Web-Enhanced Guideline Implementation for Post MI CBOC Patients (VA MI Plus)
2015年6月24日 更新者：US Department of Veterans Affairs
MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in managing complex patients by providing a single, interactive, and personalized source of information regarding applicable guidelines for post-MI patients.
Specifically, 1) the investigators will identify barriers to provider adherence to guidelines within VHA clinics; 2) Apply guideline-based performance measures to electronic medical records (CPRS) and associated administrative data; 3) Implement the interactive Internet intervention developed by the NHLBI study, after inclusion of VA-specific components, including performance feedback for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness, sustainability, and cost-effectiveness in both the VA and Medicare populations.
This will include a randomized controlled trial with the CBOC as a unit of randomization.
調査の概要
詳細な説明
Some 7.1 million Americans and an estimated 250,000 Veterans actively using VHA are Myocardial Infarction (MI) survivors.
To date, most guideline interventions focus on a single patient condition, but ambulatory post-MI patients are frequently more complex, multiple comorbidities, and conflicting guidelines applicable to them.
For example, whereas JNC-6 guidelines for the treatment of hypertension suggest pharmacological treatment at blood pressures above 140/80 mm Hg, to be initiated with diuretics or beta-blockers as first line agents, other guidance suggests that for post-MI patients with diabetes, treatment cut-offs should be lower and ACE-inhibitors may be considered as optimal first-line agents.
On October 1, 2002, the University of Alabama at Birmingham (UAB) began a study funded by the National Heart, Lung, and Blood institute (NHLBI) as an RO1 (Kiefe, PI (25%), Weissman, co-PI (20%)) to conduct a randomized trial, MI-plus to increase provider adherence to guidelines for post-MI patients.
That NHLBI-funded study targets Medicare beneficiaries and their primary care providers in Alabama.
Its primary goal is to develop and test with a randomized controlled trial, an Internet-based multimodal guideline implementation strategy.
The investigators propose, herewith, to extend and adapt this study to a nationwide sample of VA post-MI patients and their primary care providers in the VA.
研究の種類
介入
入学 (実際)
847
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
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Alabama
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Birmingham、Alabama、アメリカ、35233
- VA Medical Center, Birmingham
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Arizona
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Phoenix、Arizona、アメリカ、85012
- Carl T. Hayden VA Medical Center
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Arkansas
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Fayetteville、Arkansas、アメリカ、72703
- Fayetteville, AR
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California
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Long Beach、California、アメリカ、90822
- Long Beach
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San Francisco、California、アメリカ、94121
- VA Medical Center
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA Connecticut Health Care System (West Haven)
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Florida
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Bay Pines、Florida、アメリカ、33708
- Bay Pines VA Healthcare System, Pay Pines, FL
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Miami、Florida、アメリカ、33125
- VA Medical Center, Miami
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Georgia
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Decatur、Georgia、アメリカ、30033
- VA Medical Center, Decatur
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Illinois
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Chicago、Illinois、アメリカ、60612
- Jesse Brown VAMC (WestSide Division)
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Danville、Illinois、アメリカ、61832
- VA Illiana Health Care System
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Iowa
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Iowa City、Iowa、アメリカ、52246
- VA Medical Center Iowa City
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Kansas
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Topeka、Kansas、アメリカ、66622
- VA Eastern Kansas Health Care System - Topeka
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Wichita、Kansas、アメリカ、67218
- Robert J. Dole VAMC & ROC
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Kentucky
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Louisville、Kentucky、アメリカ、40206
- VA Medical Center, Louisville
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Louisiana
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Shreveport、Louisiana、アメリカ、71101
- Overton Brooks VA Medical Center, Shreveport, LA
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Massachusetts
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Bedford、Massachusetts、アメリカ、01730
- Edith Nourse Rogers Memorial Veterans Hospital
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Boston、Massachusetts、アメリカ、02130
- VA Boston Health Care System, Jamaica Plain
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Michigan
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Ann Arbor、Michigan、アメリカ、48105
- VA Ann Arbor Healthcare System
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Battle Creek、Michigan、アメリカ、49015
- Battle Creek, MI
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Mississippi
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Biloxi、Mississippi、アメリカ、39531
- VA Gulf Coast Veterans Health Care System
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Missouri
