NCT00121940

Brief Summary

The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of the health and well-being of the frail elderly. A specially trained registered nurse will work closely with 1-3 primary care physicians to provide the most complex older patients (and their unpaid caregivers) with health care that is comprehensive, coordinated, patient-centered, and proactive. The study will evaluate the effects of Guided Care on:

  • older persons' physical and mental health, health services utilization, quality of care, self-efficacy, and satisfaction with care;
  • older persons' unpaid caregivers' burden; and
  • primary care physicians' satisfaction with their care of chronically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
904

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

July 18, 2005

Last Update Submit

April 18, 2012

Conditions

Chronic Disease

Keywords

Chronic DiseaseNursesCaregiversSupport Groups

Outcome Measures

Primary Outcomes (3)

  • SF-36 Physical Health Summary Scale

    Baseline, 6, 18, and 32 months

  • SF-36 Mental Health Summary Scale

    Baseline, 6, 18, and 32 months

  • Health Services Utilization

    Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data

    Baseline, 8, 20, and 32 months

Secondary Outcomes (5)

  • Perceived Quality of Care

    Baseline, 6, 18, and 32 months

  • Patient Satisfaction with Care

    Baseline, 6, 18, and 32 months

  • Physician Satisfaction with Care

    Baseline, 12, 24, and 36 months

  • Caregiver Burden

    Baseline, 6, and 18 months

  • Self-rated Health

    Baseline, 6, 18, and 32 months

Study Arms (2)

Guided Care

EXPERIMENTAL
Behavioral: Guided Care

Usual Care

NO INTERVENTION

Interventions

Guided CareBEHAVIORAL

Specially trained registered nurse (Guided Care Nurse) based in a primary care practice collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; "best practices" for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources.

Guided Care

Eligibility Criteria

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

You may qualify if:

  • Over 65
  • Insured by KPMAG, USFHP/TRICARE, or Medicare FFS
  • High likelihood of use of services in the coming year based on predictive modeling using current year's health care expenses

You may not qualify if:

  • Moving out of area
  • Currently assigned to case manager/in case management program
  • Cognitive impairment and no legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Boult C, Reider L, Leff B, Frick KD, Boyd CM, Wolff JL, Frey K, Karm L, Wegener ST, Mroz T, Scharfstein DO. The effect of guided care teams on the use of health services: results from a cluster-randomized controlled trial. Arch Intern Med. 2011 Mar 14;171(5):460-6. doi: 10.1001/archinternmed.2010.540.

    PMID: 21403043DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charles Boult, MD, MPH, MBA

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Start

February 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

US(1)