My Recordable On-Demand Audio Discharge Instructions (MyROAD)

My Recordable On-Demand Audio Discharge Instructions (MyROAD)

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. Patients and informal caregivers receive education materials but may not act due to multiple factors. A recorded message that could be repeatedly played by patients and caregivers might increase adherence to post-discharge self-care behaviors and early 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 multiple subjective and objective clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Congestive
• Intervention / Treatment: Other: on-demand audio messages of heart failure education themes

Detailed Description

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 heart failure. 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 heart failure 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 heart failure, patients receive a heart failure handbook and a "zones" 1-page handout before discharge. In addition, they can watch multiple video clips of many heart failure topics and discuss heart failure 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 heart failure 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 purpose 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, emergency department visits and death/ cardiac transplantation/ventricular assist device, (3) 45-day quality of life (Kansas City Cardiomyopathy Questionnaire), symptoms (investigator initiated tool; used in previous research), functional status (Duke Activity Status Index) and perceived adherence to activity recommendations (investigator initiated tool; used in previous research), and (4) 7-day follow-up appointment with the healthcare provider assigned before discharge. A total of 1066 patients (968 + 10% attrition) with decompensated heart failure will be randomized to either usual care or usual care and receiving a MyROAD card at discharge.

• Study Type: Interventional
• Enrollment (Actual): 2487
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus
    • Cleveland, Ohio, United States
      • Cleveland Clinic Fairview Hospital
    • Mayfield Heights, Ohio, United States, 44124
      • Cleveland Clinic Hillcrest Hospital
    • Medina, Ohio, United States
      • Cleveland Clinic Medina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Not referred for cardiac transplantation or ventricular assist device during the index hospitalization,
• Minimum age 18 years (no upper age limit),
• Ability to read and write,
• Discharge to home or to a family member's home and has control of making self-care decisions,
• Willing to participate; which requires three (3) follow-up telephone calls post-discharge.

Exclusion Criteria:

• 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),
• Plans to discharge to assisted living apartment/center, skilled nursing facility or hospice care center,
• 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),
• Post-cardiac transplantation or ventricular assist device placement,
• Currently enrolled in another experimental heart failure research study,
• Chronic renal failure and receiving chronic hemodialysis therapy for an estimated glomerular filtration rate < 30 mL/minute/1.73 m2,
• A non-traditional form of heart failure (hypertrophic or restrictive forms of cardiomyopathy, congenital heart disease or Takotsubo cardiomyopathy).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyRoad; Receives usual care heart failure education before discharge AND a card at discharge that provided pre-recorded audio messages that can be played back on-demand on 4 themes: heart failure signs/symptoms assessment, medications, activity and exercise and diet and a general message about the importance of follow-up post discharge and following the plan of care.	Other: on-demand audio messages of heart failure education themes
No Intervention: Usual care; Receives usual care heart failure education before discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Rehospitalized With Heart Failure	Number of patients re-hospitalized with heart failure.	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge	Adherence to 7-day follow-up appointment with a healthcare provider; by medical record chart review	Discharge from hospital
Quality of Life (Health Status)	Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.	Baseline
Quality of Life (Health Status)	Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item questionnaire that measures physical limitations, symptoms, self-efficacy, social interference and quality of life. The KCCQ is a standardized score from 0 to 100 points. A score of 0 is the lowest quality of life (poor) and score of 100 is the highest quality of life.	45 day
Symptoms	29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check "do not weigh self" and "no signs or symptoms of anything abnormal". The median [Q1, Q3] number of symptoms was reported between groups.	Baseline
Symptoms	29-item list of heart failure-related symptoms. Patients were asked to consider any symptoms they experienced in the last 2 weeks and choose all that apply. Patients could also check "do not weigh self" and "no signs or symptoms of anything abnormal". The median [Q1, Q3] number of symptoms was reported between groups.	45 days
Functional Status	Duke Activity Status Index (DASI) is a 12-item questionnaire using Likert scale that determines a patient's ability to participate in common, everyday activities without difficulty including self-care activities (e.g., ambulation, housework, yard work, sexual relations, and recreational activities. This is a patient-reported tool that measures functional status in patients with heart failure. Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).	Baseline
Functional Status	Duke Activity Status Index (DASI) is a 12-item questionnaire. This is a patient-reported tool that measures functional status in patients with heart failure. Patients were called by telephone and asked to rate their ability to do daily activities (e.g., personal care, ambulation, household tasks, sexual function, and recreation). Scores range from 0 (no functional capacity = worst score) to 58.2 (highest functional capacity = best score).	45 day
Adherence to Activity Recommendations	Modified PACE tool; used in previous research. Patients were asked to self-report their perceived adherence to activity recommendations by selecting the option on a checklist that matched their activity level.	Baseline
Adherence to Activity Recommendations	Modified PACE tool; used in previous research. Patient's were contacted by telephone and asked to self-report their perceived adherence to activity recommendations.	45 day
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)	All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).	90 days
Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)	All-cause re-hospitalization, death, left ventricular assist device (LVAD), or cardiac transplant via medical record chart review; interview (telephone call).	180 days
Number of Patients Rehospitalized With Heart Failure	Number of patients rehospitalized with heart failure via chart review; interview (telephone call).	45 days
Number of Patients Rehospitalized With Heart Failure	Number of patients rehospitalized with heart failure via chart review	90 days
Number of Patients Rehospitalized With Heart Failure	Number of patients rehospitalized with heart failure via chart review; interview (telephone call).	180 days
Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit	Number of patients with all-cause rehospitalization, death, or emergency department visits within 180 days. Information is obtained via medical record chart review.	180 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: American Greetings

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 10, 2016
• First Posted (Estimated): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 16-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO