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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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

5000

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • Brooklyn、New York、アメリカ、11209
        • VA NYHHS Brooklyn Campus
      • New York、New York、アメリカ、10010
        • VA NYHHS Manhattan Campus

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • non-specialized primary care clinical microsystems

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
実験的: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.
他の名前:
  • Panel management assistant
実験的: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.
他の名前:
  • 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.
他の名前:
  • 教育的介入

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Smoking Status
時間枠:Baseline and 12 months
clinical outcome
Baseline and 12 months
Change in Blood Pressure Reading
時間枠:Baseline and 12 months
clinical outcome
Baseline and 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in weight
時間枠:Baseline and most recent at 12 months
Baseline and most recent at 12 months
Change in Patient Activation
時間枠: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
時間枠:6 months and 12 months
6 months and 12 months
Change in Provider Behavior change expertise
時間枠:6 months and 12 months
6 months and 12 months
Change in Provider Self-efficacy with Panel Management Tasks
時間枠:Baseline and 12 months
Baseline and 12 months
Change in Provider Job Satisfaction
時間枠:Baseline and 12 months
Baseline and 12 months
Change in Microsystem function and collective efficacy
時間枠: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
時間枠:Baseline and 12 months
Baseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study arm
時間枠:Baseline and 12 months
Baseline and 12 months
Change in Proportion of smokers on the panel received any cessation medications
時間枠:Baseline and 12 months
This information will be culled from the Vista Smoking Database
Baseline and 12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Health care usage
時間枠: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
時間枠:Baseline and 12 months
Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
Baseline and 12 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Mark D Schwartz、VA New York Harbor Healthcare System
  • 主任研究者:Scott Sherman, M.D., M.P.H.、VA New York Harbor Healthcare System
  • スタディディレクター:Colleen Gillespie, PhD、NYU Langone Health
  • スタディディレクター:Anne Dembitzer, M.D.、VA New York Harbor Healthcare System

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年9月1日

一次修了 (実際)

2014年8月31日

研究の完了 (実際)

2015年8月31日

試験登録日

最初に提出

2012年8月28日

QC基準を満たした最初の提出物

2012年8月29日

最初の投稿 (見積もり)

2012年9月3日

学習記録の更新

投稿された最後の更新 (実際)

2018年5月7日

QC基準を満たした最後の更新が送信されました

2018年5月1日

最終確認日

2018年5月1日

詳しくは

本研究に関する用語

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