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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Health Quality Partners
ClinicalTrials.gov Identifier:
NCT01071967
First received: December 16, 2009
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Heart Failure
Coronary Disease
Diabetes Mellitus
Asthma
Hypertension
Hypercholesterolemia
Other: Community-based nurse care management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults

Resource links provided by NLM:


Further study details as provided by Health Quality Partners:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: within 5 years of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure control [ Time Frame: within 5 years of enrollment ] [ Designated as safety issue: No ]
  • Total cholesterol control [ Time Frame: within 5 years of enrollment ] [ Designated as safety issue: No ]
  • Low density cholesterol control [ Time Frame: within 5 years of enrollment ] [ Designated as safety issue: No ]
  • Triglycerides control [ Time Frame: within 5 years of enrollment ] [ Designated as safety issue: No ]
  • Weight control [ Time Frame: within 5 years of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2002
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Usual care
Participants randomized to the control group received usual care without the involvement of a nurse care manager.

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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01071967

Locations
United States, Pennsylvania
Health Quality Partners
Doylestown, Pennsylvania, United States, 18902
Sponsors and Collaborators
Health Quality Partners
Centers for Medicare and Medicaid Services
Investigators
Principal Investigator: Kenneth D Coburn, MD, MPH Health Quality Partners
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Health Quality Partners
ClinicalTrials.gov Identifier: NCT01071967     History of Changes
Other Study ID Numbers: 95-C-91360/3-01
Study First Received: December 16, 2009
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Health Quality Partners:
Community Health Nursing
Nursing Care Management
Aged
Aged, 80 and over
Health Services for the Aged
Geriatric Nursing
Geriatric Assessment
Longevity
Mortality

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Heart Failure
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014