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 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 (KCCQ), symptoms (investigator initiated tool; used in previous research), functional status (DASI) 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 HF will be randomized to either usual care or usual care and receiving a MyROAD card at discharge.

• Study Type: Interventional
• Enrollment (Actual): 1073
• 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
• Genders Eligible for Study: All

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 HF 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 HF (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
• 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
heart failure rehospitalization	Chart review; interviews	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first occurrence of HF-related hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device(composite outcome)	chart review; interviews	time to first occurrence up to 30 days
functional status	Duke Activity Status Index (telephone call)	45 day
perceived adherence to activity recommendations	investigator developed tool; used in previous research (telephone call)	45 day
7-day follow-up appointment with the healthcare provider assigned before discharge	chart review; interview (telephone call)	45 day
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)	chart review; interview (telephone call)	180 days
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)	chart review; interview (telephone call)	30 days
all cause re-hospitalization or ED visit or death or cardiac transplantation/ventricular assist device (composite outcome)	chart review; interview (telephone call)	90 day
quality of life (health status)	Kansas City Cardiomyopathy Questionnaire; telephone call	45 day
Symptoms of HF	investigator developed tool; used in previous research; telephone call	45 day
time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome)	chart review; interview (telephone call)	time to first occurrence up to 180 days
heart failure re-hospitalization	chart review; interview (telephone call)	180 day
heart failure re-hospitalization	chart review; interview (telephone call)	90 day
time to first occurrence of all-cause hospitalization, ED visit or death/ cardiac transplantation/ventricular assist device (composite outcome)	chart review; interview (telephone call)	time to first occurrence up to 90 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 (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

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