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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Coronary Disease; Diabetes Mellitus; Asthma; Hypertension; Hypercholesterolemia	Other: Community-based nurse care management	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Study Start Date :	April 2002
Estimated Primary Completion Date :	December 2014
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. All-cause mortality [ Time Frame: within 5 years of enrollment ]

Secondary Outcome Measures :

1. Blood pressure control [ Time Frame: within 5 years of enrollment ]
2. Total cholesterol control [ Time Frame: within 5 years of enrollment ]
3. Low density cholesterol control [ Time Frame: within 5 years of enrollment ]
4. Triglycerides control [ Time Frame: within 5 years of enrollment ]
5. Weight control [ Time Frame: within 5 years of enrollment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Health Quality Partners 

Medicare Coordinated Care Demonstration - CMS Innovation Center 

Related ClinicalTrials.gov study 

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
First Posted:	February 19, 2010
Last Update Posted:	September 10, 2013
Last Verified:	September 2013

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