NCT00121940

Guided Care: Integrating High Tech and High Touch

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 904 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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-, 24-, and 32-month follow-up intervals. The primary outcome variables are the participants' physical health and mental health (SF-36 Summary Scales) and health services utilization. Secondary outcome variables include: the quality of care; unpaid caregivers' burden; self-rated health; patient 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.

Conditions

• Chronic Disease

Interventions

Type	Name	Description
BEHAVIORAL	Guided Care	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.

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2005-07-21
• Last updated: 2012-04-20

Locations

1 site across 1 country: United States