The Medication Metronome Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Medication Safety Monitoring - ACE/ARB, Thiazide
研究概览
简要总结
This project tests a model of chronic disease medication management in which the decision to initiate or adjust medical therapy is directly linked to a sequence of subsequent clinical actions (e.g. monitoring for adverse drug events, assessing response to therapy, changing medication dose) performed independently of the office visit. The investigators hypothesize that establishing a visit-independent, health information technology (IT) supported cycle of laboratory monitoring and iterative medication dose adjustment will result in more effective chronic disease care.
详细描述
To implement a new model of chronic disease management, we will build on our existing electronic health record and integrated data systems to develop an advanced health IT application called the "Medication Metronome" to enable providers to schedule future laboratory tests related to a specific set of medications (for glycemic, cholesterol, and blood pressure management). As these lab test dates become due, the Medication Metronome system will remind patients via letter and inform providers when the tests remain "missing." The goal of this intervention is to implement an efficient, visit-independent system to ensure that patients are rapidly and safely brought to evidence-based treatment goals and to prevent delays in planned laboratory monitoring. This study has the following aims:
Aim 1: To develop the Medication Metronome system. This work involves health IT development and evaluation of design prototypes to create a system that supports timely medication intensification, improves safety, and meets both patient and provider needs.
Aim 2: To conduct a randomized controlled trial of the Medication Metronome system. We will use three target chronic conditions to test different elements of the system. We hypothesize that use of the Medication Metronome system will lead to:
H2a. More effective HbA1c control among patients with type 2 diabetes prescribed hypoglycemic medicines; H2b. Safer medication management among patients with hypertension prescribed thiazide diuretics, angiotensin converting enzyme inhibitors, or angiotensin II receptor blockers; H2c. Both more effective LDL-cholesterol control and safer monitoring for hepatitis among patients with hyperlipidemia prescribed HMG-CoA reductase inhibitors.
Aim 3: To evaluate the impact of the Medication Metronome visit-independent care model on the content of office-based visits. Time spent addressing different clinical care domains will be assessed using audiotape-based content analysis in a subset of selected office visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All primary care physicians from participating practices will be eligible to participate in the study.
- •Patients Eligible for Analysis: The primary unit of analysis will be prescribed medicine, grouped with patient and within prescribing PCP. Three potentially overlapping medication-based cohorts will be defined: 1) Patients prescribed any hypoglycemic agents, 2) Patients prescribed thiazide diuretics, ACE-Is, or ARBs, and 3) Patients prescribed statins. Based on this design, individual patients may contribute to more than one medication analytic cohort.
排除标准
- •Patients Excluded from Analysis: Patients who are subsequently identified as having died during the course of the study intervention using the Social Security Death Index, to have left the MGH system, or to have changed PCPs.
结局指标
主要结局
Medication Safety Monitoring - ACE/ARB, Thiazide
时间窗: Within 4 weeks following prescription
Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring.
Primary Effectiveness Outcome - LDL
时间窗: 1 year
Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk).
Primary Effectiveness Outcome - A1c
时间窗: 1 year
Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%).
Medication Safety Monitoring - Statins
时间窗: Within 4 weeks following prescription
Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring.
Medication Safety Monitoring - Metformin
时间窗: Within 4 weeks following prescription
Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring.
次要结局
未报告次要终点
研究者
Steven Atlas
Principal Investigator
Massachusetts General Hospital