CRP, high-sensitivity |
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Clinical Trial: Guided Care: Integrating High Tech and High Touch
This study is not yet open for patient recruitment.
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Purpose
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 (primary outcomes), quality of care, self-efficacy, and satisfaction with care;
- older persons'''' unpaid caregivers'''' burden, health, costs and satisfaction with care; and
- primary care physicians'''' satisfaction with their care of chronically ill patients.
| Condition | Intervention |
|---|---|
| Chronic Disease | Behavior: Guided Care |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: Cost of care (based on claims data)
Expected Total Enrollment: 580
Study start: April 2006; Expected completion: June 2010
Last follow-up: September 2008; Data entry closure: June 2009
Health care for older Americans with chronic conditions is often fragmented and provider-centric. In response, a team of investigators at Johns Hopkins University has translated the scientific principles of seven successful innovations into one patient-centered system of care. Supported by evidence-based guidelines and state-of-the-art information technology, “Guided Care” is undergoing a 12-month pilot test in older primary care patients with complex needs. A specially trained Guided Care nurse (GCN), 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.
The proposed multi-site study will measure the effects of Guided Care on the quality and outcomes of care for high-risk older persons, their unpaid caregivers, and their primary care physicians. The panels of 53 physicians in 7 practices will be screened to identify 1350 high-risk older patients. After about 850 have given informed consent and baseline interviews, clusters of 2-5 physicians at each practice site will be randomized to provide either Guided Care or usual care to their consenting patients. Each physician cluster in the Guided Care group will incorporate a GCN into its practice; the physician clusters in the control group will not.
Interviews and queries of administrative databases will provide evaluative data at baseline and at 12- and 24-month follow-up intervals. The primary outcome variable is the participants'''' physical health and mental health (SF-36 Summary Scales). Secondary outcome variables include: the quality of care; unpaid caregivers’ burden, costs, health, and satisfaction; and primary care physicians’ satisfaction. Intention-to-treat analyses will have 85% power (range of 70-97%) to detect clinically meaningful differences between the two groups.
The study is designed to facilitate the prompt dissemination of Guided Care, if the results of the trial are favorable. A stakeholders’ advisory board, representing consumers, providers, delivery systems, insurers, regulators and policy-makers, will inform the operation and evaluation of the study – and it will facilitate the subsequent dissemination of its tools and technology throughout American health care.
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- 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
Exclusion Criteria:
- Moving out of area
- Currently assigned to case manager/in case management program
- Cognitive impairment and no legal representative
Location and Contact Information
Charles Boult, MD, MPH, MBA, Principal Investigator, Johns Hopkins Bloomberg School of Public Health
More Information
Record last reviewed: May 2005
Last Updated: July 25, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00121940
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26

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