Incorporating PRO Data Into RA Clinical Encounters Using Health IT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 2
- 主要终点
- SURE
研究概览
简要总结
The goal of this pragmatic clinical trial is to learn if a new health IT tool that was rolled out at UCSF Health rheumatology clinics (the RA PRO dashboard) can help improve the lives of individuals with rheumatoid arthritis. The RA PRO dashboard displays important outcomes for individuals with rheumatoid arthritis, including disease activity, physical functioning, and pain scores in an easy-to-read, digital interface that can be displayed on the computer screen during a clinical visit. These outcomes are tracked over time, so patients and clinicians can see changes across multiple time points. Additional features of the dashboard include displaying medication use over time and recent lab test results.
The main questions the study aims to answer are: Does displaying the dashboard during a clinical visit ...
- reduce decisional conflict when making a medication choice?
- improve self-efficacy in symptom management?
- change beliefs about medications?
- improve medication adherence?
- improve RA outcomes such as disease activity or physical functioning?
Researchers will compare these outcomes in the patients of clinicians who have access to the RA PRO dashboard to those who do not to see if these outcomes change over time.
Clinicians with access to the dashboard may choose to share it from the computer screen with patients during the clinic visit. Participants will be asked to complete surveys as part of their routine clinic visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of rheumatoid arthritis
- •Visits with clinicians at UCSF Health clinic
- •At least 1 CDAI score documented in UCSF EHR
排除标准
- •Unable to read, speak, or understand English
- •Unable to provide informed consent
结局指标
主要结局
SURE
时间窗: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
The SURE Test (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) is a 4-item scale that measures decisional conflict in patients using a binary scale (where 0 = "no"; 1 = "yes") for a simple sum of up to 4 points. A higher score indicates greater decisional clarity.
PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a (PROMIS-SE)
时间窗: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
The PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a (PROMIS-SE) is a 4-item scale that measures self-efficacy in symptom management using a 5-point Likert-type scale (where 1 = "not at all confident"; 5 = "very confident") for a raw score range of 4 to 20, translated into T-scores with a mean of 50, and a standard deviation of 10. A higher T-score indicates greater self-efficacy.
Beliefs about Medicines Questionnaire - Specific (BMQ-Specific)
时间窗: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
The Beliefs about Medicines Questionnaire - Specific (BMQ-Specific) is comprised of two 5-item subscales that assess patients' beliefs about their need for medication to maintain health (Specific-Necessity) and their concerns about its potential negative effects (Specific-Concerns) using a Likert-type scale (1 = "strongly agree"; 5 = "strongly disagree") for a simple sum of 5 to 25 points for each subscale. Responses are used to calculate the Necessity-Concerns differential (Specific-Necessity minus Specific-Concerns) to assess patients' need for medication in comparison to their concerns. Scores range from -20 to +20, where a positive score indicates that necessity beliefs outweigh concerns.
Medication adherence
时间窗: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
Medication adherence was measured using a single item ("How many times do you think you may have missed taking your pills in the last week?"). A higher result indicates lower medication adherence.
次要结局
- CDAI score(Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.)
- PROMIS-PF10a score(Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.)