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Columbia、Missouri、アメリカ、65201-5297
- Harry S. Truman Memorial VA Medical Center
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Kansas City、Missouri、アメリカ、64128
- Kansas City VA Medical Center
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St Louis、Missouri、アメリカ、63106
- VA Medical Center, St Louis
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New Jersey
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East Orange、New Jersey、アメリカ、07018
- VA New Jersey Health Care System, East Orange
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New York
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Albany、New York、アメリカ、12208
- Albany VA Medical Center: Samuel S. Stratton
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Albany、New York、アメリカ、12208
- No Longer Valid, Use 528A8
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Montrose、New York、アメリカ、10548
- Franklin Delano Roosevelt Campus of VAHVHCS
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New York、New York、アメリカ、10010
- New York, NY
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Ohio
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Cincinnati、Ohio、アメリカ、45220
- VA Medical Center, Cincinnati
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Cleveland、Ohio、アメリカ、44106-3800
- VA Medical Center, Cleveland
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Pennsylvania
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Coatesville、Pennsylvania、アメリカ、19320
- Coatesville, PA
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Lebanon、Pennsylvania、アメリカ、17042
- Lebanon, PA
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Rhode Island
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Providence、Rhode Island、アメリカ、02908-4799
- VA Medical Center, Providence
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South Carolina
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Charleston、South Carolina、アメリカ、29401-5799
- Ralph H Johnson VA Medical Center, Charleston
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Tennessee
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Nashville、Tennessee、アメリカ、37212-2637
- VA Medical Center
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Utah
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Salt Lake City、Utah、アメリカ、84148
- VA Salt Lake City Health Care System, Salt Lake City
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Vermont
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White River Junction、Vermont、アメリカ、05009-0001
- VA Medical & Regional Office Center, White River
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- William S. Middleton Memorial Veterans Hospital
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Milwaukee、Wisconsin、アメリカ、53295-1000
- Clement J. Zablocki VAMC
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San Juan、プエルトリコ、00921-3201
- San Juan Vamc
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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
- 子
- 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:
Potential subjects are defined as any VA-employed physician, PA, or CRNP who is a CBOC provider. All such providers will be offered the opportunity to participate and will have the option to agree to participate or not. Performance measure data from records of post-MI patients of the above providers will be extracted to test the experimental intervention. (Note: No individually identifying patient information will be extracted.) All VA-employed CBOC providers (physicians, PAs, CRNPs) will be offered the opportunity to participate in this study. Any subject may refuse to participate or to discontinue participation at will at any point in the study without consequence.
Exclusion Criteria:
Potential subjects must be VA-employed physician, PA, or CRNP who is a CBOC provider. No such healthcare providers will be excluded from the study.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：アーム1
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The experimental intervention, customized to the individual clinician in real-time consists of Internet learning modules integrating case-based education with audit, feedback, and benchmarking of practice profiles.
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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 |
|---|---|---|
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Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators
時間枠：1/1/02 - 12/31/08
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The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics.
Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator.
1) change in the percentage of patients with improvements in LDL.
Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c.
Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).
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1/1/02 - 12/31/08
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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：Thomas K Houston, MD MPH、Edith Nourse Rogers Memorial Veterans Hospital, Bedford
- 主任研究者：Ellen Funkhouser, DrPH MS BS、VA Medical Center, Birmingham
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。
一般刊行物
- Funkhouser E, Houston TK, Levine DA, Richman J, Allison JJ, Kiefe CI. Physician and patient influences on provider performance: beta-blockers in postmyocardial infarction management in the MI-Plus study. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):99-106. doi: 10.1161/CIRCOUTCOMES.110.942318. Epub 2010 Dec 7.
- Schoen MJ, Tipton EF, Houston TK, Funkhouser E, Levine DA, Estrada CA, Allison JJ, Williams OD, Kiefe CI. Characteristics that predict physician participation in a Web-based CME activity: the MI-Plus study. J Contin Educ Health Prof. 2009 Fall;29(4):246-53. doi: 10.1002/chp.20043.
