Guided Care: Integrating High Tech and High Touch

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Guided Care

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.

• Study Type: Interventional
• Enrollment (Actual): 904
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University Bloomberg School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
Experimental: Guided Care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Quality of Care	Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)	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	Using Modified Caregiver Strain Index	Baseline, 6, and 18 months
Self-rated Health		Baseline, 6, 18, and 32 months

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Aging (NIA); Agency for Healthcare Research and Quality (AHRQ); The Jacob and Valeria Langeloth Foundation; The John A. Hartford Foundation
• Investigators: Principal Investigator: Charles Boult, MD, MPH, MBA, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 18, 2005
• First Submitted That Met QC Criteria: July 18, 2005
• First Posted (Estimate): July 21, 2005

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 18, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Caregivers; Chronic Disease; Nurses; Support Groups
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: R01HS014580-01A1 (U.S. AHRQ Grant/Contract); HS014580 (Other Identifier: NIA- Administrative Supplement); 5R03HS018256 (U.S. AHRQ Grant/Contract)