Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- Prescription Understanding
研究概览
简要总结
The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.
详细描述
Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.
We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.
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
- •age 30 or older
- •taking 3 or more prescription medications for chronic conditions
- •English or Spanish speaking
排除标准
- •self-reported severe, uncorrectable vision
- •hearing impairment
- •cognitive impairment
- •not responsible for administering his/her own medications
- •not able to receive text messages on their cell phone
研究组 & 干预措施
Usual Care
Employ the current standard of care. No intervention.
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.
- Prescription instructions will be adapted to UMS to establish four standard time intervals 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 content from a patient's perspective and following health literacy best practices.
- A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.
干预措施: UMS Strategy (Other)
UMS strategy + SMS texting reminders
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
干预措施: UMS Strategy (Other)
UMS strategy + SMS texting reminders
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
干预措施: SMS Texting Reminders (Other)
结局指标
主要结局
Prescription Understanding
时间窗: 6 months after baseline
Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.
次要结局
- Medication Adherence: PMAQ(6 months after baseline)
- Medication Adherence: Pill Count(6 months after baseline)
- Medication Knowledge(6 months after baseline)
- Medication Adherence: Pharmacy Records(6 months after baseline)
研究者
Michael S. Wolf
Professor
Northwestern University