Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial.
Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial.
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个性化疾病预防（PDP）：集群随机临床试验的研究方案。
作者：
美国预防服务工作组建议为中年人提供25项初级预防服务，但很难做到所有这些。个性化疾病预防（PDP）群集随机临床试验将评估患者及其提供者是否受益于循证决策工具，以根据其改善质量调整预期寿命的潜力优先考虑预防服务。决策工具将针对患者风险因素进行个性化，并可在电子健康记录中使用。这项III期试验旨在招募60名初级保健提供者（集群）和600名40-75岁的患者。一半的提供者将被分配到一个干预，利用决策工具，每个约10名患者，一半将被分配到常规护理。混合方法的后续行动将包括收集预防保健利用电子健康记录，病人和医生的调查，定性访谈。我们假设，与对照组相比，接受干预的患者的质量调整预期寿命将增加更多。PDP将测试一种新颖的整体方法，以帮助患者和提供者根据电子健康记录中的患者风险因素优先提供预防服务。ClinicalTrials.gov NCT 05463887。于2022年7月19日注册。在线版本包含补充材料，可通过10.1186/s13063-022-06750-7获得。
The US Preventive Services Task Force recommends 25 primary preventive services for middle-aged adults, but it can be difficult to do them all. The Personalized Disease Prevention (PDP) cluster-randomized clinical trial will evaluate whether patients and their providers benefit from an evidence-based decision tool to prioritize preventive services based on their potential to improve quality-adjusted life expectancy. The decision tool will be individualized for patient risk factors and available in the electronic health record. This Phase III trial seeks to enroll 60 primary care providers (clusters) and 600 patients aged 40–75 years. Half of providers will be assigned to an intervention to utilize the decision tool with approximately 10 patients each, and half will be assigned to usual care. Mixed-methods follow-up will include collection of preventive care utilization from electronic health records, patient and physician surveys, and qualitative interviews. We hypothesize that quality-adjusted life expectancy will increase by more in patients who receive the intervention, as compared with controls. PDP will test a novel, holistic approach to help patients and providers prioritize the delivery of preventive services, based on patient risk factors in the electronic health record. ClinicalTrials.gov NCT05463887. Registered on July 19, 2022. The online version contains supplementary material available at 10.1186/s13063-022-06750-7.
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