NCT01321853

Home Care Medication Management Program for the Frail Elderly

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Illness
• Cognitive Impairment

Interventions

Type	Name	Description
OTHER	MD2 machine and nurse care coordination	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.
OTHER	Medplanner and Nurse Care Coordination	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.

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2011-03-24
• Last updated: 2012-01-06

Locations

1 site across 1 country: United States