Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
6. september 2013 oppdatert av: Health Quality Partners
Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established.
This study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population.
The results reflect the impact of one of the study sites (Health Quality Partners) selected by the Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated Care Demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults.
The study began in April 2002.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
The community-based nursing care management model developed by Health Quality Partners represents a comprehensive set of integrated preventive and monitoring services designed for older adults living with chronic diseases.
The individual programs and services integrated within the model were selected on the basis of previously demonstrated evidence of effectiveness.
The model is delivered in the communities in which participants reside.
Care is delivered through in person contacts, (1 to 1 and group) as well as by telephone.
In person contacts occur in the home, in readily accessible community and faith-based organizations, health facilities, or the offices of Health Quality Partners.
Efforts are made to contact participants in the intervention group at least monthly with care continued until death, voluntary disenrollment, mandatory disenrollment due to changes in insurance coverage, relocation out of the service area, or change in long term level of care (e.g., nursing home placement, hospice).
Studietype
Intervensjonell
Registrering (Forventet)
2000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Doylestown, Pennsylvania, Forente stater, 18902
- Health Quality Partners
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Aged 65 years and older
- Medicare Part A and B traditional, fee for service insurance coverage
- One or more of the following chronic conditions:
- Heart failure
- Coronary Disease
- Diabetes mellitus
- Asthma
- Hypertension
- Hypercholesterolemia
- A Geriatric Risk Stratification Level of 2 or more based on a pre-enrollment screening tool
- Geriatric Risk Stratification Level changed in Sep 2006 to a Level of 3 or more
- Willingness of the participant's primary care provider to collaborate
Exclusion Criteria:
- Amyotrophic lateral sclerosis
- Alzheimer's disease
- Dementia
- Diagnosis or history of cancer (other than skin) in the past 5 years
- End-stage renal disease
- Life expectancy on enrollment less than 6 months
- HIV or AIDS
- Huntington's disease
- Organ transplant candidate
- Psychosis or schizophrenia
- Resident of or imminent plan for long-term nursing home placement
- Seasonal relocation outside of the area for more than 4 weeks per year
- Anyone receiving service from Health Quality Partners in the past
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Community-based nurse care management
Participants randomized to receive the intervention worked with a nurse care manager who provided them with a comprehensive set of geriatric and chronic disease preventive services.
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The community-based nurse care management program developed by Health Quality Partners uses nurses working in the community to provide the following integrated set of services to older adults with chronic illness over the long term in order to prevent avoidable complications of their diseases and aging; geriatric assessment, care coordination, health education, self-management coaching, weight management, physical activity, gait and balance training, medication adherence, care transition support, ongoing monitoring and symptom detection, collaborative problem solving with patients, families and health care providers.
Andre navn:
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Ingen inngripen: Usual care
Participants randomized to the control group received usual care without the involvement of a nurse care manager.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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All-cause mortality
Tidsramme: within 5 years of enrollment
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within 5 years of enrollment
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Blood pressure control
Tidsramme: within 5 years of enrollment
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within 5 years of enrollment
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Total cholesterol control
Tidsramme: within 5 years of enrollment
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within 5 years of enrollment
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Low density cholesterol control
Tidsramme: within 5 years of enrollment
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within 5 years of enrollment
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Triglycerides control
Tidsramme: within 5 years of enrollment
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within 5 years of enrollment
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Weight control
Tidsramme: within 5 years of enrollment
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within 5 years of enrollment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kenneth D Coburn, MD, MPH, Health Quality Partners
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Peikes D, Chen A, Schore J, Brown R. Effects of care coordination on hospitalization, quality of care, and health care expenditures among Medicare beneficiaries: 15 randomized trials. JAMA. 2009 Feb 11;301(6):603-18. doi: 10.1001/jama.2009.126.
- Brown R, Peikes D, Chen A, Schore J. 15-site randomized trial of coordinated care in Medicare FFS. Health Care Financ Rev. 2008 Fall;30(1):5-25.
- Bott DM, Kapp MC, Johnson LB, Magno LM. Disease management for chronically ill beneficiaries in traditional Medicare. Health Aff (Millwood). 2009 Jan-Feb;28(1):86-98. doi: 10.1377/hlthaff.28.1.86.
- Coburn KD, Marcantonio S, Lazansky R, Keller M, Davis N. Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial. PLoS Med. 2012;9(7):e1001265. doi: 10.1371/journal.pmed.1001265. Epub 2012 Jul 17.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2002
Primær fullføring (Forventet)
1. desember 2014
Studiet fullført (Forventet)
1. desember 2016
Datoer for studieregistrering
Først innsendt
16. desember 2009
Først innsendt som oppfylte QC-kriteriene
18. februar 2010
Først lagt ut (Anslag)
19. februar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. september 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2013
Sist bekreftet
1. september 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 95-C-91360/3-01
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