- Levine DA, Funkhouser EM, Houston TK, Gerald JK, Johnson-Roe N, Allison JJ, Richman J, Kiefe CI. Improving care after myocardial infarction using a 2-year internet-delivered intervention: the Department of Veterans Affairs myocardial infarction-plus cluster-randomized trial. Arch Intern Med. 2011 Nov 28;171(21):1910-7. doi: 10.1001/archinternmed.2011.498.
- Funkhouser E, Levine DA, Gerald JK, Houston TK, Johnson NK, Allison JJ, Kiefe CI. Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study. Implement Sci. 2011 Sep 9;6:105. doi: 10.1186/1748-5908-6-105.
- Ahern DK, Woods SS, Lightowler MC, Finley SW, Houston TK. Promise of and potential for patient-facing technologies to enable meaningful use. Am J Prev Med. 2011 May;40(5 Suppl 2):S162-72. doi: 10.1016/j.amepre.2011.01.005.
- Houston TK, Funkhouser E, Allison JJ, Levine DA, Williams OD, Kiefe CI. Multiple measures of provider participation in Internet delivered interventions. Stud Health Technol Inform. 2007;129(Pt 2):1401-5.
- Bloch MJ, Basile JN. Analysis of Recent Papers in Hypertension. J Clin Hypertens (Greenwich). 2009 May;11(5):292-95. doi: 10.1111/j.1751-7176.2009.00115.x. No abstract available.
- Basile J. Shifting paradigms in defining and treating hypertension: addressing global risk with combination therapy. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):2-3. doi: 10.1111/j.1524-6175.2007.08026.x. No abstract available.
- Basile J. The importance of prompt blood pressure control. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):13-9. doi: 10.1111/j.1524-6175.2007.08027.x.
- Jamerson KA, Basile J. Prompt, aggressive BP lowering in high-risk patients. J Clin Hypertens (Greenwich). 2008 Jan;10(1 Suppl 1):40-8. doi: 10.1111/j.1524-6175.2007.08145.x.
- Cushman WC, Ford CE, Einhorn PT, Wright JT Jr, Preston RA, Davis BR, Basile JN, Whelton PK, Weiss RJ, Bastien A, Courtney DL, Hamilton BP, Kirchner K, Louis GT, Retta TM, Vidt DG; ALLHAT Collaborative Research Group. Blood pressure control by drug group in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2008 Oct;10(10):751-60. doi: 10.1111/j.1751-7176.2008.00015.x.
- Yu FB, Menachemi N, Berner ES, Allison JJ, Weissman NW, Houston TK. Full implementation of computerized physician order entry and medication-related quality outcomes: a study of 3364 hospitals. Am J Med Qual. 2009 Jul-Aug;24(4):278-86. doi: 10.1177/1062860609333626. Epub 2009 Jun 5.
- Levine DA, Allison JJ, Cherrington A, Richman J, Scarinci IC, Houston TK. Disparities in self-monitoring of blood glucose among low-income ethnic minority populations with diabetes, United States. Ethn Dis. 2009 Spring;19(2):97-103.
- Houston TK, Richman JS, Ray MN, Allison JJ, Gilbert GH, Shewchuk RM, Kohler CL, Kiefe CI; DPBRN Collaborative Group. Internet delivered support for tobacco control in dental practice: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e38. doi: 10.2196/jmir.1095.
- Miller MJ, Allison JJ, Schmitt MR, Ray MN, Funkhouser EM, Cobaugh DJ, Saag KG, LaCivita C. Using single-item health literacy screening questions to identify patients who read written nonsteroidal anti-inflammatory medicine information provided at pharmacies. J Health Commun. 2010 Jun;15(4):413-27. doi: 10.1080/10810731003753091.
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
2003年9月1日
一次修了 (実際)
2010年6月1日
研究の完了 (実際)
2010年6月1日
試験登録日
最初に提出
2005年8月2日
QC基準を満たした最初の提出物
2005年8月2日
最初の投稿 (見積もり)
2005年8月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年7月23日
QC基準を満たした最後の更新が送信されました
2015年6月24日
最終確認日
2015年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
VA MI Plus Interactiveの臨床試験
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University of California, DavisNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Kaiser Foundation...招待による登録