Home Care Medication Management Program for the Frail Elderly
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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53201
- University of Wisconsin-Milwaukee
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Machine and NCC
Medications dispensed to subject via MD2 machine and nurse care coordination used to coordinate care among providers and fill machine at least every 2 weeks.
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MD2 machine filled at least every 2 weeks and subjects monitored for changes in condition.
Additional visits made as needed.
Care is coordinated with other providers such as the primary care physician and pharmacist.
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実験的：Medplanner and NCC
Medications loaded in medplanner by nurse care coordinator who coordinates care among providers and visits subject at least every 2 weeks
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Medications are dispensed via a medplanner filled by a nurse at least every 2 weeks and subjects monitored for changes in condition.
Additional visits made as needed.
Care is coordinated with other providers such as the primary care physician and pharmacist.
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介入なし：Usual Care Group
Admitted post home health care with no intervention.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Geriatric Depression Scale
時間枠：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".
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12 months
|
|
Physical Performance Test (PPT)
時間枠：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.
|
12 months
|
|
SF-36 Health Survey
時間枠：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.
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12 months
|
|
Mental Mental Status Exam (MMSE)
時間枠：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.
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12 months
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Hospitalization
時間枠：12 month enrollment period
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Medicare claims data will be the source of information for this measure.
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12 month enrollment period
|
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Hospital Days
時間枠：12 Month Enrollment Period
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Medicare claims data will be the source of information for this measure.
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12 Month Enrollment Period
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Emergency Department Visits
時間枠：12 month Enrollment Period
|
Medicare claims data will be the source of information for this measure.
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12 month Enrollment Period
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Medicare Costs
時間枠：12 Month Enrollment Period
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Medicare claims data will be the source of information for this measure.
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12 Month Enrollment Period
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Karen S Marek, PhD、Arizona State University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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