Heart Failure
Conditions
Keywords
Inotrope, Milrinone, Dopamine, Dobutamine
Brief summary
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.
Detailed description
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.
Interventions
DRUGInotrope
Home intravenous infusion of Dobutamine, Dopamine, or Milrinone
Sponsors
Columbia University
Northwestern University
University of Kansas Medical Center
University of Alabama at Birmingham
Icahn School of Medicine at Mount Sinai
Coram Clinical Trials
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be prescribed inotropic treatment (milrinone, dobutamine or dopamine) * Patient must be referred to Coram for this treatment in an alternate site of care, either home or infusion suite * Patient must be willing to receive care and comply with the teaching and training necessary to administer treatment * Patient is age 18 or over
Exclusion criteria
* Patient is unable to start, or stops taking, inotropic medication * Patient and/or patient insurance will not cover cost of home inotropic treatment with Coram, or patient elects not to start treatment * Patient is under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment: Questionnaire | Monthly, through study completion (an average of 6 months) | The patient completed Kansas City Cardiomyopathy Questionnaire will be used to report the overall patient quality of life |
| Implantable cardioverter defibrillator (ICD) activity | Weekly, through study completion (an average of 6 months) | Number of ICD firings as recorded by nurse on patient clinical progress report |
| Patient reported symptom severity questionnaire | Monthly, through study completion (an average of 6 months) | 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) |
| Mean time of survival post-treatment | Through study completion, on average 6 months | Recording length of time on treatment (in days) from start of care at Coram to study discharge date |
| Number of re-hospitalizations | Through study completion, on average 6 months | Recorded on the Pharmacy Clinical Progress Report |
| Duration of re-hospitalizations | Through study completion, on average 6 months | The duration (days) of re-hospitalization visits |
| Primary cause of re-hospitalization visits | Through study completion, on average 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional patient symptoms | Weekly, through study completion (an average of 6 months) | 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 |
| Concomitant medication use | Weekly, through study completion (an average of 6 months) | Patient medication profiles will be monitored for presence or absence of additional medications other than inotropes |
Countries
United States
Outcome results
None listed