Clinical trial NCT02901314: My Recordable On-Demand Audio Discharge Instructions
Official title: My Recordable On-Demand Audio Discharge Instructions (MyROAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: American Greetings
First posted: 2016-09-15
Enrollment: 2487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: usual care education versus education with a pre-recorded card with heart failure instructions
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Rehospitalized With Heart Failure
timeFrame: 30 day
Secondary outcomes:
measure: Number of Patients Scheduled for 7-day Follow-up Appointment With the Healthcare Provider Before Discharge
timeFrame: Discharge from hospital
measure: Quality of Life (Health Status)
timeFrame: Baseline
measure: Quality of Life (Health Status)
timeFrame: 45 day
measure: Symptoms
timeFrame: Baseline
measure: Symptoms
timeFrame: 45 days
measure: Functional Status
timeFrame: Baseline
measure: Functional Status
timeFrame: 45 day
measure: Adherence to Activity Recommendations
timeFrame: Baseline
measure: Adherence to Activity Recommendations
timeFrame: 45 day
measure: Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
timeFrame: 90 days
measure: Number of All-cause Re-hospitalization, Death, Left Ventricular Assist Device (LVAD), Cardiac Transplant (Composite Outcome)
timeFrame: 180 days
measure: Number of Patients Rehospitalized With Heart Failure
timeFrame: 45 days
measure: Number of Patients Rehospitalized With Heart Failure
timeFrame: 90 days
measure: Number of Patients Rehospitalized With Heart Failure
timeFrame: 180 days
measure: Number of Patients With All-cause Rehospitalization, Death or Emergency Department Visit
timeFrame: 180 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic main campus
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
city: Mayfield Heights
country: United States
facility: Cleveland Clinic Hillcrest hospital
state: Ohio
city: Medina
country: United States
facility: Cleveland Clinic Medina Hospital
state: Ohio
Study officials:
References: