EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 767
- 试验地点
- 2
- 主要终点
- Medication Adherence: Pill Count
研究概览
简要总结
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
- Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
- Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
- Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
- Assess the costs required to deliver either intervention from a health system perspective.
详细描述
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
The investigators will conduct a 3-arm, multi-site trial to test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. The investigators will enroll a total of 900 English and Spanish-speaking patients with poorly controlled type 2 diabetes mellitus. Enrolled patients will complete follow-up interviews 3 and 6 months following their baseline interview.
The aims of the investigation are to:
- Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
- Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
- Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
- Assess the costs required to deliver either intervention from a health system perspective.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus diagnosis
- •Most recent hba1c value ≥7.5%.
- •Seek care at participating general internal medicine practices in Chicago or New York City.
- •English or Spanish speaking
- •Take 5 or more prescription drugs for chronic conditions (including 1 study medication)
排除标准
- •Severe uncorrectable vision or hearing impairment
- •Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia)
- •Not primarily responsible for administering his/her medications
- •Does not own a cell phone that can receive text messages
- •Not comfortable receiving text messages
研究组 & 干预措施
UMS Strategy + SMS Text Messaging
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
干预措施: UMS Strategy (Behavioral)
UMS Strategy + SMS Text Messaging
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
干预措施: SMS Text Messaging (Behavioral)
Usual Care
Patients of providers randomized to the usual care arm will receive their standard care
UMS Strategy
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
- Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
- Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
干预措施: UMS Strategy (Behavioral)
结局指标
主要结局
Medication Adherence: Pill Count
时间窗: 6 months after baseline
Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent.
次要结局
- Medication Adherence: 24-hour Recall(6 months after baseline)
- Medication Adherence: ASK-12(6 months after baseline)
- Treatment Knowledge(6 months after baseline)
研究者
Michael S. Wolf
Professor
Northwestern University