VALOR (Veterans Affairs Lowering Readmissions) in Heart Failure Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Heart Failure Specific Quality of Life
研究概览
简要总结
Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the most common indication for readmission in older adults and the most frequent reason for 30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy to lower HF recurrence. However, adherence to medications and dietary recommendations is low in HF patients. Nonadherence is often due to an interaction among the environment, the patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality improvement program (QIP) to improve HF care using a pretest-posttest design. This interdisciplinary theory-based prospective experimental study will target improving HF treatment using patient-based behavioral and checklist intervention, as well as provider and system-targeted checklists and treatment defaults (posttest or intervention phase); this will be compared to current best practice (CBP) evaluated in the pretest (pretest or pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient, provider and system levels, will improve QOL and lower HF recurrence compared to CBP.
详细描述
Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the most common indication for readmission in older adults and the most frequent reason for 30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy to lower HF recurrence. However, adherence to medications and dietary recommendations is low in HF patients. Nonadherence is often due to an interaction among the environment, the patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality improvement program (QIP) to improve HF care using a pretest-posttest design. This interdisciplinary theory-based prospective experimental study will target improving HF treatment using patient-based behavioral and checklist intervention, as well as provider and system-targeted checklists and treatment defaults (posttest or intervention phase); this will be compared to current best practice (CBP) evaluated in the pretest (pretest or pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient, provider and system levels, will improve QOL and lower HF recurrence compared to CBP.
The primary specific aims are 1) To test the effect of QIP on HF-specific quality of life compared to the CBP group, and 2) To evaluate the impact of QIP group on general quality of life compared to the CBP group.
Secondary specific aims are to:
- assess the effect of QIP on medication adherence at 3 months, 2) examine the effect of QIP on diet adherence at 3 months, and 3) evaluate the effect of QIP on satisfaction, and 4) assess the effect of QIP on intervention acceptability. We will also examine the impact of QIP at 3 months on keeping routine outpatient visits, health-care utilization, exercise capacity, weight, perceived stress, depression, cardiovascular events and deaths.
Exploratory aim is to examine the effect of the QIP on 30 day post-discharge HF readmission rates compared to CBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted with either systolic or diastolic HF will be identified through ongoing daily prospective manual search of admission records in VA NYHHS
- •Men and women ( 21 years) being discharged after a HF admission will be eligible
- •They must have an available phone
排除标准
- •Patients with poor short-term survival (< 3 months)
- •recent major surgery (< 1 month)
- •planned discharge to a long-term-care facility
- •severe dementia or other serious psychiatric illness
- •temporarily in the area
- •those unable to provide consent, refusal to participate
- •logistic or discretionary reasons (including participation in another study) will be excluded
研究组 & 干预措施
Current Best Practice (CBP)
CBP received no intervention and only current best practices for inpatient HF care.
Quality improvement program (QIP)
Comprehensive quality improvement program (QIP) intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
干预措施: Comprehensive quality improvement program (QIP) (Behavioral)
结局指标
主要结局
Heart Failure Specific Quality of Life
时间窗: 3 months after discharge
Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.
General Quality of Life From the Standardized Physical Component Score
时间窗: 3 months after discharge
Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
次要结局
- Role Physical(3 months after discharge)
- General Health(3 months after discharge)
- Emotional Subscale of Heart Failure Specific Quality of Life(3 months after discharge)
- Physical Functioning(3 months after discharge)
- Standardized Mental Component Score(3 months after discharge)
- Role Emotional(3 months after discharge)
- Mental Health(3 months after discharge)
- Vitality(3 months after discharge)
- Physical Subscale of Heart Failure Specific Quality of Life(3 months after discharge)
- Pain Index(3 months after discharge)
- Social Functioning(3 months after discharge)