Incorporating PROMIS Symptom Measures Into Primary Care Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up
研究概览
简要总结
The purpose of this study is to determine the effectiveness of providing PROMIS Profile Scale scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on patients' symptoms.
详细描述
The SPADE symptoms (sleep, pain, anxiety, depression, and energy/fatigue) are the most common yet undertreated symptoms in clinical practice. Using the PROMIS (Patient-Reported Outcome Measurement Information System) Profile Scales as a measure of SPADE symptoms, this study will determine the effectiveness of providing patient symptom scores to clinicians, identify barriers and facilitators to the clinical use of such scores, and evaluate the psychometric properties of the PROMIS Profile Scales in a primary care population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •Adults ≥ 18 years of age,
- •Receiving care from a participating primary care physician
- •Report a moderate level of severity ( ≥ 4 on a 0 to 10 scale) on at least one of 5 symptoms (sleep, pain, anxiety, depression, energy/fatigue) based on a 5-item screener.
- •Primary care physicians within the Indiana University Health and Eskenazi Health systems
排除标准
- •Patients less than 18 years of age
- •Patients who do not receive care from a participating primary care physician
- •Patients who have less than a moderate level of severity (less than 4 on a 0 to 10 item scale) on each of the 5 symptoms (sleep, pain, anxiety, depression, energy/fatigue) based on a 5-item screener.
- •Physicians:
- •Primary care physicians who do not practice within the Indiana University Health or Eskenazi Health systems
结局指标
主要结局
Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up
时间窗: baseline and 3 month follow up
The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) was administered to participants at baseline and at 3 month follow up. PROMIS assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. To assess the effects of feedback on SPADE symptom improvement, group differences in the change in PROMIS composite T-scores from baseline to 3 month follow up (baseline PROMIS T-score - 3 month PROMIS T-score) were calculated. Positive change scores are indicative of symptom improvement.
次要结局
- Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up(baseline and 3 month follow up)
- Change From Baseline in PROMIS Pain T-score at 3-Month Follow up(baseline and 3 month follow up)
- Pain at 3 Month Follow up, as Measured by PEG(3 month follow up)
- Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale(3 month follow up)
- Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit(baseline)
- Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit(baseline)
- Treatment Satisfaction at 3-Month Follow-up(3 month follow-up)
- Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)(3 month follow up)
- Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit(baseline)
- Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up(baseline and 3 month follow up)
- Change From Baseline in PROMIS Depression T-score at 3-Month Follow up(baseline and 3 month follow up)
- Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up(baseline and 3 month follow up)
- Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)(3-month follow-up)
- Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)(3 month follow up)
- Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit(baseline)
研究者
Kurt Kroenke
Professor of Medicine
Indiana University