My Recordable On-Demand Audio Discharge Instructions (MyROAD)
Phase: NA
Conditions: Heart Failure, Congestive
Sponsor: The Cleveland Clinic

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Cover Page 
 
 
Study title 
My Recordable On-Demand Audio Discharge 
Instructions (MyROAD) 
National Clinical Trial number 
NCT- 02901314 
 
Date of the document 
1-20-2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Title:  My Recordable On-Demand Audio Discharge Instructions (MyROAD) 
 
 
Principal Investigator: Nancy M. Albert PhD, CCNS, CHFN, CCRN, NE-BC, FAHA, FCCM1 
 
Co-Investigators: 
Kathy Ray2  
 
 
 
 
Study Coordinator:  
Ellen Slifcak, BA, RN1 
 
1. Office of Nursing Research and Innovation 
2. Information Technology Division 
 
Cleveland Clinic, Cleveland OH 
 
Note: American Greetings, a Cleveland based company, will provide cards for the intervention 
group with the pre-recorded messages.  
 
 

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ABSTRACT 
 
Non-adherence to the heart failure (HF) plan of care after hospital discharge has been associated 
with clinical outcomes, including the combined endpoint of all-cause mortality and 
rehospitalization for decompensated HF. Most patients are discharged with a complex set of 
instructions that include multiple medications (and differing mediation administration plans), 
sodium restricted diet, fluid management actions (daily weight monitoring and in some cases, 
fluid restriction), monitoring signs and symptoms of HF, activity and exercise, and when to 
return for follow-up. At discharge, patients (and their families) may not understand that HF is 
chronic. Improvement in quality of life may be dependent on patients’ acceptance of HF as a 
chronic, irreversible condition that requires self-care monitoring and behaviors (for example, 
becoming or staying physically active), even when they feel fine. To decrease the complexity of 
understanding HF, patients receive a HF handbook and a “zones” 1-page handout before 
discharge. In addition, they can watch multiple video clips of many HF topics and discuss HF 
self-care with the hospital healthcare team. However, patients may not read (or view) education 
materials due to health literacy issues, cognitive decline, eyesight issues, fatigue or depression. 
Patients may rely on lay (family) caregivers to understand self-car expectations and be active 
partners in care. Caregivers engaged in patients’ care may not be present at discharge or may 
have preconceived or inaccurate ideas about HF self-care after discharge. A recorded message 
that could be repeatedly played by patients and caregivers might increase adherence to post-
discharge self-care behaviors and 7-day follow-up appointments, and have clinical benefits 
related to a reduction in all-cause mortality and rehospitalization. The purposes of this 
randomized, controlled study are to examine the effects of use of a novel MyROAD (Recordable 
On-Demand Audio Discharge) card, given to patients at discharge. The aims of this single-blind, 
placebo-controlled study are to examine the effects of recorded messages that can be replayed 
post discharge (delivered via the MyROAD card) on (1) 45-, 90-, and 180-day first occurrence 
and (2) time to first occurrence of all-cause and HF-related hospitalization, ED visits and death/ 
cardiac transplantation/ventricular assist device, (3) 45-day quality of life, symptoms, functional 
status and perceived adherence to activity recommendations, and (4) 7-day follow-up 
appointment with the healthcare provider assigned before discharge. A total of 1066 patients 
(968 + 10% attrition) with decompensated HF will be randomized to either usual care or usual 
care and receiving a MyROAD card at discharge.  

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INTRODUCTION    
 
Chronic heart failure (HF) is a costly diagnosis;1 especially for patients who are hospitalized due 
to decompensation. Heart failure decompensation and hospitalization place patients at high risk 
for rehospitalization, exacerbating costs of care and potential penalties associated with the 
Patient Portability Affordable Care Act.2  
 
Adherence to HF self-care maintenance (carrying out HF self-care behaviors recommended to 
patients with most etiologies of HF: limiting sodium intake per day, being active and exercising, 
managing fluids by daily weight monitoring and fluid restriction, monitoring for signs and 
symptoms of worsening HF, taking medications as ordered, and receiving follow-up care early 
after discharge) and management (calling a healthcare provider for new or worsening symptoms 
or taking actions to reduce sodium or fluid intake) behaviors were associated with improved 
clinical outcomes, including survival and fewer rehosptializations.3-5 Of note, when researchers 
studied 4 self-care behaviors in 830 patients with HF (weight monitoring, low sodium diet, fluid 
restriction and activity) at 30 days after hospital discharge, only 48% were adherent. At 18 
months, all-cause mortality or HF rehospitalization was lower among patients who were adherent 
to all 4 behaviors versus 0 or 1, 2, or 3 behaviors.4 Of behaviors, exercise was the most important 
in reaching the primary endpoint (p=0.002), and when outcomes were analyzed independently, 
18-month rehospitalization was significantly lower in patients who were adherent to the exercise 
expectations (p=0.007).4 Further, in a research study of nurses comfort in and frequency of 
providing HF self-care discharge education, activity behavior instructions ranked lowest in both 
comfort and frequency. Thus, patients may not receive activity instructions.6 In a research study 
of patient’s perceptions of activity and exercise, researchers found that patients did not 
understand activity and exercise expectations and generally, were sedentary.7 Ultimately, activity 
behaviors after hospital discharge may be an important part of self-care that requires more 
discussion, to enhance adherence.  
 
There are many reasons why patients are non-adherent to the HF plan of care. They may know 
what to do, but not how to incorporate change into their daily routine.8 Patients may have 
impaired memory, cognitive decline, lack of social support,9-11 have general or exertional 
fatigue,12 be older, have polypharmacy, poor sleep and comorbid conditions,13 and have cultural, 
socioeconomic, psychological, or physiological reasons.14 In a study that assess factors 
associated with 7-day follow-up appointment adherence, researchers used medical record and 
Centers for Medicare and Medicaid billing data and found that greater distance from the doctor’s 
office, black race, rural address, lower socioeconomic status and women were associated with 
non-adherence.15 Further, patients’ (and caregiver) acceptance of HF as a chronic condition that 
requires self-care actions, even when asymptomatic, may not be well understood; however, in 
one study, patients acceptance of HF was the only independent predictor of quality of life in the 
energy, pain, emotional reactions, sleep, social isolation and mobility domains.16  
 
In addition to the many factors that may predict non-adherence to HF self-care, at hospital 
discharge, patients may be overwhelmed with materials and messages and may be unable to 
discern what self-care behaviors to focus on. Lay caregivers may not be present or may have 
misperceptions about self-care expectations. Repetition of messages is an age-old way to 

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enhance understanding of communication.17 However, it is unknown if a card with a 
standardized recordable messages specific to HF self-care, that can be replayed repeatedly after 
discharge, will enhance knowledge of expected self-care behaviors that leads to improved 
adherence, and improved clinical outcomes after discharge.   
 
Study Purposes 
The purposes of this study are to test the effects of a novel card with recorded discharge 
instructions that can be replayed on-demand post-discharge in the home, called “My Recordable 
On-Demand Audio Discharge (MyROAD) Instructions” card. 
 
The following outcomes will be assessed:  
1. 45-, 90-, and 180-day first occurrence of post-discharge all-cause and HF hospitalization, 
emergency department [ED) visit, and death or cardiac transplantation/ ventricular assist 
device [VAD] implant),  
2. 45-, 90-, and 180-day time to first occurrence of all-cause and HF hospitalization, ED 
visit, or death/cardiac transplantation or VAD implant,  
3. 45-day quality of life, functional status and perceived adherence to activity/exercise 
recommendations,  
4. 7-day follow-up appointment with the healthcare provider assigned before discharge. 
  
Specific aims and hypotheses: 
1.      Determine the effects of MyROAD on first occurrence and time to first occurrence of all-
cause and HF hospitalization, ED visit, and death (or cardiac transplantation or VAD). 
 
Hypothesis 1a: 45-day post-discharge rehospitalization, ED visit and death will be lower 
or trend toward lower, and 90- and 180-day first occurrence of hospitalization, ED visit 
and death will be lower in the MyROAD group compared to the usual care group.  
 
Hypothesis 1b: Time to first event (rehospitalization, ED visit and death) will be longer 
in the MyROAD group compared to the usual care group at 90- and 180 days. 
 
2. 
Determine the effects of receiving repetitive HF messages via MyROAD on quality of 
life, functional status and perceived adherence to activity recommendations. 
 
Hypothesis 2a: Health-related quality of life (specifically, the clinical summary score, 
quality of life score, total symptom score -and subscales of physical limitations, symptom 
stability, symptom frequency, and symptom burden- will be higher in the intervention 
group compared to the usual care group at 45-days, reflecting improved early post-
discharge quality of life.  [Note: overall summary score (that includes the areas above and 
also self-efficacy) will be measured but are not included in the endpoint.] 
 
Hypothesis 2b: HF-related symptoms will be less prevalent in number in the MyROAD 
group compared to the usual care group at 45-days.    
 

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Hypothesis 2c: Functional status will be higher in the intervention group compared with 
the usual care group at 45-days. 
 
Hypothesis 2d: Perceived highest activity/exercise level will be higher in the 
intervention group compared with the usual care group at 45-days. 
 
3. 
Determine the effects of receiving repetitive HF messages by MyROAD on adherence to  
 
7-day follow-up appointment after index discharge. 
 
Hypothesis 3: Adherence to 7-day follow up appointment will be higher in the 
intervention group compared with the usual care group. 
 
METHODS 
Design: The study will use a 2-group, randomized, placebo-controlled, single blinded, design. 
Healthcare providers will be initially blinded to group assignment, but may learn about the card 
from patient verbalization over time, as it is not possible to blind patients to the intervention, a 
MyRoad card.   
 
In brief, the research intervention is a novel card with 4 standardized, recorded messages of HF 
discharge instructions and a general message. (see Intervention section). The messages 
themselves are not the intervention, as the HF self-care messages are general standard of care 
messages delivered in many formats to hospitalized patients at all Cleveland Clinic hospitals. It 
is the ability to re-play (and re-listen) to general messages when desired that is the intervention.   
 
Sample and Setting 
A total of 1066 patients will be enrolled (533 per group) and consist of adults with chronic HF 
(diagnosis ≥ 2 months) who are hospitalized for acute decompensated HF at the Cleveland Clinic 
main campus, Fairview Hospital, and Hillcrest Hospital. This sample size includes a 10% 
attrition rate.  
 
Patients will have decompensated HF with preserved or reduced ejection fraction when 
hospitalized and New York Heart Association FC III or ambulatory IV. Diagnosis and etiology 
of HF will be confirmed in the electronic medical record prior to enrollment. 
  
Inclusion Criteria: 
1. 
Not referred for cardiac transplantation or ventricular assist device during the index 
hospitalization, 
2. 
Minimum age 18 years (no upper age limit),  
3. 
Ability to read and write,  
4. 
Discharge to home or to a family member’s home and has control of making self-care 
decisions, 
5. 
Willing to participate; which requires three (3) follow-up telephone calls post-discharge. 
 
Exclusions:  

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1. 
Chart documented psychiatric or cognitive conditions that limit ability to understand or 
adhere to self-care recommendations (Alzheimer’s condition, dementia, schizophrenia, 
other neurological history that impairs memory), 
2. 
Plans to discharge to assisted living apartment/center, skilled nursing facility or hospice 
 
care center, 
3. 
Receiving home hospice or palliative care; or has a medical condition reflecting less than 
 
1 year of survival (cachexia, end stage liver disease or cancer or non-ambulatory New 
 
York Heart Association functional class IV heart failure), 
4. 
Post-cardiac transplantation or ventricular assist device placement, 
5. 
Currently enrolled in another experimental HF research study,  
7. 
Chronic renal failure and receiving chronic hemodialysis therapy for an estimated 
glomerular filtration rate < 30 mL/minute/1.73 m2, 
8. 
A non-traditional form of HF (hypertrophic or restrictive forms of cardiomyopathy, 
congenital heart disease or Takotsubo cardiomyopathy). 
9. 
Wheelchair bound, uses a cane or walker, or unable to carry out physical activity, 
including walking, due to a chronic disability or documented medical condition.      
 
Intervention 
MyROAD is a card that has been designed by CC innovators and American Greetings. When the 
card is opened, there is a general message that is automatically played. Within the card is a heart 
shaped cutout that has 4 buttons, one in each quadrant. When pressed, each button has audio of 
one aspect of general HF education: diet, medications, signs and symptoms of worsening 
condition and physical activity. The buttons can be pressed as desired (for approximately 2 
weeks, until the battery expires) to allow playback of messages. At the top of the heart is a space 
for the phone number of who to call with questions. CCF Marketing and Brand team has been 
involved in card art and wording including, color choices, formatting, designs and 
brandying/logos. A magnet allows the heart to adhere to metal surfaces as a visual reminder of 
self-care; see Appendix A. The script was developed by a HF expert clinician (nma) and 
reviewed and approved by Dr. Randall Starling, vice chair of Cardiology and section head of 
Heart Failure and Cardiac Transplantation in the Heart and Vascular Institute; see Appendix B. 
The speaker of the script is a professional radio voice (hired by American Greetings). The card 
material can be written on, as desired by a health care provider; for example, a nurse can write 
down the specific dietary sodium limit/day or a phone number. The HF discharge instructions are 
short, global versions of discharge instructions used by Cleveland Clinic and match current 
global discharge instruction messages on self-care found in our HF Handbook and HF zones 
sheet, used by all CC hospitals in Northeast OH. 
 
Outcomes and Measurement 
Case report forms will be used to collect all-cause and HF hospitalization, ED visit, and death (or 
cardiac transplantation or VAD) healthcare consumption and also, 7-day adherence to the 
scheduled post-discharge follow-up appointment.  
- 
Data will be collected at baseline and 45-, 90-, and 180-day days after discharge 
 
Quality of life will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).  
Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23 item questionnaire that measures 

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physical limitations, symptoms, self-efficacy, social interference and quality of life.18, 19 KCCQ 
is valid, reliable and a responsive health measure.18 When 2 generic QOL tools were compared to 
KCCQ at baseline and 6 weeks for clinical changes, the KCCQ outperformed the 2 generic tools 
(EQ-5D and Rand 12).19 Ultimately, a mean change in score by 4.5 points (higher or lower) at 6 
weeks reflected a change by 1 New York Heart Association functional class for overall summary 
score and a mean change in score by 5 points (higher or lower) at 6 weeks reflected a change by 
1 New York Heart Association functional class for clinical summary score.19 Further, in previous 
research conducted at Cleveland Clinic in a study of patients with HF and similar enrollment 
criteria, the KCCQ was highly sensitive to changes in 60-day HF-related QOL between usual 
care and a 1-liter fluid restriction groups.20   
- 
Data will be collected at baseline and 45 days after discharge 
 
Symptoms will be measured using a case report form that contains a list of commonly reported 
symptoms. Patients would place a check mark in the box of symptoms they have had in the last 7 
days. This tool is essentially 1 item and should take about 30-60 seconds to complete. The tool 
has been used in previous research by the principal investigator and in analysis, patient 
perceptions of many signs and symptoms were highly associated with functional status and  
hospitalization. 
- 
   Data will be collected at baseline and 45 days after discharge 
 
Functional status will be measured using the Duke Activity Status Index (DASI). The Duke 
Activity Status Index (DASI)21 developed in a sample of people undergoing cardiac exercise 
testing and now routinely used to assess functional status in patients with cardiac disease. The 
DASI is a 12-item questionnaire using a Likert-like scale that determines a patient’s ability to 
participate in common, everyday activities without difficulty, including self-care activities (1 
item), ambulation (4 items), housework (3 items), yard work (1 item), sexual relations (1 item), 
and recreational activities (2 items).21 Each item is weighted to reflect the metabolic equivalent 
(MET) used during the activity. A total score reflects functional status based on responses to 
each item. Scores can range from 0 (most severe functional impairment) to 58.20 (no functional 
impairment). Several investigators have investigated the reliability and validity of the DASI.21-24 
The internal consistency of the DASI measured by Cronbach’s alpha has been found to be 
acceptable in HF patients. 22 Test-retest reliability also was examined and determined to be 
acceptable in patients with HF.22 The validity of DASI was demonstrated in subjects undergoing 
graded exercise testing who demonstrated a high correlation (Spearman correlation coefficient 
from .58 to .80) with peak oxygen uptake.21 In addition, the DASI varied in a consistent manner 
according to different clinical factors known to affect patient functional capacity in patients with 
cardiac disease. 23 When DASI results were correlated with other functional and health status 
measures, moderate to strong correlations were found: New York Heart Association (r, -64; P < 
0.001); six minute walk test (r, 44; P < 0.01);  Kansas City Cardiomyopathy Questionnaire 
physical limitations component (r, 68; P < 0.001); Kansas City Cardiomyopathy Questionnaire 
clinical summary  (r, 60; P < 0.001) and estimated metabolic equivalents calculated from peak 
treadmill speed and grade (r, 46; P < 0.01).24   
- 
Data will be collected at baseline and 45 days after discharge 
 

