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为个性化 CV 预防 (SDM4IP) 实施共同决策 (SDM) (SDM4IP)

2026年7月27日 更新者：Jennifer L. Ridgeway、Mayo Clinic
心血管 (CV) 疾病是美国过早死亡和高发病率的第一大原因。尽管有临床指南，但大多数临床干预措施都是在 CV 风险相对较低的人群中实施的，而在风险最高的人群中实施的很少。 共同决策 (SDM) 可以通过减少风险盲目性和预防方案不合适来缓解风险-治疗悖论，但在常规临床护理中采用 SDM 是不完整的。 本研究涉及 SDM 在三个卫生系统中采用 CV 预防 SDM 工具。

研究概览

地位

完全的

条件

干预/治疗

详细说明

心血管 (CV) 事件的初级预防通常在风险较低的个体中更为强烈，反之亦然（所谓的“风险治疗悖论”），部分原因是没有意识到每个人的 CV 风险、他们对预防干预措施的偏好，以及它们在每个人日常生活中的可行性。 临床实践指南建议临床医生和患者共同制定一个有效且可行的预防计划，该计划符合每个人的 CV 风险和知情偏好，这一过程称为共同决策 (SDM)。 尽管有一种创新且有效的工具可以估计 CV 风险，显示可用生活方式和药物预防干预措施的影响和特征，从而可以促进临床医生和患者之间的 CV 治疗讨论，但这种类型的 SDM 在实践中并不经常发生。

因此，面临的挑战是确定在现实世界的临床实践中增加采用这种类型的 SDM 的策略。 这项为期 4 年的研究 - 由具有预防心脏病学、SDM 和实施科学专业知识的多学科团队提出 - 旨在将 SDM 工具（CV 预防选择工具）整合到美国三个不同医疗保健系统的初级保健实践中。并研究促进其采用和常规使用的工具和量身定制的策略。 该研究将使用混合方法、混合实施效果（III 型）阶梯楔形整群随机试验设计来确定：

  • 实施有效性（目标 1），通过评估实施 CV 预防选择工具的环境（包括当地工作流程和政策）以及用户参与实施战略；与这些策略相关的实施结果（例如，影响、采用）；以及实施如何促进初级保健实践中 SDM 和 CV 预防选择工具的常规采用，以及
  • SDM 有效性（目标 2）根据个人 CV 预防计划的可行性和与每个人估计的 CV 风险和偏好的一致性程度来估计。

研究人员假设，评估当地需求并使用它们来开发量身定制的实施方法的努力将促进在实践中更多地采用 SDM。 他们进一步假设，当临床医生采用 SDM 工具时，个人预防保健计划将与估计的风险一致。 广泛的目标是促进以患者为中心的护理，有效减轻美国人 CV 疾病的巨大负担。 到项目结束时，研究人员希望 (a) 确定最有效的实施策略，将 SDM 纳入常规实践，以及 (b) 估计 SDM 的有效性，以在初级保健中实现可行且风险一致的 CV 预防。

研究类型

介入性

注册 (实际的)

112127

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Georgia
      • Marietta、Georgia、美国、30060
        • Wellstar Health System
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • North Dakota
      • Grand Forks、North Dakota、美国、58201
        • Altru Health System
    • Virginia
      • Arlington、Virginia、美国、22205
        • VHC Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 临床医生参与者：将邀请所有参与初级保健实践并为有资格进行 CV 预防的成年患者提供护理的临床医生参加。
  • 患者参与者：没有经历过动脉粥样硬化血栓临床事件并在参与的初级保健实践中接受预防保健的患有或不患有糖尿病的成年患者（年龄 40-75 岁）将有资格参加。

