Guided Care: Integrating High Tech and High Touch
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|ClinicalTrials.gov Identifier: NCT00121940|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : April 20, 2012
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 or disease||Intervention/treatment||Phase|
|Chronic Disease||Behavioral: Guided Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||904 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Guided Care: Integrating High Tech and High Touch|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
|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|
- SF-36 Physical Health Summary Scale [ Time Frame: Baseline, 6, 18, and 32 months ]
- SF-36 Mental Health Summary Scale [ Time Frame: Baseline, 6, 18, and 32 months ]
- Health Services Utilization [ Time Frame: Baseline, 8, 20, and 32 months ]Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data
- Perceived Quality of Care [ Time Frame: Baseline, 6, 18, and 32 months ]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 ]
- Physician Satisfaction with Care [ Time Frame: Baseline, 12, 24, and 36 months ]
- Caregiver Burden [ Time Frame: Baseline, 6, and 18 months ]Using Modified Caregiver Strain Index
- Self-rated Health [ Time Frame: Baseline, 6, 18, and 32 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121940
|United States, Maryland|
|Johns Hopkins University Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Charles Boult, MD, MPH, MBA||Johns Hopkins Bloomberg School of Public Health|