Clinical trial NCT00121940: Guided Care: Integrating High Tech and High Touch
Official title: Guided Care: Integrating High Tech and High Touch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Chronic Disease
Nurses
Caregivers
Support Groups
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: National Institute on Aging (NIA)
name: The John A. Hartford Foundation
name: The Jacob and Valeria Langeloth Foundation
First posted: 2005-07-21
Enrollment: 904
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SF-36 Physical Health Summary Scale
timeFrame: Baseline, 6, 18, and 32 months
measure: SF-36 Mental Health Summary Scale
timeFrame: Baseline, 6, 18, and 32 months
measure: Health Services Utilization
timeFrame: Baseline, 8, 20, and 32 months
Secondary outcomes:
measure: Perceived Quality of Care
timeFrame: Baseline, 6, 18, and 32 months
measure: Patient Satisfaction with Care
timeFrame: Baseline, 6, 18, and 32 months
measure: Physician Satisfaction with Care
timeFrame: Baseline, 12, 24, and 36 months
measure: Caregiver Burden
timeFrame: Baseline, 6, and 18 months
measure: Self-rated Health
timeFrame: Baseline, 6, 18, and 32 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Charles Boult, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.