Study of Impact of Home Biomonitoring With Nurse Case Manager Support for a Congestive Heart Failure Cohort, Compared to Case Manager Support Without Biomonitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 2
- 主要终点
- Time to acute hospital admission
研究概览
简要总结
The hypothesis is that use of Internet-connected home biomonitoring of weight, blood pressure and other indicators, in conjunction with nurse case management, will result in improved outcome for Medicare beneficiaries with with Congestive Heart Failure; compared to case management assistance without the biomonitoring device.
详细描述
Goals of the Study:
- Demonstrate synergy between the Intel® Health Guide home biomonitoring and nurse case management. Measure positive impact on member engagement and clinical outcomes for members with Heart Failure.
- Quantify the potential to avoid costly re-hospitalization based on the Intel® Health Guide - enhanced case management interaction through early alerts and early intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aetna Medicare (PFFS, HMO/PPO fully insured) Individual members, plus Medicare members from any plan sponsor that has agreed it would like its members to be included
- •Member meets Aetna Health Profile Database criteria for Chronic Heart Failure (Disease Management Eligibility = Y) with a disease risk stratification score of 3 - 5 (moderately severe to severe). These proprietary criteria yield a group of individuals for whom historical claims data estimates a substantial risk of hospital readmission within the coming 6 months.
- •Acute inpatient admission or 2 or more emergency room visits within 6 months prior to identification
- •Residence in the designated geographic areas selected for the study (The planned source population is all New Jersey, New York, Pennsylvania and North Central Aetna Individual Medicare members and North Central. If members identified from these states have not filled the study within three months, the source population may be expanded to include Aetna's North Central region members in Illinois and Ohio. These North Central members would include all Aetna Medicare Individual members in these areas, plus any Group Medicare members from Groups whose Plan Sponsors agree that the study may be offered to the members.)
- •Member may be currently open/ active in case management
- •Responds telephonic outreach to offer study participation, or to Interactive Voice Response outreach call, and confirms each of:
- •Their own identity {secure Health Insurance Portability Accountability Act (HIPAA) compliant acknowledgement to caller}
- •That they have been told of having a heart condition
- •Interest in hearing more and possibly participating in the study
排除标准
- •Member had case management and this was closed within the 30 days prior to identification for the study
- •End-of life, terminal cancer, end stage renal disease, hospice, late stage Alzheimer's disease, dementia, ventricular assist device, heart transplant or active in heart transplant program. Excluded diagnoses or conditions will be identified where it is evident through Aetna's Health Profile Data diagnoses in claims, or upon case management assessment.
- •Chronic or ongoing intravenous heart failure medication
- •Any response to Interactive Voice Response outreach call other than "Yes, I am interested"
结局指标
主要结局
Time to acute hospital admission
时间窗: 6 months
During the 6 month intervention period, it is expected that the time from entering the study until the first primary event (acute hospital admission, emergency room visit or death) will be, on average, longer for those using the Intel® Health Guide with case management (HG-CM) than for those in the routine case management (Case Management-Only Group). The primary measure to be compared across the study groups will be the unadjusted hazard ratio.
Acute Hospital Admission, Emergency Room Visit or Death
时间窗: 6 months
It is expected that the proportion of members with an inpatient acute admission, emergency room visit, or death in the intervention period and follow-up periods will be lower in the HG-CM Group than the Case Management-Only Group.
次要结局
- Decrease the number of acute hospital admissions and emergency room visits(6 months)
- Number of Inpatient Hospital Days associated with Acute Admissions(6 months)
- Cardiovascular Admissions Decreased(6 months)