Clinical trial NCT01321853: Home Care Medication Management Program for the Frail Elderly
Official title: Home Care Medication Management Program for the Frail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Illness
Cognitive Impairment
Keywords: Home health care
Medication Management
Cognitive impairment
Medication adherence
Older adults
Care Coordination management
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
name: National Institute of Nursing Research (NINR)
First posted: 2011-03-24
Enrollment: 414
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Geriatric Depression Scale
timeFrame: 12 months
measure: Physical Performance Test (PPT)
timeFrame: 12 months
measure: SF-36 Health Survey
timeFrame: 12 months
measure: Mental Mental Status Exam (MMSE)
timeFrame: 12 months
measure: Hospitalization
timeFrame: 12 month enrollment period
measure: Hospital Days
timeFrame: 12 Month Enrollment Period
measure: Emergency Department Visits
timeFrame: 12 month Enrollment Period
measure: Medicare Costs
timeFrame: 12 Month Enrollment Period
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: Arizona State University
name: Karen S Marek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.