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Perceived adherence to activity/exercise recommendations will be measured using an 
investigator-developed form that is an extension of the physical activity and exercise case report 
form used in the 2009 exercise study conducted by the PI. The modified PACE tool is a 1-item 
tool with 17 response options that requires patients to select the option that reflects the highest 
level of purposeful walking, or moderate or vigorous exercise. The original PACE tool had 11 
response options and focused only on moderate to vigorous exercise.   
- 
Data will be collected at baseline and 45 days after discharge 
 
Case report forms will be used to collect patient characteristics and medical history at baseline. 
The Charlson Comorbidity Index will be used to collect medical history. This index was 
developed to classify comorbid conditions which might change the risk of mortality.25-30 The 
score will be categorized into 3 groups (score of 1-2 = 1; 3-4 = 3; 5 or more = 5). In one study 
with 33,940 patients with ischemic heart disease, the grouping demonstrated a strong relationship 
with mortality rate.30 This data will also be used to describe the sample groups for similarity in 
acuity.   
- 
Data will be collected at baseline. 
   
Data Collection 
Medical records will be assessed for inclusion and exclusion criteria before approaching patients.  
Research personnel will explain the study in a patient’s room (private in the J building and with 
the room-separating curtain closed when a double room on Main campus or at Hillcrest or 
Fairview Hospitals). After received verbal informed consent, patients will complete baseline 
data. After completing baseline paperwork, patients will be randomly assigned to the usual care 
or usual care plus MyROAD card group using block randomization; with blocks of 20 to 
decrease the influence of external factors that could alter outcomes. The randomization 
assignment will be made by a QHS statistician.  
 
After randomization to groups: 
• Intervention group patients will receive the MyROAD card by research personnel. The card 
can be administered at the time of enrollment, there is no need to wait till day of discharge, 
since voice-recorded messages are standard care and are not individualized. Patients will also 
be instructed that their healthcare providers (including their nurse caregivers) will deliver 
usual care discharge instructions and patient education.   
• Usual care group patients will be instructed that their healthcare providers (including their 
nurse caregivers) will deliver usual care discharge instructions and patient education.   
 
7-day follow up appointments are part of usual care. A research nurse will review EMRs of 
enrolled patients between discharge and 30 days after discharge for adherence to the 7-day 
follow-up appointment. If not found, at the 45-day telephone call, data will be collected on 7-day 
follow-up appointment adherence, quality of life, functional status and adherence to 
activity/exercise recommendations (by short questionnaires) during the telephone call.  
 
45-90 and 180-day healthcare consumption will be assessed in 3 primary ways: EMR review, 
telephone contact and written paperwork mailed to patient’s home (if unable to reach patients by 
telephone: quality of life, functional status and physical activity/exercise forms-- with a self-

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addressed, pre-stamped envelope for return). In addition, death may be assessed by Social 
Security Death Index software.  
 
Sample Size 
Based on historical readmission rates among subjects receiving the current standard of care 
treatment (~ 20% and dropping slightly every year), a 30-day readmission rate of 18% is expected. 
We are also basing the sample size on an expected 90-day rehospitalization rate of 25% and a 180-
day rehospitalization rate of 35%; both of which are conservative. Sample size calculations were 
performed to show minimum sample size needed to detect a decrease of 30% at 30-days, 90-days 
and 180-days with the addition of the card. In many research studies, trends toward improvement 
are found at 30 days, but the trend is not significant till further out (90 days or 180 days). Thus, we 
are hypothesizing that a trend will be seen at 30 days, but that there will be significant differences at 
90 days and 6-months. A total sample size of 968, 734 and 468 are needed to achieve 80% power in 30-
day, 90-day and 180-day rehospitalization rates, respectively. These calculations assumed a balanced 
randomization and use of one-sided Pearson chi-square tests with a significance level of 0.05. 
Calculations were performed using SAS software (version 9.2; Cary, NC). To account for attrition in 
follow-up, sample size was increased by 10-% at 30-days and 20% at 90- and 180-days, creating 
ideal sample sizes of 1066 (533 per group; to achieve power at 30-days), 882 (441 per group; to 
achieve power at 90-days) and 562 (281 per group; to achieve power at 180-days).  
- 
Thus, our minimum sample size will be 562 subjects. If trends in outcomes are favorable, 
data collection will continue to reach the required sample size for 90-day outcomes.   
 
