NCT01071967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

12.7 years

First QC Date

December 16, 2009

Last Update Submit

September 6, 2013

Conditions

Keywords

Community Health NursingNursing Care ManagementAgedAged, 80 and overHealth Services for the AgedGeriatric NursingGeriatric AssessmentLongevityMortality

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    within 5 years of enrollment

Secondary Outcomes (5)

  • Blood pressure control

    within 5 years of enrollment

  • Total cholesterol control

    within 5 years of enrollment

  • Low density cholesterol control

    within 5 years of enrollment

  • Triglycerides control

    within 5 years of enrollment

  • Weight control

    within 5 years of enrollment

Study Arms (2)

Community-based nurse care management

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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

Interventions

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.

Also known as: Health Quality Partners, Medicare Coordinated Care Demonstration, Care Coordination, Disease Management
Community-based nurse care management

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Quality Partners

Doylestown, Pennsylvania, 18902, United States

Location

Related Publications (4)

  • 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.

    PMID: 19211468BACKGROUND
  • 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.

    PMID: 19040171BACKGROUND
  • 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.

    PMID: 19124858BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Heart FailureCoronary DiseaseDiabetes MellitusAsthmaHypertensionHypercholesterolemia

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Kenneth D Coburn, MD, MPH

    Health Quality Partners

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

February 19, 2010

Study Start

April 1, 2002

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations