Cognitive Impairment Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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