Home Care Medication Management Program for the Frail Elderly

This study has been completed.
Sponsor:
Collaborators:
University of Wisconsin, Milwaukee
Information provided by (Responsible Party):
Arizona State University
ClinicalTrials.gov Identifier:
NCT01321853
First received: March 15, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Chronic Illness
Cognitive Impairment
Other: MD2 machine and nurse care coordination
Other: Medplanner and Nurse Care Coordination
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Home Care Medication Management Program for the Frail Elderly

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Geriatric Depression Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The Geriatric Depression Scale (GDS) was developed to identify depression in older adults. The original GDS was 30 questions, however, fifteen- and five-question versions also exist. When tested on the oldest old in the community, the 15-item scale was demonstrated to have favorable reliability and validity results. Impaired cognitive function (MMSE < 28) reduced the tool's specificity, but sensitivity was not affected by lower MMSE scores. The tool is scored into depression categories of "none/mild", "moderate" and "major".

  • Physical Performance Test (PPT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This functional status test has demonstrated reliability and validity, is easy to administer, can be performed in a reasonable period of time, and imposes little burden on the individual being tested. Even men and women with mild to moderate dementia are capable of understanding the test and performing activities reliably. There are 7 items on the test that range in difficulty from very easy to perform (writing a sentence) to challenging (picking up a penny), thus encompassing a spectrum of physical capabilities.

  • SF-36 Health Survey [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This tool is a widely used generic health status questionnaire measuring eight dimensions of health status: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. In addition, the SF-36 can be transformed into a Health State Utility Index that allows for health improvements to be stated in terms of quality adjusted life years (QALYs) gained.

  • Mental Mental Status Exam (MMSE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This 11-item measure screens for cognitive abilities in the domains of orientation, memory, attention, recall, language and visual/spatial orientation. The MMSE may be a categorical or continuous-level variable. When used as a categorical variable, the MMSE is broken down into 4 levels: (a) score range 24-30 is considered within normal limits (WNL), (b) score range of 18-23 is considered mild cognitive impairment, (c) score range of 12-17 is considered moderate cognitive impairment, and (d) a score range of 11 or less is considered to be severe cognitive impairment.

  • Hospitalization [ Time Frame: 12 month enrollment period ] [ Designated as safety issue: No ]
    Medicare claims data will be the source of information for this measure.

  • Hospital Days [ Time Frame: 12 Month Enrollment Period ] [ Designated as safety issue: No ]
    Medicare claims data will be the source of information for this measure.

  • Emergency Department Visits [ Time Frame: 12 month Enrollment Period ] [ Designated as safety issue: No ]
    Medicare claims data will be the source of information for this measure.

  • Medicare Costs [ Time Frame: 12 Month Enrollment Period ] [ Designated as safety issue: No ]
    Medicare claims data will be the source of information for this measure.


Enrollment: 414
Study Start Date: May 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: Medplanner and NCC
Medications loaded in medplanner by nurse care coordinator who coordinates care among providers and visits subject at least every 2 weeks
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.
No Intervention: Usual Care Group
Admitted post home health care with no intervention.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321853

Locations
United States, Wisconsin
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Arizona State University
University of Wisconsin, Milwaukee
Investigators
Principal Investigator: Karen S Marek, PhD Arizona State University
  More Information

No publications provided by Arizona State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT01321853     History of Changes
Other Study ID Numbers: 144PG09, 5R01NR008911
Study First Received: March 15, 2011
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Arizona State University:
Home health care
Medication Management
Cognitive impairment
Medication adherence
Older adults
Care Coordination management

Additional relevant MeSH terms:
Chronic Disease
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Disease Attributes
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014