My Recordable On-Demand Audio Discharge Instructions — MyROAD  

Heart Failure, Congestive Clinical Trial

Official title: My Recordable On-Demand Audio Discharge Instructions (MyROAD)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

• NCT number: NCT02901314
• Study type: Interventional
• Source: The Cleveland Clinic
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Completion date: March 30, 2022