The INTERPRET Inotrope Evaluation and Research Patient Registry is a longitudinal, observational study designed to look at the demographics and outcomes of heart failure patients on inotropic therapy administered in the home or infusion suite setting. The data gathered in this registry will provide information on how a patient's quality of life and symptoms change over time while on inotrope therapy, and help healthcare providers to have a better understanding of the benefits and risks associated with bridge-to-treatment and palliative care.
Eligible patients will be consented by the site investigator or staff to participate in the Registry at the time of referral for home care. Clinical data, including dosing, symptom severity, lab values, and hospitalizations, along with data on quality-of-life and patient compliance with treatment, will be collected by the home care nurses and pharmacists. The Registry's goal is to significantly contribute to the medical understandings of heart failure treatment and to improve the quality of care for heart failure patients in the United States through active publication of registry findings and disease management approaches.
Study Type
OBSERVATIONAL
Enrollment
129
Home intravenous infusion of Dobutamine, Dopamine, or Milrinone
University of Alabama at Birmingham
Birmingham, Alabama, United States
Northwestern University, Bluhm Cardiovascular Institute
Chicago, Illinois, United States
The University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Mean time of survival post-treatment
Recording length of time on treatment (in days) from start of care at Coram to study discharge date
Time frame: Through study completion, on average 6 months
Number of re-hospitalizations
Recorded on the Pharmacy Clinical Progress Report
Time frame: Through study completion, on average 6 months
Duration of re-hospitalizations
The duration (days) of re-hospitalization visits
Time frame: Through study completion, on average 6 months
Primary cause of re-hospitalization visits
The primary cause of re-hospitalization visits following treatment will be recorded by nurse on patient clinical progress report from a drop-down list with the following options: Central venous access device malfunction, central venous access device infection, cognitive changes, fatigue, dyspnea, fever, chest pain, blood pressure instability, edema, weight gain, nausea and anorexia, and other
Time frame: Through study completion, on average 6 months
Implantable cardioverter defibrillator (ICD) activity
Number of ICD firings as recorded by nurse on patient clinical progress report
Time frame: Weekly, through study completion (an average of 6 months)
Patient reported symptom severity questionnaire
A patient completed questionnaire will be used to report the severity of the following symptoms: Pain, Fatigue, Edema, Shortness of breath (with exertion), Shortness of breath (without exertion)
Time frame: Monthly, through study completion (an average of 6 months)
Quality of life assessment: Questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center
New York, New York, United States
The patient completed Kansas City Cardiomyopathy Questionnaire will be used to report the overall patient quality of life
Time frame: Monthly, through study completion (an average of 6 months)
Concomitant medication use
Patient medication profiles will be monitored for presence or absence of additional medications other than inotropes
Time frame: Weekly, through study completion (an average of 6 months)
Additional patient symptoms
A weekly nurse completed clinical progress report will record the presence or absence of the following: increased urination at night, swollen abdomen, breathing problem when lying down to sleep, cough with frothy sputum, loss of appetite, depression, and confusion and/or memory challenges
Time frame: Weekly, through study completion (an average of 6 months)