A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 4
- 主要终点
- Medication adherence
研究概览
简要总结
This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.
The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.
详细描述
The strategy takes advantage of health information technology to assist patients with Medication Therapy Management (MTM) tasks, intervening with a set of low-literacy MTM printed tools triggered by the Electronic Health Record (EHR) in a primary health care clinic. Patients at the University of Illinois at Chicago (UIC) Medicine Clinic who are randomized to the intervention arm will be given three printed tools, one when they check in to the clinic and the other two when they check out. The Electronic Health Record (EHR) triggers the printing of these tools, and the receptionist hands them to the patient. Patients receive either English or Spanish language materials depending on the preference determined in the screening process and stored in their EHR.
Specific Aims
- Refine and Field Test an EHR strategy for generating and distributing low literacy prescription information for English and Spanish-speaking patients
- Assess the process of the EHR intervention and its fidelity for providing prescription information for patients at the point of prescribing and dispensing medications.
- Evaluate the effectiveness of the EHR strategy to improve medication understanding, reconciliation, regimen consolidation, and adherence compared to standard care.
In addition, we will be powered to also investigate our strategy's impact on intermediary clinical outcomes including systolic blood pressure, HbA1c, and LDL cholesterol.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-years old or older;
- •have a diagnosis of diabetes mellitus either by ICD-billing codes or indicative medications;
- •are prescribed at least (3) chronic condition medications according to the EHR medication list;
- •are English or Spanish-speaking;
- •have no imminent intention to move or change clinics within the next year;
- •score 4 or higher on the six-question screener based on the Mini-Mental Status Exam;
- •are primarily responsible for administering their own medications;
- •prescribed a new chronic condition medication (including refills, and change in titrations) during their clinic visit and day.
排除标准
- •under age of 18 years-old;
- •does not speak English or Spanish;
- •dependent on assistance for medication administration;
- •scored less than 4 on the six-question screener;
- •not prescribed a new medication or changed medication at clinical appointment;
结局指标
主要结局
Medication adherence
时间窗: One month after patients receive intervention materials
We will determine to what extent presenting low-literacy information about prescription medicines to patients with diabetes affects their adherence to a medication regimen compared to patients under standard care. Adherence for each prescription medication will be measured through multiple methodologies.
次要结局
- Clinical outcomes-systolic blood pressure, HbA1, and LDL cholesterol.(Baseline interview and after 6 months)
研究者
Bruce Lambert
Director, Center for Communication and Health
Northwestern University