Reduction in Hospitalizations in Low-Income Patients With Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Total number of all cause hospitalization days
研究概览
简要总结
The purpose of this study is to test whether a culturally sensitive self-management (SM) intervention, compared to an education only control, will reduce all-cause hospital days in patients with mild to moderate heart failure and household income less than $30,000 per year.
详细描述
The purpose of the CHART research study is to assess the value of a novel multi-level intervention for low-income patients recently hospitalized with heart failure relative to providing education alone (both strategies are described in detail in the Intervention section below). The investigators refer to their novel intervention strategy as 'Enhanced Training' and their education-only strategy the investigators refer to as 'Enhanced Education'. These two strategies of participant follow-up will be assessed and compared by analyzing patient's all-cause hospital days over a 2.5-year follow-up period (the investigators note that, for patients with heart failure, the average number of such all-cause hospital days over a 2.5-year period has tripled over the past 25 years). The Enhanced Training strategy aims to improve patient receipt of evidence-based therapy by: 1) activating patients using a culturally sensitive approach that might better resonate with the investigators predominantly urban, African-American and Hispanic, target population; 2) providing timely and useful information to the primary care provider; and 3) promoting effective communication between patients and their primary care provider. The Enhanced Education strategy is less intrusive and aims to provide patients and primary care providers with appropriate educational materials via mail. The primary aims of this research study are to determine if Enhanced Training and/or Enhanced Education will improve: patient adherence to drug therapy and salt restriction, health care provider adherence to evidence-based guidelines, and patient functional capacity and quality of life. Secondary aims will include assessing impact of the interventions on CRP and BNP, which are two key biomarkers of heart failure progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Inclusion Criteria (PCP)
- •Provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s).
- •Inclusion Criteria (Patients)
- •Participant has been diagnosed with Heart Failure (HF),
- •Self reported family income is less than $30,000/year,
- •Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon:
- •Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and
- •responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers.
- •Has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year.
- •Age ≥ 18 years
- •Currently resides in Cook County, Illinois.
- •Speaks English or Spanish.
- •The primary care provider (PCP) has consented and has no more than 12 patients enrolled.
- •Completed the informed consent process.
- •Successfully completed the 30-day run-in period and study baseline visit
排除标准
- •Exclusion Criteria (PCP)
- •Health providers will be excluded from enrollment if they are:
- •Still in their residency or training period,
- •A member of the CHART research staff.
- •Exclusion Criteria (Patients)
- •Patients will be excluded from enrollment if they have:
- •An uncertain 12-month prognosis.
- •Listed for imminent cardiac transplant.
- •Has an advanced directive of "Do not resuscitate".
- •Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator
结局指标
主要结局
Total number of all cause hospitalization days
时间窗: Measured over the 30 month patient participant follow-up period
Participant's are queried quarterly concerning any hospitalizations occuring since the previous contact. These self-reported events are then confirmed via study adjudication of pertinent acquired hospital medical records. Analysis of the primary outcome will consist of comparing mean total number of all-cause hospitalization days between the two intervention groups. Analyses will also be performed with respect to the following pre-determined subgroups: (Primary Healthcare Provider subgroups) medical specialty, academic rank, "adherent" to evidence-based guidelines at baseline, and number of years since certification; (Patient Participant subgroups) age, gender, ethnicity, insurance status, years of education, health literacy, number of comorbidities, medication adherence at baseline, heart failure functional capacity, baseline BNP, presence of major stress and/or psychological trauma, perceived social support, number of years since first heart failure diagnosis, and self-efficacy
次要结局
- The Kansas City Cardiomyopathy Questionnaire(This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Total number of heart failure related hospitalization days(measured over the 30 month patient participant follow-up period)
- Health Care Costs(Measured over the 30 monthstudy follow-up period)
- CALS Food Frequency Questionnaire (Salt Intake)(This questionnaire is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Self-Efficacy of Heart Failure Self-Management(This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Biomarkers of heart failure progression(Assessed during in-person participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Traumatic Stress Survey (Composite International Diagnostic Interview)(This survey that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Distance traveled during th Six-Minute Walk test(This test is administered during in-person participant assessment visits conducted at baseline and at 6 and 30 months following treatment assignmentMeasured over/after 30 months)
- PCL-Civilian Short Form(This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Patient Medication Adherence(Adherence is measured at baseline and at 6 and 30 months following treatment assignment)
- PCP Adherence to blood pressure goal(Patient participant blood pressure is assessed during in-person participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- EQ-5D Visual Analog Scale (VAS) with Time Trade-Off (TTO) Utility Score(This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Modified Global Adherence Indicator (mGAI3)(This is assessed at baseline and at 6 and 30 months following participant treatment assignment.)
- Total number of heart failure hospitalizations and emergency room visits.(Measured over the 30 month patient participant follow-up period.)
- PHQ9 (Depression)(This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
- Past Stressor Events(This is a questionnaire that is administered during participant assessments conducted at baseline and at 6 and 30 months following treatment assignment.)
研究者
Lynda Powell, PhD, MEd
Principal Investigator
Rush University Medical Center