A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency: a Stepped Wedge Cluster Randomized Control Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Percentage of subjects who have correct diagnosis of cause of low hemoglobin
研究概览
简要总结
The purpose of this study is to measure the evidence-based intervention's (EBIs) impact on patient safety and efficiency, to assess the EBIs implementation by measuring acceptability, appropriateness, cost, fidelity, penetration, and sustainability and to identify the facilitators and barriers that influence the degree of implementation of these EBIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •physicians, physicians assistants and advanced practice registered nurses in the 13 clinic locations of UTP are eligible if they care for patients at the time patient enrollment at their clinic begins
- •agree to participate.
- •Patients' inclusion criteria are:
- •hemoglobin result < 10.8 for females and < 12.5 for males with normal white cell count and platelet count (the prior hemoglobin results must have been in normal range, with a look-back period of two years)
- •an eGFR value < 60 (the prior eGFR results must have been in normal range, with a look-back range of two years)
- •the matching creatinine results must also be in normal range
- •not pregnant
- •speak English or Spanish.
排除标准
- 未提供
结局指标
主要结局
Percentage of subjects who have correct diagnosis of cause of low hemoglobin
时间窗: within 6 months from baseline
Percentage of subjects who have correct diagnosis of cause of low hemoglobin
Percentage of subjects who have correct diagnosis of cause of low glomerular filtration
时间窗: within 6 months from baseline
Percentage of subjects who have correct diagnosis of cause of low glomerular filtration
Percentage of subjects who have correct diagnosis of cause of low hemoglobin
时间窗: within 6 months from baseline
Percentage of subjects who have correct diagnosis of cause of low hemoglobin
Percentage of subjects who have correct diagnosis of cause of low glomerular filtration
时间窗: within 6 months from baseline
Percentage of subjects who have correct diagnosis of cause of low glomerular filtration
次要结局
- Cost of treatment(from baseline to 6 months)
- Sustainability as assessed by number of clinics that continued the intervention(2.5 years)
- Patient activation as assessed by the short form of the Patient Activation Measure (PAM)(between 1 to 6 months)
- Number of clinics with more facilitators than barriers(6 months)
- Time until diagnosis(initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months))
- Percentage of tests appropriately utilized(within 6 months from baseline)
- Time until diagnosis(initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months))
- Percentage of tests appropriately utilized(within 6 months from baseline)
- Cost of treatment(from baseline to 6 months)
- Number of primary care physicians (PCPs) who find the intervention as acceptable assessed by survey of PCPs(12 weeks after PCP's patient enrolled)
- Number of PCPs who find the intervention appropriate as assessed by survey of PCPs(12 weeks after PCP's patient enrolled)
- Number of PCPs who find the intervention feasible as assessed by survey of PCPs(12 weeks after PCP's patient enrolled)
- Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis(6 months)
- Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention(6 months)
- Sustainability as assessed by number of clinics that continued the intervention(2.5 years)
- Patient activation as assessed by the short form of the Patient Activation Measure (PAM)(between 1 to 6 months)
- Number of clinics with more facilitators than barriers(6 months)
研究者
Eric Thomas
Professor
The University of Texas Health Science Center, Houston