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Program for Research on the Outcomes of VA Education (PROVE)

2018年5月1日 更新者:Mark Schwartz、VA New York Harbor Healthcare System

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

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.

研究概览

详细说明

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:

The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is delivered through two teams at the Manhattan and five teams at the Brooklyn campuses. Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting contamination in this study.

研究类型

介入性

注册 (实际的)

5000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Brooklyn、New York、美国、11209
        • VA NYHHS Brooklyn Campus
      • New York、New York、美国、10010
        • VA NYHHS Manhattan Campus

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:PM-Data
Team will receive data only.
The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
实验性的:PM-Support
Team will receive data and panel management support
The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
PMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
其他名称:
  • Panel management assistant
实验性的:PM-Education
Team will receive data, panel management support, and educational interventions.
The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
PMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
其他名称:
  • Panel management assistant
The educational intervention will be administered throughout the duration of the study. Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology). Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning. Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation. It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback. After the first three months, academic detailing will only be implemented on an as-needed basis.
其他名称:
  • 教育干预

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Smoking Status
大体时间:Baseline and 12 months
clinical outcome
Baseline and 12 months
Change in Blood Pressure Reading
大体时间:Baseline and 12 months
clinical outcome
Baseline and 12 months

次要结果测量

结果测量
措施说明
大体时间
Change in weight
大体时间:Baseline and most recent at 12 months
Baseline and most recent at 12 months
Change in Patient Activation
大体时间:6 months and 12 months
The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
6 months and 12 months
Change in Patient Perceptions of Quality of Care
大体时间:6 months and 12 months
6 months and 12 months
Change in Provider Behavior change expertise
大体时间:6 months and 12 months
6 months and 12 months
Change in Provider Self-efficacy with Panel Management Tasks
大体时间:Baseline and 12 months
Baseline and 12 months
Change in Provider Job Satisfaction
大体时间:Baseline and 12 months
Baseline and 12 months
Change in Microsystem function and collective efficacy
大体时间:Baseline and 12 months
Baseline and 12 months
Change in Provider's assessments of training that they received in panel management and working within a PACT team
大体时间:Baseline and 12 months
Baseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study arm
大体时间:Baseline and 12 months
Baseline and 12 months
Change in Proportion of smokers on the panel received any cessation medications
大体时间:Baseline and 12 months
This information will be culled from the Vista Smoking Database
Baseline and 12 months

其他结果措施

结果测量
措施说明
大体时间
Change in Health care usage
大体时间:Baseline and 12 months
Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
Baseline and 12 months
Change in Patient-level costs
大体时间:Baseline and 12 months
Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
Baseline and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mark D Schwartz、VA New York Harbor Healthcare System
  • 首席研究员:Scott Sherman, M.D., M.P.H.、VA New York Harbor Healthcare System
  • 研究主任:Colleen Gillespie, PhD、NYU Langone Health
  • 研究主任:Anne Dembitzer, M.D.、VA New York Harbor Healthcare System

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年9月1日

初级完成 (实际的)

2014年8月31日

研究完成 (实际的)

2015年8月31日

研究注册日期

首次提交

2012年8月28日

首先提交符合 QC 标准的

2012年8月29日

首次发布 (估计)

2012年9月3日

研究记录更新

最后更新发布 (实际的)

2018年5月7日

上次提交的符合 QC 标准的更新

2018年5月1日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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