排除标准：

- 不说英语或有任何认知缺陷会影响他们同意参与研究的能力的个人将不会被邀请参加。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
其他：Sequence 1
Sequence 1 began usual care (Step 1) on 9/24/2021, entered the active implementation period (Step 2) on 3/24/2022, and entered the maintenance period (Step 3) on 4/1/2024. In usual care, clinicans had access to CV Prevention Choice in their electronic health record but there were no other active implementation strategies deployed (passive implementation). The active implementation period included deployment of tailored implementaiton strategies. In the maintenance period, active implementation support ended but clinicians still had access to CV Prevention Choice in the EHR
行为的：CV 预防选择工具
CV Prevention Choice SDM 工具是一种共享决策干预。 它嵌入电子健康记录中，并使用 EHR 数据来估计和显示个体患者的心血管风险，然后促进临床医生和患者之间就基于个体风险和偏好的预防性护理的可用选择进行对话。
其他：Sequence 2
Sequence 2 began usual care (Step 1) on 4/13/2022, entered the active implementation period (Step 2) on 10/14/2022, and entered the maintenance period (Step 3) on 4/1/2024. In usual care, clinicans had access to CV Prevention Choice in their electronic health record but there were no other active implementation strategies deployed (passive implementation). The active implementation period included deployment of tailored implementaiton strategies. In the maintenance period, active implementation support ended but clinicians still had access to CV Prevention Choice in the EHR.
行为的：CV 预防选择工具
CV Prevention Choice SDM 工具是一种共享决策干预。 它嵌入电子健康记录中，并使用 EHR 数据来估计和显示个体患者的心血管风险，然后促进临床医生和患者之间就基于个体风险和偏好的预防性护理的可用选择进行对话。
行为的：实施促进战略
在积极实施阶段，卫生系统将部署量身定制的实施促进和其他量身定制的实施策略，旨在通过 CV Prevention Choice 增加采用和使用共享决策。
其他：Sequence 3
Sequence 3 began usual care (Step 1) on 6/13/2022, entered the active implementation period (Step 2) on 12/13/2022, and entered the maintenance period (Step 3) on 4/1/2024. In usual care, clinicans had access to CV Prevention Choice in their electronic health record but there were no other active implementation strategies deployed (passive implementation). The active implementation period included deployment of tailored implementaiton strategies. In the maintenance period, active implementation support ended but clinicians still had access to CV Prevention Choice in the EHR.
行为的：CV 预防选择工具
CV Prevention Choice SDM 工具是一种共享决策干预。 它嵌入电子健康记录中，并使用 EHR 数据来估计和显示个体患者的心血管风险，然后促进临床医生和患者之间就基于个体风险和偏好的预防性护理的可用选择进行对话。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Reach (RE-AIM): The Percentage of Clinicians Who Ever Used CV Prevention Choice
大体时间：Approximately 3.5 years
Percentage of clinicians who used CV Prevention Choice, among all eligible clinicians in participating settings. Clinicians were eligible if they had at least one encounter during the period evaluated. Utilization was recorded in the electronic health record. Higher percentages indicate greater intervention reach.
Approximately 3.5 years
Effectiveness (RE-AIM): Clinician Perceptions of CV Prevention Choice Effectiveness
大体时间：Approximately 3.5 years
Perceptions of CV Prevention Choice effectiveness, including whether it helps support shared decision making conversations, as assessed through interviews with eligible clinicians. Participant counts reflect the number of interview participants in the arm/group who indicated CV Prevention Choice supports shared decision making, does not support shared decision making, or were unsure whether it supported shared decision making.
Approximately 3.5 years
Adoption (RE-AIM): The Percentage of Clinicians Who Adopted CV Prevention Choice in Routine Care
大体时间：Approximately 3.5 years
Percentage of eligible clinicians that used CV Prevention Choice in encounters identified in the electronic health record as a visit for preventive care (visit reason listed as annual exam or annual wellness visit), among all eligible preventive care encounters. Utilization was recorded in the electronic health record. Higher percentages indicate greater adoption.
Approximately 3.5 years
Adoption (RE-AIM): Clinician Perceptions of CV Prevention Choice Adoption
大体时间：Approximately 3.5 years
Perceptions of CV Prevention Choice adoption, including reasons for adopting it or failing to adopt it in routine care, as assessed through interviews with eligible clinicians. Participant counts reflect the number of interview participants in the arm/group who gave reasons for adopting or not adopting CV Prevention Choice.
Approximately 3.5 years
Implementation (RE-AIM): Observer Scoring of Clinician Fidelity to Shared Decision Making Behaviors in Audio-video Recorded Encounters
大体时间：Approximately 1 year
A sample of clinical encounters were audio-video recorded, reviewed by trained study staff, and scored using a fidelity checklist with 10 items indicating shared decision making behaviors. Each item was scored on a on a scale from -1=Behavior was undermined by comment or action to 4=The behavior is exhibited to a very high standard. An overall average score ranging from -1 to 4 was created by averaging the 10 item scores. A higher mean score indicates greater fidelity to the core components of shared decision making.
Approximately 1 year
Implementation (RE-AIM): Average Patient-reported Rating of the Quality of Shared Decision Making After a Clinical Encounter
大体时间：Approximately 1 year
The quality of shared decision making was assessed using the Shared Decision Making Questionnaire (SDM-Q-9), which is a patient self-report measure designed to measure the extent and quality of shared decision making in a clinical encounter from the patient perspective. The nine items are scored on a 6-point Likert scale from 1 (Completely Disagree) to 6 (Completely Agree). Scores are summed and transformed to a 0-100 scale, with higher scores indicating greater perceived involvement in decision-making.
Approximately 1 year
Implementation (RE-AIM): Average Patient-reported Quality of Care After a Clinical Encounter
大体时间：Approximately 1 year
The quality of care was assessed using the 10-item Consultation and Relational Empathy (CARE) Measure, which is a patient-reported measure of the experience of care in a clinical encounter. Higher scores are indicative of higher patient reported relational empathy in the consultation. Items are scored from 1 (Poor) to 5 (Excellent) and summed for a range of scores from 10 to 50. Higher scores indicate more positive assessment of care processes.
Approximately 1 year
Maintenance (RE-AIM): The Percentage of Clinicians Using CV Prevention Choice at the End of the Maintenance Period Compared to the Beginning of the Period
大体时间：Approximately 1 year
The percentage of clinicians using CV Prevention Choice, as indicated in the electronic health record, at the transition to the maintenance period was compared to the percentage in the last two months of the maintenance phase. Equivalent or higher percentage use at the end of the maintenance stage indicates maintenance of the tool as part of routine practice.
Approximately 1 year
Maintenance (RE-AIM): Clinician Self-reported Perception of How CV Prevention Choice Differs From Usual Ways of Working
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "I can see how it differs from usual ways of working" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether CV Prevention Choice Has Potential Value for Their Work
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "I can see the potential value of it for my own work" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether There Are Key People to Drive CV Prevention Choice Forward and Get Others Involved
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "There are key people who drive it forward and get others involved" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether CV Prevention Choice Can be Easily Integrated Into Existing Work
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "I can easily integrate it into my existing work" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether Sufficient Training Was Provided to Implement CV Prevention Choice
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "Sufficient training is provided to enable staff to implement it" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years
Maintenance (RE-AIM): Clinician Self-reported Perception of Management Support for CV Prevention Choice
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "Management adequately supports it" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years
Maintenance (RE-AIM): Clinician Self-reported Perception of Whether Staff Agree CV Prevention Choice is Worthwhile
大体时间：Approximately 3 years
Seven items from the 23-item Normalization Measure Development Questionnaire (NoMAD) were administered to clinicians to assess the extent to which CV Prevention Choice had become a routine part of their practice (i.e., normalized in practice). The item "The staff agree that it is worthwhile" was scored on a Likert scale from 1=Strongly disagree to 5=Strongly agree. Higher levels of agreement indicate higher levels of normalization of CV Prevention Choice into routine care.
Approximately 3 years

