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Guided Care: Integrating High Tech and High Touch

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Care
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring Chronic Disease, Nurses, Caregivers, Support Groups

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

  • Johns Hopkins University Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Guided Care

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

SF-36 Physical Health Summary Scale
SF-36 Mental Health Summary Scale
Health Services Utilization
Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data

Secondary Outcome Measures

Perceived Quality of Care
Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)
Patient Satisfaction with Care
Physician Satisfaction with Care
Caregiver Burden
Using Modified Caregiver Strain Index
Self-rated Health

Full Information

First Posted
July 18, 2005
Last Updated
April 18, 2012
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ), National Institute on Aging (NIA), The John A. Hartford Foundation, The Jacob and Valeria Langeloth Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00121940
Brief Title
Guided Care: Integrating High Tech and High Touch
Official Title
Guided Care: Integrating High Tech and High Touch
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ), National Institute on Aging (NIA), The John A. Hartford Foundation, The Jacob and Valeria Langeloth Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Chronic Disease, Nurses, Caregivers, Support Groups

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
904 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Care
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Guided Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
SF-36 Physical Health Summary Scale
Time Frame
Baseline, 6, 18, and 32 months
Title
SF-36 Mental Health Summary Scale
Time Frame
Baseline, 6, 18, and 32 months
Title
Health Services Utilization
Description
Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data
Time Frame
Baseline, 8, 20, and 32 months
Secondary Outcome Measure Information:
Title
Perceived Quality of Care
Description
Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)
Time Frame
Baseline, 6, 18, and 32 months
Title
Patient Satisfaction with Care
Time Frame
Baseline, 6, 18, and 32 months
Title
Physician Satisfaction with Care
Time Frame
Baseline, 12, 24, and 36 months
Title
Caregiver Burden
Description
Using Modified Caregiver Strain Index
Time Frame
Baseline, 6, and 18 months
Title
Self-rated Health
Time Frame
Baseline, 6, 18, and 32 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Boult, MD, MPH, MBA
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21403043
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.
Results Reference
derived
Links:
URL
http://www.guidedcare.org
Description
Related Info

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Guided Care: Integrating High Tech and High Touch

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