Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
6 september 2013 uppdaterad 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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Förväntat)
2000
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Doylestown, Pennsylvania, Förenta staterna, 18902
- Health Quality Partners
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Inget ingripande: Usual care
Participants randomized to the control group received usual care without the involvement of a nurse care manager.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
All-cause mortality
Tidsram: within 5 years of enrollment
|
within 5 years of enrollment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Blood pressure control
Tidsram: within 5 years of enrollment
|
within 5 years of enrollment
|
|
Total cholesterol control
Tidsram: within 5 years of enrollment
|
within 5 years of enrollment
|
|
Low density cholesterol control
Tidsram: within 5 years of enrollment
|
within 5 years of enrollment
|
|
Triglycerides control
Tidsram: within 5 years of enrollment
|
within 5 years of enrollment
|
|
Weight control
Tidsram: within 5 years of enrollment
|
within 5 years of enrollment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kenneth D Coburn, MD, MPH, Health Quality Partners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2002
Primärt slutförande (Förväntat)
1 december 2014
Avslutad studie (Förväntat)
1 december 2016
Studieregistreringsdatum
Först inskickad
16 december 2009
Först inskickad som uppfyllde QC-kriterierna
18 februari 2010
Första postat (Uppskatta)
19 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 september 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 september 2013
Senast verifierad
1 september 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 95-C-91360/3-01
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .