Home Care Medication Management Program for the Frail Elderly

Completed · Phase 1

Conditions studied: Chronic Illness, Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT01321853

Run by

Arizona State University

People needed

414

Starts

2006-05-01

Expected to finish

2010-05-01

Last updated by the study team

2012-01-06

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Wisconsin-Milwaukee — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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