Home Care Medication Management Program for the Frail Elderly
Status and phase
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Treatments
Study type
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Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
414 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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