Guided Care: Integrating High Tech and High Touch
|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|
|Chronic Disease||Behavioral: Guided Care|
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|
|Primary Completion Date :||June 2009|
|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 ]
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|