次要结果测量

结果测量
措施说明
大体时间
Effectiveness: The Predicted Marginal Probability of Statin Use is Concordant With Estimated Cardiovascular Risk
大体时间：Approximately 4 years
Patient risk-concordance was assessed using all of the patient's encounter level data. Statin prescription status was captured in the EHR up to 30 days after the encounter (i.e., the patient-clinician clinical visit) and their estimated 10-year risk of developing a first atherosclerotic cardiovascular disease (ASCVD) event, calculated using the Pooled Cohort Equation and data from the EHR including: age, race, total cholesterol, HDL cholesterol, systolic blood pressure, smoking status, diabetes status, and whether the individual is receiving treatment for high blood pressure (if systolic blood pressure is greater than 120 mmHg). Risk concordance was defined as having a statin prescription in groups where ASCVD risk was > or equal to 7.5% and not having a statin prescription if it was < 7.5%. The least square means, using the patient's encounter level data, provides a marginal probability of the proportion of patients that would have a statin prescription within the risk*arm/group.
Approximately 4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mayo Clinic

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

  • 首席研究员：Jennifer Ridgeway, PhD、Mayo Clinic
  • 首席研究员：Victor Montori, MD、Mayo Clinic

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月10日

初级完成 (实际的)

2024年12月31日

研究完成 (实际的)

2025年4月29日

研究注册日期

首次提交

2020年6月22日

首先提交符合 QC 标准的

2020年6月24日

首次发布 (实际的)

2020年6月30日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月27日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20-002772
  • R01HL151662-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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