Kaiser Permanente Evaluation of Medically-Tailored Meals in Adults With Chronic Medical Conditions at High Readmission Risk (KP NOURISH) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- 90-day hospitalization for any cause
研究概览
简要总结
This study is a virtual, remote, decentralized pragmatic clinical trial comparing the efficacy of medically tailored meals alone or medically tailored meals with remote nutritional counseling compared with usual standard of care in adults with a targeted, nutrition-sensitive chronic medical condition (heart failure, diabetes mellitus, chronic kidney disease).
详细描述
For the KP NOURISH Study, eligible members hospitalized within participating Kaiser Permanente Northern California medical centers will be identified and screened electronically and pre-randomized to 1 of 3 arms (medically tailored meals alone vs. medically tailored meals with remotely delivered enhanced nutritional counseling sessions vs. usual care). Patients enrolled in the medically tailored meals arm will receive 1 medically-tailored meal per day for 10 weeks after hospital discharge. Patients enrolled in the medically tailored meals with enhanced nutritional counseling arm will receive 1 medically-tailored meal per day for 10 weeks after discharge with up to 3 remotely delivered nutritional counseling sessions with a registered dietician nutritionist during the same time period. Patients enrolled in the usual care arm will continue to receive their typical standard of care management. All enrolled patients will complete a questionnaire for patient-reported outcomes (i.e., self-efficacy, social isolation, patient satisfaction, and caring science domains) at baseline and at 10 weeks after discharge and followed electronically for total resource utilization and 30-, 60-, and 90-day outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Hospitalized at Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
- •Kaiser Permanente member at admission
- •Has a prior history of at least one of the following:
- •Heart failure
- •Diabetes mellitus
- •Chronic kidney disease
排除标准
- •Receiving primary care at Kaiser Permanente facilities outside of Kaiser Permanente Santa Rosa, Santa Clara, San Francisco, Oakland, or San Rafael Medical Centers
- •Language interpreter needed
- •Admitted from skilled nursing facility or nursing home
- •Homeless at admission
- •Residence outside the geographic area covered by the medically tailored meals vendors
- •Prior history of organ transplant
结局指标
主要结局
90-day hospitalization for any cause
时间窗: 90-days after discharge from the index hospitalization
Occurrence of an acute hospitalization for any reasons within 90-days after discharge from the index hospitalization.
次要结局
- Emergency department visit for any cause(30-, 60- and 90-days after discharge from the index hospitalization)
- 30-day hospitalization for any cause(30-days after discharge from the index hospitalization)
- Patient-reported outcomes(10 weeks after discharge from the index hospitalization)
- 90-day hospitalization related to heart failure(90-days after discharge from the index hospitalization)
- 90-day hospitalization related to diabetes(90-days after discharge from the index hospitalization)
- 90-day all-cause mortality(90-days after discharge from the index hospitalization)
- 90-day composite of hospitalization for any cause, emergency department visit for any cause or all-cause death(90-days after discharge from the index hospitalization)
- 60-day hospitalization for any cause(60-days after discharge from the index hospitalization)