The Inotrope Evaluation and Research Patient Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Inotrope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inotrope|Home intravenous infusion of Dobutamine, Dopamine, or Milrinone|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time of survival post-treatment | Recording length of time on treatment (in days) from start of care at Coram to study discharge date | Through study completion, on average 6 months | 
| Number of re-hospitalizations | Recorded on the Pharmacy Clinical Progress Report | Through study completion, on average 6 months | 
| Duration of re-hospitalizations | The duration (days) of re-hospitalization visits | 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 | 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 | 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) | Monthly, through study completion (an average of 6 months) | 
| Quality of life assessment: Questionnaire | The patient completed Kansas City Cardiomyopathy Questionnaire will be used to report the overall patient quality of life | Monthly, through study completion (an average of 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant medication use | Patient medication profiles will be monitored for presence or absence of additional medications other than inotropes | 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 | Weekly, through study completion (an average of 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inotrope, Milrinone, Dopamine, Dobutamine