Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Understanding of prescription medication
研究概览
简要总结
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use.
详细描述
The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. Spanish-speaking patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive all their prescribed medicines from this location. Recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. We anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.
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
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type II diabetes or hypertension in their medical chart
- •Spanish speaking
- •30 years or older
排除标准
- •Uncorrectable hearing or visual impairment.
- •Too ill to participate
结局指标
主要结局
Understanding of prescription medication
时间窗: Baseline, 3 month follow-up, 9 month follow-up
Difference in understanding and comprehension of medication use as compared to control.
次要结局
- Change in HbA1c or blood pressure readings(Baseline, 3 month follow-up, 9 month follow-up)
研究者
Michael S. Wolf
Professor
Northwestern University
