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

NCT ID: NCT01071967

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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).

Conditions

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Heart Failure Coronary Disease Diabetes Mellitus Asthma Hypertension Hypercholesterolemia

Keywords

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Community Health Nursing Nursing Care Management Aged Aged, 80 and over Health Services for the Aged Geriatric Nursing Geriatric Assessment Longevity Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Community-based nurse care management

Intervention Type OTHER

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.

Usual care

Participants randomized to the control group received usual care without the involvement of a nurse care manager.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Health Quality Partners Medicare Coordinated Care Demonstration Care Coordination Disease Management

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Medicare and Medicaid Services

FED

Sponsor Role collaborator

Health Quality Partners

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth D Coburn, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Health Quality Partners

Locations

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Health Quality Partners

Doylestown, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19211468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19040171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19124858 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22815653 (View on PubMed)

Related Links

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http://www.hqp.org

Health Quality Partners

http://www.clinicaltrials.gov/ct2/show/NCT00627029?term=Medicare+Coordinated+Care+Demonstration&rank=1

Related ClinicalTrials.gov study

Other Identifiers

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95-C-91360/3-01

Identifier Type: -

Identifier Source: org_study_id