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个性化疾病预防(PDP):一项整群随机临床试验的研究方案。

Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial.

机构信息

Cleveland Clinic Community Care, Cleveland Clinic, 9500 Euclid Ave., G10, Cleveland, OH, USA.

Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.

出版信息

Trials. 2022 Oct 22;23(1):892. doi: 10.1186/s13063-022-06750-7.

Abstract

BACKGROUND

The US Preventive Services Task Force recommends 25 primary preventive services for middle-aged adults, but it can be difficult to do them all.

METHODS

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.

DISCUSSION

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05463887. Registered on July 19, 2022.

摘要

背景

美国预防服务工作组建议为中年成年人提供 25 种主要预防服务,但要做到这一点可能很困难。

方法

个性化疾病预防(PDP)整群随机临床试验将评估患者及其提供者是否受益于基于潜在改善质量调整预期寿命的证据决策工具来优先考虑预防服务。决策工具将根据患者的风险因素进行个性化定制,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(群集)和 600 名 40-75 岁的患者。一半的提供者将被分配到干预组,以使用决策工具为大约 10 名患者提供服务,另一半将被分配到常规护理组。混合方法的后续行动将包括从电子健康记录中收集预防保健的使用情况、患者和医生的调查以及定性访谈。我们假设接受干预的患者的质量调整预期寿命将比对照组增加更多。

讨论

PDP 将测试一种新颖的、全面的方法,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。

试验注册

ClinicalTrials.gov NCT05463887。注册于 2022 年 7 月 19 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a71d/9587586/66eafd0bdbc7/13063_2022_6750_Fig1_HTML.jpg

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