                                                                                                
12. If your heart rhythm is ventricular tachycardia or 
ventricular fibrillation (abnormal heart rhythms 
originating from the bottom chambers of the heart), 
the ICD device should respond with a shock to the 
heart. 
 
 
 
13. My ICD needs to be checked every 3-6 months to 
ensure it is working properly and to check the 
battery status. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Version February 27, 2020 
24 
 
APPENDIX B: DECISIONAL CONFLICT SCALE 
 
Which treatment option do you prefer? 
a. ICD placement with medications 
b. No ICD, continue with medications only 
      c.   Unsure 
 
Now, thinking about the choice you are about to make/just made, please look at the following 
comments about your decision regarding placement of an implantable cardioverter defibrillator. 
Please answer how you feel about these comments by CIRCLING THE RESPONSE that best 
shows how you feel about the decision you are about to make/have just made. 
 
1. I’m aware of the 
therapies available to 
protect me from sudden 
cardiac arrest. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
2. I feel I know the benefits 
of an ICD.         
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
3. I feel I know the risks 
and potential complications 
of having an ICD 
implanted. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
4. I am clear about which 
benefits of the ICD matter 
most to me. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
5. I am clear about which 
risks and potential 
complications of the ICD 
matter most. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
6. I am clear about which is 
more important to me (the 
benefits or the risks and 
potential complications of 
and ICD) 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
7. I have enough support 
from others to make a 
decision. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
8. I am choosing without 
pressure from others. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
9. I have enough advice to 
make a decision. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
10. It’s clear what decision 
is best for me.      
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 

 
 
Version February 27, 2020 
25 
 
 
11. I feel sure about the 
decision. 
 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
12. This decision is easy 
for me to make. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
13. I feel I have made or 
will make an informed 
decision. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
14. My decision shows 
what is most important to 
me. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
15. I expect to stick with 
my decision. 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
16. I am satisfied with my 
decision 
Strongly 
agree 
0 
Agree 
1 
Neither agree 
nor disagree 
2 
Disagree 
3 
Strongly 
disagree 
4 
 

 
 
Version February 27, 2020 
26 
 
APPENDIX C: VIVID QUALITATIVE INTERVIEW GUIDE 
APPENDIX D: PROPOSED VIVID CALL CENTER SCRIPT 
APPENDIX E: VIVID STUDY INFO SHEET 
 
The above appendices are included separately.