Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies (PATIENT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,752
- 试验地点
- 6
- 主要终点
- Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)
研究概览
简要总结
The purpose of this randomized clinical trial is to determine whether two low-intensity, technology based interventions, when compared to each other and to usual care, improve adherence to selected medications that are used to treat people with cardiovascular disease (CVD) and diabetes.
详细描述
The frequent failure of patients to adhere to long-term medication regimens remains the single greatest challenge for chronic-disease management. Many studies have linked medication non-adherence to treatment failure; unnecessary and dangerous intensification of therapy; and excess health care costs, hospitalizations, and deaths. Although some interventions have been shown to significantly enhance medication adherence, the strategies used are often complex, labor-intensive, and of variable effectiveness. Simple interventions designed to make small-but-significant improvements in population-based adherence may thus offer a novel, cost-effective, and easily-disseminated alternative to current approaches for enhancing adherence. The proposed PATIENT study will use health information technology (automated phone calls and access to an electronic medical record) to test two such interventions and compare them to each other and to usual care alone.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 years or older as of time of randomization.
- •Flagged in KP's databases as having either diabetes or atherosclerotic cardiovascular disease(defined as coronary artery disease, peripheral vascular disease, or a history of atherosclerotic stroke) at the time of randomization
- •At least one dispensing of an ACEI, ARB, or statin from a Kaiser Permanente (KP) outpatient pharmacy during the baseline year.
- •Suboptimal adherence ((MPR<0.9) to either statins or ACEI/ARBs during the baseline year
- •Continuous membership in KP for the 12 months prior to randomization.
- •Qualified for an intervention call at the time of randomization.
排除标准
- •Evidence in the electronic medical record (EMR) of allergy or intolerance to statins or ACE inhibitors/ARBs
- •medical conditions that would contraindicate use of statins or ACEI/ARBs
- •Absence of either a phone number or mailing address in the EMR
- •for Kaiser Permanente Hawaii, clinics whose patients tend to fill prescriptions primarily at non-KP pharmacies
- •on Kaiser Permanente's "do not contact" list or in other research studies that could add undue burden
结局指标
主要结局
Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)
时间窗: 12 months post randomization
We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.
Adherence to Statins
时间窗: 12 months post randomization
We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.
次要结局
- Percentage With Good (>80%) Statin Adherence(12 months post randomization)
- Percentage With Good (>80%) ACEI/ARB Adherence(12 months post randomization)
- Systolic Blood Pressure (SBP)(12-months post randomization)
- Percentage With Good (<140/90 mmHg) Blood Pressure Control(12 months post randomization)
- Post Intervention Low Density Lipoprotein (LDL) Level(12 months post randomization)
- Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control(12 months post randomization)