Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months
研究概览
简要总结
The purpose of this parallel pragmatic randomized controlled trial (RCT) is to evaluate the impact of Eat Well (an evidence-based 'Food is Medicine' produce prescription program) with varying levels of behavioral support on health outcomes and care utilization patterns of Duke Health patients diagnosed with congestive heart failure (CHF). Objectives of this three arm trial include testing the effectiveness of Eat Well alone with minimal behavioral support and Eat Well with intensified behavioral support based on an evidence based approach to improve CHF patients' health outcomes, estimating health care cost savings between the intervention and control arms, and identifying barriers, facilitators, and potential strategies to enhance Eat Well effectiveness and implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 or older
- •Diagnosis of CHF regardless of ejection fraction AND
- •Hospitalization or ED visit within the past 12 months AND
- •At risk of food insecurity as defined by one of the following:
- •screened positive for financial instability (medium risk and up) or food insecurity in the past 12 months minimum OR a Medicaid or dual eligible enrollee
- •English as preferred language
- •Valid email address (for virtual health coaching intervention)
- •NC mailing address
排除标准
- •History of dialysis or end stage renal disease OR
- •History of LVAD or heart transplant.
研究组 & 干预措施
Usual Care
Patients will continue to receive their usual care as well as educational materials
Prescription Produce program with low behavioral support
Patients will receive the Eat Well Prescription Produce benefit card ($100/month for 12 months) with low behavioral support provided by Reinvestment Partners
干预措施: Prescription Produce (Other)
Prescription Produce program with high behavioral support
Patients will receive the Eat Well Prescription produce benefit card ($100/month for 12 months) with high behavioral support provided by Reinvestment Partners and ZealCare
干预措施: Personal health planning and nutritional coaching (Behavioral)
Prescription Produce program with high behavioral support
Patients will receive the Eat Well Prescription produce benefit card ($100/month for 12 months) with high behavioral support provided by Reinvestment Partners and ZealCare
干预措施: Prescription Produce (Other)
结局指标
主要结局
Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months
时间窗: 12 months
The primary outcome of interest will be a composite endpoint of: ED visits, hospitalizations, and all-cause mortality at 12 months.
次要结局
- Outpatient utilization(12 months)
- Change in Blood pressure(12 months)
- Change in Body Mass Index(12 months)
- Heart Failure Specific Hospitalization(12 months)
- Heart Failure specific Emergency Department use(12 months)
- All cause ED visits(12 months)
- All cause hospitalizations(12 months)
- Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12)(Baseline, 6 months, and 12 months)
- USDA 6-item Food Security Survey Module (FSSM)(Baseline, 6 months, and 12 months)
- Dietary Screener Questionnaire (DSQ)(Baseline, 6 months, and 12 months.)
- Outpatient utilization(12 months)
- All cause hospitalizations(12 months)
- All cause ED visits(12 months)
- Change in Blood pressure(12 months)
- Change in Body Mass Index(12 months)
- Heart Failure Specific Hospitalization(12 months)
- Heart Failure specific Emergency Department use(12 months)
- Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12)(Baseline, 6 months, and 12 months)
- USDA 6-item Food Security Survey Module (FSSM)(Baseline, 6 months, and 12 months)
- Dietary Screener Questionnaire (DSQ)(Baseline, 6 months, and 12 months.)