Personal Digital Assistant for Guideline Adherence Trial

描述(由申请人提供)： 拟议试验的目的是测试一种新的基于实践的干预措施的影响，包括使用基于个人数字助理(PDA)的决策支持，在初级护理实践中遵守复杂的临床实践指南(CPG)。我们选择了成人高胆固醇血症检测、评估和治疗专家小组的第三份报告(ATP111)指南，因为它很复杂，包括筛查标准、风险分层和针对风险组的治疗建议。这项基于实践的随机对照试验将检验主要假设，即干预措施将使接受适当降脂药物治疗的筛查成年人的比例净增加。我们将估算这一主要终点干预措施的边际成本效益。其他结果将包括适当的患者比例：1)控制在低密度脂蛋白胆固醇目标，2)筛查，3)风险分层，4)关于治疗生活方式改变的咨询。我们将探索干预对基线观察到的护理差异的影响。干预将在随机化(实践)的层面上进行，并将包括学术细节和关于使用基于掌上电脑的决策支持工具的培训。所有做法(n=)都将得到通常的照顾，包括分发指导方针、基线绩效反馈和继续教育。结果将基于基线的患者水平数据和符合胆固醇测量条件的成年患者(N-20,000)的后续图表审查来评估。将使用适当的方法来分析这些相关数据。影响评估将通过对参与调查的医生和工作人员进行基线调查和后续调查进行。将通过跟踪基于PDA的工具的使用情况进行流程评估。我们估计，如果充分改善对ATPIII的遵守，美国每年可以避免多达4.8万起重大冠心病事件。如果这一干预措施取得成功，就可以使用电子决策支持工具来促进其他复杂的国家方案的执行。因此，这一创新战略很有希望通过预防心血管疾病和随后转变为其他重要情况来对公共卫生产生重大影响。

DESCRIPTION (provided by the applicant): The goal of the proposed trial is to test the impact of a novel practice-based intervention, including the use of personal digital assistant (PDA) based decision support, on adherence with a complex clinical practice guideline (CPG) in primary carepractices. We have chosen the Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP 111) guideline as it is complex, including screening criteria, risk stratification, and risk-group specific treatment recommendations. This randomized, controlled practice-based trial will test the primary hypothesis that intervention practices will have a net increase in the proportion of screened adults that is treated appropriately with lipid-lowering drug therapy. We will estimate the marginal cost effectiveness of the intervention for this primary endpoint. Other outcomes will include the proportions of patients that is appropriately 1) controlled to low density lipoprotein cholesterol goal, 2) screened, 3) risk-stratified, and 4) counseled regarding therapeutic lifestyle changes. We will explore the intervention effect on disparities in care observed at baseline. The intervention will be delivered at the level of randomization (the practice) and will include academic detailing and training on use of the PDA-based decision support tool. All practices (n=64) will receive usual care, consisting of guideline dissemination, baseline performance feedback, and continuing education. Outcomes will be assessed based on patient level data from baseline and follow-up chart reviews of adult patients (N-20,000) eligible for cholesterol measurement. Appropriate methods will be used to analyze these correlated data. Impact evaluation will be conducted via baseline and follow-up surveys of participating physicians and staff. Process evaluation will be conducted by tracking use of the PDA-based tool. We estimate as many as 48,000 major CHD events could be averted annually in the US with sufficiently improved adherence to ATPIII. If this intervention is successful, electronic decision support tools could be used to facilitate implementation of other complex CPGs. Hence, this innovative strategy holds great promise for making a substantial public health impact through the prevention of CVD and through subsequent translation to other important conditions.