跳至主要内容
临床试验/NCT00126750
NCT00126750已完成不适用

MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients

US Department of Veterans Affairs80 个研究点 分布在 2 个国家目标入组 847 人开始时间: 2003年9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
847
试验地点
80
主要终点
Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators

研究概览

简要总结

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.

详细描述

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators

时间窗: 1/1/02 - 12/31/08

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%).

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (80)

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