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

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:

MedlinePlus related topics: Cholesterol Medicare

U.S. FDA Resources

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.

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 (Adult, Senior)
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:

Health Quality Partners This link exits the ClinicalTrials.gov site

Medicare Coordinated Care Demonstration - CMS Innovation Center This link exits the ClinicalTrials.gov site

Related ClinicalTrials.gov study This link exits the ClinicalTrials.gov site

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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:


Diabetes Mellitus Heart Failure Hypercholesterolemia Coronary Disease Coronary Artery Disease Chronic Disease Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Heart Diseases	Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Myocardial Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Disease Attributes Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016