The Inotrope Evaluation and Research Patient Registry (INTERPRET)

Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Inotrope

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Bluhm Cardiovascular Institute
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center Research Institute
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified by investigator and study staff from among patients admitted to hospital for HF that are being discharged to receive inotropic therapy in the home or infusion suite.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Coram Clinical Trials
• Collaborators: Northwestern University; University of Alabama at Birmingham; Columbia University; Icahn School of Medicine at Mount Sinai; University of Kansas Medical Center
• Investigators: Study Director: Erica Blanchard, PharmD, Coram/CVS specialty infusion

Publications and helpful links

General Publications

• Checkley et. al. CONTINUOUS HOME INTRAVENOUS INOTROPIC THERAPY DECREASES SYMPTOM SEVERITY AND MAY REDUCE HOSPITALIZATIONS IN PATIENTS WITH ADVANCED HEART FAILURE Journal of the American College of Cardiology Mar 2018, 71 (11 Supplement) A806; DOI: 10.1016/S0735-1097(18)31347-0

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2014
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dopamine; Dobutamine; Milrinone; Inotrope
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Cardiotonic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Milrinone
• Other Study ID Numbers: CT-10-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No