Home Care Medication Management Program for the Frail Elderly
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 2
- 主要终点
- Geriatric Depression Scale
研究概览
简要总结
The purpose of this study is to determine whether a home care medication management program which includes nurse coordination and use of the MD.2 medication-dispensing machine will affect older adults' health outcomes, satisfaction, use of health care services, and health care costs over a one year period. The investigators propose a longitudinal three group repeated measures design, enrolling, and randomly assigning, clients who are discharged from a home health care agency with documented problems in medication management. One group will receive the MD.2 medication dispensing device and nurse coordination, the second group will receive a Medplanner: a simple box that has separate compartments for individual medication times over the course of a week plus nurse coordination, and the final group will receive Usual Care.
The study hypotheses are the following:
H1: With respect to health status outcomes, the MD.2 group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Medplanner Group.
H2: With respect to health status outcomes, the Medplanner Group will exhibit a more positive trajectory in physical and mental health status, functional status, cognitive status and depressive symptoms over the course of a year than will the Usual Care Group.
H3: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H4: The rate of hospitalization, hospital days and emergency department visits will be significantly lower for the Medplanner Group as compared to the Usual Care Group.
H5: The nursing home admission rate will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H6: The nursing home admission rate will be significantly lower for the Medplanner Group as compared to the Usual Care Group.
H7: The total cost of care will be significantly lower for the MD.2 Group as compared to the Medplanner Group.
H8: The total cost of care will be significantly lower for the Medplanner Group as compared to The Usual Care Group.
H9: There will be incremental savings in terms of costs per quality adjusted life year (QALY) gained in the MD.2 group compared with the Medplanner Group.
H10: There will be incremental savings in terms of costs per QALY gained in the Medplanner group compared with the Usual Care Group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 and older
- •Medicare Primary Payer
- •Impaired Medication Management ability as indicated by a score of 1 or higher on OASIS discharge assessment item M0780
- •Impaired Cognitive Functioning but able to follow directions with prompting as indicated by a score of 1 or 2 on OASIS discharge assessment item M0560
- •working telephone line
- •Discharge from home health care
排除标准
- •Not English speaking
- •Terminal diagnosis or hospice care
- •Use of other device for medications
- •Medicare via managed care
- •Use of private home care agency for medication management
结局指标
主要结局
Geriatric Depression Scale
时间窗: 12 months
The Geriatric Depression Scale (GDS) was developed to identify depression in older adults. The original GDS was 30 questions, however, fifteen- and five-question versions also exist. When tested on the oldest old in the community, the 15-item scale was demonstrated to have favorable reliability and validity results. Impaired cognitive function (MMSE \< 28) reduced the tool's specificity, but sensitivity was not affected by lower MMSE scores. The tool is scored into depression categories of "none/mild", "moderate" and "major".
Physical Performance Test (PPT)
时间窗: 12 months
This functional status test has demonstrated reliability and validity, is easy to administer, can be performed in a reasonable period of time, and imposes little burden on the individual being tested. Even men and women with mild to moderate dementia are capable of understanding the test and performing activities reliably. There are 7 items on the test that range in difficulty from very easy to perform (writing a sentence) to challenging (picking up a penny), thus encompassing a spectrum of physical capabilities.
SF-36 Health Survey
时间窗: 12 months
This tool is a widely used generic health status questionnaire measuring eight dimensions of health status: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. In addition, the SF-36 can be transformed into a Health State Utility Index that allows for health improvements to be stated in terms of quality adjusted life years (QALYs) gained.
Mental Mental Status Exam (MMSE)
时间窗: 12 months
This 11-item measure screens for cognitive abilities in the domains of orientation, memory, attention, recall, language and visual/spatial orientation. The MMSE may be a categorical or continuous-level variable. When used as a categorical variable, the MMSE is broken down into 4 levels: (a) score range 24-30 is considered within normal limits (WNL), (b) score range of 18-23 is considered mild cognitive impairment, (c) score range of 12-17 is considered moderate cognitive impairment, and (d) a score range of 11 or less is considered to be severe cognitive impairment.
Hospitalization
时间窗: 12 month enrollment period
Medicare claims data will be the source of information for this measure.
Hospital Days
时间窗: 12 Month Enrollment Period
Medicare claims data will be the source of information for this measure.
Emergency Department Visits
时间窗: 12 month Enrollment Period
Medicare claims data will be the source of information for this measure.
Medicare Costs
时间窗: 12 Month Enrollment Period
Medicare claims data will be the source of information for this measure.
次要结局
未报告次要终点