Inotrope, Evaluation and Research (INTERPRET) Patient Registry Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 5
- 主要终点
- Mean time of survival post-treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean time of survival post-treatment
时间窗: 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
Quality of life assessment: Questionnaire
时间窗: 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
Number of re-hospitalizations
时间窗: Through study completion, on average 6 months
Recorded on the Pharmacy Clinical Progress Report
Duration of re-hospitalizations
时间窗: Through study completion, on average 6 months
The duration (days) of re-hospitalization visits
Primary cause of re-hospitalization visits
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Concomitant medication use(Weekly, through study completion (an average of 6 months))
- Additional patient symptoms(Weekly, through study completion (an average of 6 months))