Guided Care: Integrating High Tech and High Touch

This study has been completed.
Sponsor:
Collaborators:
The John A. Hartford Foundation
The Jacob and Valeria Langeloth Foundation
Information provided by (Responsible Party):
Charles Boult, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00121940
First received: July 18, 2005
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention
Chronic Disease
Behavioral: Guided Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Guided Care: Integrating High Tech and High Touch

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • SF-36 Physical Health Summary Scale [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
  • SF-36 Mental Health Summary Scale [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
  • Health Services Utilization [ Time Frame: Baseline, 8, 20, and 32 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
    Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)

  • Patient Satisfaction with Care [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]
  • Physician Satisfaction with Care [ Time Frame: Baseline, 12, 24, and 36 months ] [ Designated as safety issue: No ]
  • Caregiver Burden [ Time Frame: Baseline, 6, and 18 months ] [ Designated as safety issue: No ]
    Using Modified Caregiver Strain Index

  • Self-rated Health [ Time Frame: Baseline, 6, 18, and 32 months ] [ Designated as safety issue: No ]

Enrollment: 904
Study Start Date: February 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Usual 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121940

Locations
United States, Maryland
Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
The John A. Hartford Foundation
The Jacob and Valeria Langeloth Foundation
Investigators
Principal Investigator: Charles Boult, MD, MPH, MBA Johns Hopkins Bloomberg School of Public Health
  More Information

Additional Information:
No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles Boult, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00121940     History of Changes
Other Study ID Numbers: RO1 HS014580-01A1, HS014580, 5R03HS018256
Study First Received: July 18, 2005
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Chronic Disease
Nurses
Caregivers
Support Groups

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014