Home Care Medication Management Program for the Frail Elderly

NCT ID: NCT01321853

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MD2 machine and nurse care coordination

Intervention Type: OTHER

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.

Medplanner and NCC

Medications loaded in medplanner by nurse care coordinator who coordinates care among providers and visits subject at least every 2 weeks

Group Type: EXPERIMENTAL

Medplanner and Nurse Care Coordination

Intervention Type: OTHER

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.

Usual Care Group

Admitted post home health care with no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen S Marek, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

References

Marek KD, Stetzer F, Ryan PA, Bub LD, Adams SJ, Schlidt A, Lancaster R, O'Brien AM. Nurse care coordination and technology effects on health status of frail older adults via enhanced self-management of medication: randomized clinical trial to test efficacy. Nurs Res. 2013 Jul-Aug;62(4):269-78. doi: 10.1097/NNR.0b013e318298aa55.

Reference Type: DERIVED

PMID: 23817284 (View on PubMed)

Other Identifiers

5R01NR008911

Identifier Type: NIH

Identifier Source: secondary_id

View Link

144PG09

Identifier Type: -

Identifier Source: org_study_id