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临床试验/NCT01677533
NCT01677533已完成不适用

Program for Research on the Outcomes of VA Education: Controlled Study of Panel Management and Microsystem Education Interventions to Improve Outcomes in Hypertension and Smoking Cessation

VA New York Harbor Healthcare System3 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000
试验地点
3
主要终点
Change in Smoking Status

研究概览

简要总结

The PROVE aims to test the efficacy of panel management support and educational intervention in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.It is hypothesized that the group receiving panel management and educational interventions will have better smoking cessation and hypertension outcomes than the group receiving only panel management assistance. It is further supposed that the later will have better smoking cessation and hypertension patient outcomes than the data-only group.

详细描述

Objective:

The specific aims for this study are: (1) to identify health professional educational and clinical microsystem determinants of outcomes for hypertension and smoking cessation in veterans. (2) to test the efficacy of three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.

Research design:

This project will consist of two phases. Phase I (one year) is the development of the necessary measurement and data infrastructure to assess health professional education, microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will conduct a clinical demonstration project, comparing three interventions in a randomized controlled trial. Primary care teams will be randomly allocated to one of three arms: 1) panel management data, 2) panel management data and support, and 3) panel management data, support and education. The investigators will assess the impact of the implementation of panel management on primary patient outcomes in hypertension and smoking cessation (blood pressure and quit rates). The investigative team will also assess the impact of the implementation of panel management on secondary, intermediary, patient (patient activation, adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign of patient processes and provider roles/responsibilities, use of panel management strategies).

Methodology:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • non-specialized primary care clinical microsystems

排除标准

  • specialized clinical microsystems
  • pilot clinical patient-aligned care teams

研究组 & 干预措施

PM-Data

Active Comparator

Team will receive data only.

干预措施: Data (Other)

PM-Support

Experimental

Team will receive data and panel management support

干预措施: Data (Other)

PM-Support

Experimental

Team will receive data and panel management support

干预措施: Panel Management Support (Other)

PM-Education

Experimental

Team will receive data, panel management support, and educational interventions.

干预措施: Education (Other)

PM-Education

Experimental

Team will receive data, panel management support, and educational interventions.

干预措施: Data (Other)

PM-Education

Experimental

Team will receive data, panel management support, and educational interventions.

干预措施: Panel Management Support (Other)

结局指标

主要结局

Change in Smoking Status

时间窗: Baseline and 12 months

clinical outcome

Change in Blood Pressure Reading

时间窗: Baseline and 12 months

clinical outcome

次要结局

  • Change in weight(Baseline and most recent at 12 months)
  • Change in Provider Self-efficacy with Panel Management Tasks(Baseline and 12 months)
  • Change in Proportion of smokers on the panel received any cessation medications(Baseline and 12 months)
  • Change in Patient Activation(6 months and 12 months)
  • Change in Provider Job Satisfaction(Baseline and 12 months)
  • Change in Provider's assessments of training that they received in panel management and working within a PACT team(Baseline and 12 months)
  • Change in Proportion of panel smokers offered smoking cessation resources by study arm(Baseline and 12 months)
  • Change in Patient Perceptions of Quality of Care(6 months and 12 months)
  • Change in Provider Behavior change expertise(6 months and 12 months)
  • Change in Microsystem function and collective efficacy(Baseline and 12 months)

研究者

发起方
VA New York Harbor Healthcare System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Mark Schwartz

Primary Care Physician

VA New York Harbor Healthcare System

研究点 (3)

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