Clinical trial NCT01071967: Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Official title: Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Coronary Disease
Diabetes Mellitus
Asthma
Hypertension
Hypercholesterolemia
Keywords: Community Health Nursing
Nursing Care Management
Aged
Aged, 80 and over
Health Services for the Aged
Geriatric Nursing
Geriatric Assessment
Longevity
Mortality
Lead sponsor: Health Quality Partners
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
First posted: 2010-02-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: All-cause mortality
timeFrame: within 5 years of enrollment
Secondary outcomes:
measure: Blood pressure control
timeFrame: within 5 years of enrollment
measure: Total cholesterol control
timeFrame: within 5 years of enrollment
measure: Low density cholesterol control
timeFrame: within 5 years of enrollment
measure: Triglycerides control
timeFrame: within 5 years of enrollment
measure: Weight control
timeFrame: within 5 years of enrollment
Other outcomes:
Locations:
city: Doylestown
country: United States
facility: Health Quality Partners
state: Pennsylvania
Study officials:
affiliation: Health Quality Partners
name: Kenneth D Coburn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.