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Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults

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ClinicalTrials.gov Identifier: NCT01071967
Recruitment Status : Unknown
Verified September 2013 by Health Quality Partners.
Recruitment status was:  Enrolling by invitation
First Posted : February 19, 2010
Last Update Posted : September 10, 2013
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Health Quality Partners

Tracking Information
First Submitted Date  ICMJE December 16, 2009
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE April 2002
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
All-cause mortality [ Time Frame: within 5 years of enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • Blood pressure control [ Time Frame: within 5 years of enrollment ]
  • Total cholesterol control [ Time Frame: within 5 years of enrollment ]
  • Low density cholesterol control [ Time Frame: within 5 years of enrollment ]
  • Triglycerides control [ Time Frame: within 5 years of enrollment ]
  • Weight control [ Time Frame: within 5 years of enrollment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Official Title  ICMJE Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Heart Failure
  • Coronary Disease
  • Diabetes Mellitus
  • Asthma
  • Hypertension
  • Hypercholesterolemia
Intervention  ICMJE Other: Community-based nurse care management
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.
Other Names:
  • Health Quality Partners
  • Medicare Coordinated Care Demonstration
  • Care Coordination
  • Disease Management
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: Community-based nurse care management
  • No Intervention: Usual care
    Participants randomized to the control group received usual care without the involvement of a nurse care manager.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 18, 2010)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071967
Other Study ID Numbers  ICMJE 95-C-91360/3-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Health Quality Partners
Study Sponsor  ICMJE Health Quality Partners
Collaborators  ICMJE Centers for Medicare and Medicaid Services
Investigators  ICMJE
Principal Investigator: Kenneth D Coburn, MD, MPH Health Quality Partners
PRS Account Health Quality Partners
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP