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Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Health Quality Partners.
Recruitment status was: Enrolling by invitation
Recruitment status was: Enrolling by invitation
Sponsor:
Health Quality Partners
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
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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: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Effect of a Longitudinal, Multifactorial Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults |
Further study details as provided by Health Quality Partners:
Primary Outcome Measures:
- All-cause mortality [ Time Frame: within 5 years of enrollment ]
Secondary Outcome Measures:
- Blood pressure control [ Time Frame: within 5 years of enrollment ]
- Total cholesterol control [ Time Frame: within 5 years of enrollment ]
- Low density cholesterol control [ Time Frame: within 5 years of enrollment ]
- Triglycerides control [ Time Frame: within 5 years of enrollment ]
- Weight control [ Time Frame: within 5 years of enrollment ]
| 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:
|
|
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) |
| 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
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
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:
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 |
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 August 17, 2017