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临床试验/NCT06121193
NCT06121193已完成不适用

Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年6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
已完成
入组人数
36
试验地点
1
主要终点
Patients' satisfaction of PREVENT tool: survey

研究概览

简要总结

Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 12-17 years at baseline
  • •at risk for poor CVH (body mass index >= 85th percentile)
  • •Receiving care from the Healthy Start Clinic at Barnes Jewish Hospital.

排除标准

  • 未提供

研究组 & 干预措施

Providers

No Intervention

-All eligible providers will be sent questionnaires electronically to their email at baseline, following provider training and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline.

Patients - Wait-List Control

Active Comparator

Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered at 3-months after the clinic visit electronically and by mail.

• A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.

干预措施: Wait-list Control (Behavioral)

Experimental: Patients - PREVENT Tool

Experimental

Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 3-months after the clinic visit electronically and by mail

• At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources.

干预措施: PREVENT tool (Behavioral)

结局指标

主要结局

Patients' satisfaction of PREVENT tool: survey

时间窗: 3-months

A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction.

Provider's satisfaction of PREVENT tool: survey

时间窗: 3-months

A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction.

Fidelity of PREVENT tool implementation

时间窗: 0-3 months

Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

次要结局

  • Change in food intake behaviors(At baseline, and 3-months)
  • Change in body mass index z-score(At baseline, and 3-months)
  • Change in patient's motivation(At baseline, and 3-months)
  • Change in patient's knowledge of CVH(At baseline, and 3-months)
  • Change in physical activity behaviors(At baseline, and 3-months)
  • Change on patient's average systolic and diastolic blood pressure(At baseline, and 3-months)
  • Change in patient's blood glucose(At baseline, and 3-months)
  • Change in patient's cholesterol(At baseline, and 3-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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