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临床试验/NCT00121940
NCT00121940已完成不适用

Guided Care: Integrating High Tech and High Touch

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 904 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
904
试验地点
2
主要终点
Health Services Utilization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Moving out of area
  • Currently assigned to case manager/in case management program
  • Cognitive impairment and no legal representative

结局指标

主要结局

Health Services Utilization

时间窗: Baseline, 8, 20, and 32 months

Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data

SF-36 Physical Health Summary Scale

时间窗: Baseline, 6, 18, and 32 months

SF-36 Mental Health Summary Scale

时间窗: Baseline, 6, 18, and 32 months

次要结局

  • Physician Satisfaction with Care(Baseline, 12, 24, and 36 months)
  • Caregiver Burden(Baseline, 6, and 18 months)
  • Self-rated Health(Baseline, 6, 18, and 32 months)
  • Perceived Quality of Care(Baseline, 6, 18, and 32 months)
  • Patient Satisfaction with Care(Baseline, 6, 18, and 32 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Boult

Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (2)

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