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Home Care Medication Management Program for the Frail Elderly

4. januar 2012 opdateret af: Arizona State University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

414

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53201
        • University of Wisconsin-Milwaukee

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Eksperimentel: Medplanner and NCC
Medications loaded in medplanner by nurse care coordinator who coordinates care among providers and visits subject at least every 2 weeks
Andet: 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.
Ingen indgriben: Usual Care Group
Admitted post home health care with no intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geriatric Depression Scale
Tidsramme: 12 months
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".
12 months
Physical Performance Test (PPT)
Tidsramme: 12 months
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.
12 months
SF-36 Health Survey
Tidsramme: 12 months
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.
12 months
Mental Mental Status Exam (MMSE)
Tidsramme: 12 months
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.
12 months
Hospitalization
Tidsramme: 12 month enrollment period
Medicare claims data will be the source of information for this measure.
12 month enrollment period
Hospital Days
Tidsramme: 12 Month Enrollment Period
Medicare claims data will be the source of information for this measure.
12 Month Enrollment Period
Emergency Department Visits
Tidsramme: 12 month Enrollment Period
Medicare claims data will be the source of information for this measure.
12 month Enrollment Period
Medicare Costs
Tidsramme: 12 Month Enrollment Period
Medicare claims data will be the source of information for this measure.
12 Month Enrollment Period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arizona State University

Samarbejdspartnere

National Institute of Nursing Research (NINR)
University of Wisconsin, Milwaukee

Efterforskere

  • Ledende efterforsker: Karen S Marek, PhD, Arizona State University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. maj 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

15. marts 2011

Først indsendt, der opfyldte QC-kriterier

22. marts 2011

Først opslået (Skøn)

24. marts 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 144PG09
  • 5R01NR008911 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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