INTERPRET: The Inotrope Evaluation and Research Patient Registry

Sponsor

Coram Clinical Trials (Other)

Overall Status

Completed

CT.gov ID

NCT03160846

Collaborator

Columbia University (Other), Northwestern University (Other), University of Kansas Medical Center (Other), University of Alabama at Birmingham (Other), Icahn School of Medicine at Mount Sinai (Other)

129

Enrollment

Locations

85.2

Actual Duration (Months)

25.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

129 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program

Actual Study Start Date :

Aug 25, 2014

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Outcome Measures

Primary Outcome Measures

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
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)
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

Secondary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Northwestern University, Bluhm Cardiovascular Institute	Chicago	Illinois	United States	60611
3	The University of Kansas Medical Center Research Institute	Kansas City	Kansas	United States	66160
4	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
5	Columbia University Medical Center/Vivian and Seymour Milstein Family Heart Center	New York	New York	United States	10032