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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01071967
• Other study ID #: 95-C-91360/3-01
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 16, 2009
• Last updated: September 6, 2013
• Start date: April 2002
• Est. completion date: December 2016

Study information

• Verified date: September 2013
• Source: Health Quality Partners
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Failure
• Hypercholesterolemia
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Health Quality Partners	Doylestown	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Health Quality Partners	Centers for Medicare and Medicaid Services

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		within 5 years of enrollment	No
Secondary	Blood pressure control		within 5 years of enrollment	No
Secondary	Total cholesterol control		within 5 years of enrollment	No
Secondary	Low density cholesterol control		within 5 years of enrollment	No
Secondary	Triglycerides control		within 5 years of enrollment	No
Secondary	Weight control		within 5 years of enrollment	No

External Links

•   Health Quality Partners
•   Medicare Coordinated Care Demonstration - CMS Innovation Center
•   Related ClinicalTrials.gov study