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

Primary Purpose

Heart Failure, Coronary Disease, Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-based nurse care management
Sponsored by
Health Quality Partners
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Community Health Nursing, Nursing Care Management, Aged, Aged, 80 and over, Health Services for the Aged, Geriatric Nursing, Geriatric Assessment, Longevity, Mortality

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health Quality Partners

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community-based nurse care management

Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

Blood pressure control
Total cholesterol control
Low density cholesterol control
Triglycerides control
Weight control

Full Information

First Posted
December 16, 2009
Last Updated
September 6, 2013
Sponsor
Health Quality Partners
Collaborators
Centers for Medicare and Medicaid Services
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1. Study Identification

Unique Protocol Identification Number
NCT01071967
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Quality Partners
Collaborators
Centers for Medicare and Medicaid Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Community-based nurse care management
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants randomized to the control group received usual care without the involvement of a nurse care manager.
Intervention Type
Other
Intervention Name(s)
Community-based nurse care management
Other Intervention Name(s)
Health Quality Partners, Medicare Coordinated Care Demonstration, Care Coordination, Disease Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
within 5 years of enrollment
Secondary Outcome Measure Information:
Title
Blood pressure control
Time Frame
within 5 years of enrollment
Title
Total cholesterol control
Time Frame
within 5 years of enrollment
Title
Low density cholesterol control
Time Frame
within 5 years of enrollment
Title
Triglycerides control
Time Frame
within 5 years of enrollment
Title
Weight control
Time Frame
within 5 years of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth D Coburn, MD, MPH
Organizational Affiliation
Health Quality Partners
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Quality Partners
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19211468
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.
Results Reference
background
PubMed Identifier
19040171
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.
Results Reference
background
PubMed Identifier
19124858
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.
Results Reference
background
PubMed Identifier
22815653
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.
Results Reference
derived
Links:
URL
http://www.hqp.org
Description
Health Quality Partners
URL
http://www.clinicaltrials.gov/ct2/show/NCT00627029?term=Medicare+Coordinated+Care+Demonstration&rank=1
Description
Related ClinicalTrials.gov study

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

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