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临床试验/NCT06358261
NCT06358261Enrolling By Invitation不适用

Pilot Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
2
主要终点
patient activation as assessed by the Patient Activation Measure Survey (PAM)

研究概览

简要总结

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

详细描述

Patient activation, which incorporates elements of self-efficacy and readiness to change, is particularly important in managing conditions like pre-diabetes, where the mainstay of treatment is behavioral lifestyle change and self-management. Unfortunately, Primary Care Physicians (PCPs) often do not have adequate training on how to promote patient activation. Traditionally, patient decision aids are used in shared decision-making to help elicit patient preferences and guide treatment options. However, the guides primarily focus on reviewing treatment options rather than increasing patient activation, which is key to successful and efficient behavioral counseling. The Patient Activation Measure (PAM) is a widely used and validated patient-reported outcome measure for assessing patient activation. Studies have demonstrated that using PAM to tailor care to a patient's activation level decreased health service utilization while improving clinical outcomes like blood pressure and self-management behaviors.

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a pre-diabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to pre-diabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • prediabetes
  • patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station
  • MyChart account

排除标准

  • history of diabetes
  • non-English speaker
  • severe intellectual disability or psychiatric comorbidities

研究组 & 干预措施

Intervention Arm (DPACT)

Active Comparator

In this arm, patients will have at least 2 visits with the participants primary care doctor. Before each visit, participants will complete a patient activation survey. Results of the survey will be shared with the primary care doctor and entered into the medical record so that the Diabetes Prevention Patient Activation Clinical Decision Support Tool can be used by the participants doctor during the visit to discuss lifestyle management.

干预措施: Diabetes Prevention Patient Activation Clinical Decision Support Tool (Behavioral)

Control Arm (Usual Care)

No Intervention

Patients in the control arm will follow the same visit schedule as the intervention arm. At the beginning of the study, participants will receive a handout on pre-diabetes which will include information on lifestyle changes and the benefits of joining a Diabetes Prevention Program. Before each visit, participants will complete a patient activation survey but the results will not be shared with the participants primary care doctor

结局指标

主要结局

patient activation as assessed by the Patient Activation Measure Survey (PAM)

时间窗: baseline, 6 months

measured by Patient Activation Measure (PAM) survey, a 13-item scale with 4 Likert response,s and scores ranging from 0 to 100 (higher score means higher activation level)

次要结局

  • percent of participants who make diet changes(baseline, 6 months)
  • number of participants prescribed metformin(baseline, 6 months)
  • number of participants referred to Diabetes Prevention Program(baseline, 6 months)
  • change in amount and frequency of physical activity(baseline, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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