Guided Care: Integrating High Tech and High Touch

Chronic Disease Clinical Trial

Official title:

Guided Care: Integrating High Tech and High Touch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121940
• Other study ID #: RO1 HS014580-01A1
• Secondary ID: HS0145805R03HS01
• Status: Completed
• Phase: N/A
• First received: July 18, 2005
• Last updated: April 18, 2012
• Start date: February 2006
• Est. completion date: June 2009

Study information

• Verified date: April 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 904
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Agency for Healthcare Research and Quality (AHRQ), National Institute on Aging (NIA), The Jacob and Valeria Langeloth Foundation, The John A. Hartford Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 Physical Health Summary Scale		Baseline, 6, 18, and 32 months	No
Primary	SF-36 Mental Health Summary Scale		Baseline, 6, 18, and 32 months	No
Primary	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	No
Secondary	Perceived Quality of Care	Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)	Baseline, 6, 18, and 32 months	No
Secondary	Patient Satisfaction with Care		Baseline, 6, 18, and 32 months	No
Secondary	Physician Satisfaction with Care		Baseline, 12, 24, and 36 months	No
Secondary	Caregiver Burden	Using Modified Caregiver Strain Index	Baseline, 6, and 18 months	No
Secondary	Self-rated Health		Baseline, 6, 18, and 32 months	No

External Links

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