Analyses 
Patient characteristics will be summarized using frequencies and percentages for categorical factors, 
and means, standard deviations, and percentiles of interest for continuous measures.  Pearson chi-
square tests will be used to compare the proportion of subjects meeting the composite endpoint of 
death or at least 1 readmission by 6 months.  Secondary analyses will use Poisson regression to 
compare readmission rates (number of readmissions/follow-up days), and competing risk survival 
methods will be used to compare time to first readmission between groups.  Analyses will be 
performed assuming a 0.05 significance level. Analyses will be performed using SAS software 
(version 9.2 or higher; Cary, NC). 
 
Feasibility 
The main campus of Cleveland Clinic has a high volume of HF discharges each year. Fairview 
and Hillcrest Hospitals have moderate volumes of HF discharges, and are less likely to have 
patients who meet exclusion criteria due to enrollment in another research study or advanced HF. 
Electronic medical records allow for review of data on events that occur in all system hospitals 
and regional medical practice ambulatory care sites; decreasing the need to rely on patient recall 
of rehospitalization and emergency care events.  
 
The MyCard instructions are a global representation of standard HF discharge instructions found 
in written handouts and other sources of patient education (videos, verbal instructions from 
healthcare providers). No new information is presented; thus, the MyRoad card is an extension of 
usual care delivered in a different format that is repeatable. Patients do not need to be able to 

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read and if they are forgetful, they can replay messages multiple times before the battery cycle 
ends (around 2 weeks of frequent use).  
 
Nurse managers, clinical nursing directors and cardiologist medical directors of each hospital 
involved (7th floor J building and general medical units of main campus; multiple medical units 
of Hillcrest and Fairview Hospital—however, patients with HF are concentrated on PK2-
Progressive Care Unit [Fairview Hospital] and 5M [Hillcrest Hospital] are aware that this study 
will be starting and agreed (and were actually excited) that we are included their patients/units. 
Research personnel from the Office of Nursing Research and Innovation will be involved in 
recruitment and all data collection. The main campus has multiple research projects in place. My 
team is accustomed to working with cardiology research nurses to ensure patients are not 
approached for more than 1 research study.    
 
Self- or research nurse-administered instruments that will be completed at baseline, 45, 90 and 
180-days are short, simple and will be quick to complete. Patients may become fatigued when 
completing data collection forms; however, there are only 5 forms for patients to complete at 
baseline (quality of life, symptoms, functional status, physical activity/exercise and a case report 
form of demographic information); all of which are short (most are single page) and should not 
take more than 10 minutes to complete. The 4 forms used at 45 days should take no more than 5 
minutes to complete. We have used all instruments in previous research and do not anticipate a 
burden to patients who enroll. There is only a telephone call at 90- and 180-days. Data obtained 
from electronic medical records is consistently present, minimizing the occurrence of missing 
data.  
 
Limitations and Anticipated Problems 
Patients and caregivers may never listen to the recorded message after discharge, or loose, throw 
out or misplace the card. Patients may hear, but ignore, message content. Patients may drop out 
before the 180-day follow-up data collection. Patients in both groups may ignore self-monitoring 
and self-care messages based on past practices, implicit beliefs about how to monitor and care 
for self or misperceptions of family or friends. Analyses will be completed using “intent to treat” 
methods. In this way, we will be able to learn the effect size of the intervention among all 
patients randomized to the intervention group.   
 
No adverse effects are anticipated, as the intervention in this research is a greeting-type card that 
cannot create harm to patients. The audio script provides global messages of content used in 
usual care education and discharge instruction materials. There are no risks of adverse events 
from the intervention itself.  
 
Human Subjects Protection 
Approval by the Cleveland Clinic Institutional Review Board will be sought prior to study 
initiation. We believe this study is minimal risk as the intervention is a greeting-type card that 
repeats self-care monitoring and instruction messages that are part of usual heart failure post-
discharge care.  
 

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1 data collection form will use a research number and CCF medical record number; as it will also 
contain a phone number and address; however, all other forms only contain the research number. 
Only the research number will be recorded in the electronic database. Paper forms will be kept in 
a locked cabinet, in a locked office of the principal investigator and will be destroyed upon 
completion and publication of the study. Electronic data for analysis will use a research number; 
no patient identifiers will be used. All study results will be reported in the aggregate.  
 
SPSS will be the electronic database used to capture paper data. The database will be maintained 
for 6 years after study completion. Paper forms will be destroyed after analyses are complete.  
 
This research project may be registered in www.clinicaltrials.gov.  
 

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Timeline 
 
Work 
2016 
2017 
Feb 
Mar 
Apr 
May Jun 
Jul 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Startup 
work* 
 
 
 
 
 
 
 
 
 
 
 
 
Patient 
enrollment, 
data 
collection 
and data 
entry into 
database 
 
 
 
 
 
 
 
 
 
 
 
 
Patient 6 
month 
follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
*, secure cards (after developing wording and card designs); identify and train nurses assigned to 
project; prepare randomization cards/envelopes; ensure hospital-based nurses are trained in 
human subject protection; receive IRB for approval to conduct the study, receive support for 
cardiology directors at each hospital and develop database  
 
Timeline, continued 
 
Work 
2017 
2018 
Feb 
Mar 
Apr 
May Jun 
Jul 
Aug 
Sept 
Oct 
Nov 
Dec 
Jan 
Patient 
enrollment 
and data 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
Patient 6 
month 
follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry 
and 
cleaning 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timeline, continued 
 
Work 
2018 
Feb 
Mar Apr 
May Jun Jul 
Aug 
Data entry and cleaning 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
Abstract and presentation preparation/delivery 
(local stakeholders) 
 
 
 
 
 
 
 

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Abstract submission for national meeting 
presentation in 2018** 
 
 
 
 
 
 
 
Prepare paper for publication 
 
 
 
 
 
 
 
**, American Association of Heart Failure Nurses; American Heart Association

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Appendix A; Prototype of Card 
 
                      Front of Card (Page 1) 
 
 
Inside of page 1 (left side) 
 
 
 
 
           Page 2 (inside of card-right side) 
 
 
Back of Card (Page 2) 
 
 
 

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Appendix B. Audio Script 
CLEVELAND CLINIC – MY ROAD CARD  
Script for American Greetings – Heart Failure 
INTRO (plays audio when the card is opened) 
Cleveland Clinic cares about you and your health, so we’ve designed this message to help you 
take the best care of yourself after leaving the hospital. The messages in this card will cover 
important information regarding physical activity, diet, medication, and self-monitoring.  
Your primary medical diagnosis is heart failure. Heart failure is a chronic condition. It is 
important to take actions to improve your health and stabilize heart failure. Contact your doctor 
if you still have questions after hearing and carrying out the actions provided in this card.  
 
PHYSICAL ACTIVITY (Plays when the physical activity button is pressed) 
Physical activity is extremely important for you. Start slow with walking 10 minutes a day. Over 
the course of a month, build up to walking 30 minutes a day. Do not worry if you feel short of 
breath or have a fast heart rate as you engage in physical activity – this is all normal.  
Unless your doctor or nurse specifically advised against walking or completing other physical 
activities you should be active 5 days per week. If you feel ready for more activity beyond 
walking, you can try swimming, bicycling, or walking briskly. 
 
DIET (Plays when the diet button is pressed) 
Eat fresh foods as much as possible. Do not take in more than 2900 mg of sodium per day. Avoid 
eating frozen, boxed, bagged, or canned foods. The 6 most salty foods are breads, soups, breaded 
meats, pizza, deli meats and deli sandwiches. Please avoid these salty foods. Limit the use of 
butter and ask your server about sodium content if you eat at a restaurant. Read food labels for 
sodium content and serving size to learn if you are taking in too much sodium.  
 
MEDICATIONS (Plays when the medications button is pressed) 
Medications are a very important part of heart failure care. They keep your heart from getting 
bigger and some medications help reduce your heart size and improve your heart’s ability to 
function more normally. Even if you start feeling better, do NOT stop taking your medications. 
Also, be sure to attend your scheduled office visits so that your medications can be adjusted to 
the right dose. It is common that a dosing change is needed for 1 or more medications after 
hospital discharge.  Continue taking all of your heart failure medicines as ordered and call your 
doctor or nurse if you’re unsure about anything regarding your medications. 
 
SELF-MONITORING (Plays when the self-monitoring button is pressed)  
Weigh yourself every day. If you gain more than 4 pounds unexpectedly, call your doctor or 
nurse. 
Call your doctor or nurse if any you are experiencing any of these other symptoms:  
• New or worsening shortness of breath 
• New or worsening fatigue or leg weakness 
• New or worsening swelling in the ankles and lower legs  
• A firm abdomen around your belly button that does not poke inward easily 
• An increase or a new need to urinate at night after going to bed 
• Needing more pillows at night or needing to sleep in a recliner, and 

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• Finding yourself sitting up in bed at night to catch your breath.