Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,764
- 试验地点
- 2
- 主要终点
- Composite rate of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, hospitalizations for chronic disease-related ambulatory care sensitive conditions
研究概览
简要总结
The purpose of this study is to determine the effect of two novel interventions; (1) a value-based formulary which eliminates copayment for selected high-value medications (proven to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient education program aimed at lifestyle modification and optimal drug use, combined with relay of information on medication use, on the risk of adverse clinical outcomes (mortality, heart attack, stroke, need for coronary revascularization, and chronic disease related hospitalizations) in low-income seniors with chronic conditions over three years of follow-up or until March 31, 2021 (whichever comes first).
详细描述
Chronic diseases, such as stroke, myocardial infarction, hypertension, diabetes and chronic kidney disease, are the major challenge facing health care systems worldwide. Although medications and lifestyle changes can improve the health of these patients, many do not benefit from these treatments due to barriers at the level of the patient, provider and/or health system, resulting in a care gap. Multiple barriers may contribute to the observed care gap for patients with these chronic diseases-but prior research has identified that 1) out-of-pocket costs for medications (including co-payments); and 2) lack of patient knowledge about the potential benefits of treatment are particularly important. Although these barriers clearly compromise outcomes among people with chronic diseases, the best way to overcome them and close the care gap is uncertain.
In the ACCESS trial, the investigators will study the effect of two novel interventions in 4764 participants with chronic disease. The investigators hypothesize that (1) eliminating copayments for high value cardioprotective medications and (2) a comprehensive patient education program on optimal medication use, combined with relay of information on optimal medication use by the patient to their health care provider, will decrease the risk of adverse clinical outcomes during the follow-up period.
Methods and study design: Parallel, open label, factorial randomized controlled trial with blinded endpoint evaluation assessing the impact of two interventions: 1) elimination of patient copayment for selected medications, and 2) patient education with relay of information to the participant's health care provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>65 years of age (have drug insurance from Alberta Blue Cross with 30% copayment)
- •Have any one of the following:
- •coronary disease
- •prior stroke
- •chronic kidney disease
- •heart failure
- •OR any two of the following:
- •current cigarette smoking (>1/2 pack per day)
- •diabetes mellitus
- •hypertension
- •hypercholesterolemia
- •Have total family income <$50,000
排除标准
- •Coverage by another insurance plan where no drug payment is required (i.e. copayment <30%)
- •Inability to participate in education modules (e.g. lack of proficiency in English; cognitive impairment).
- •Has every dose of their medication provided to them by a nurse or other professional caregiver?
- •Inability to provide informed consent
研究组 & 干预措施
Personalized Education Only
In this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions
干预措施: Personalized Education (Behavioral)
Copayment Elimination and Personalized Education
In this arm, participants would have copayment elimination (no cost for preventative medications for hypertension, diabetes, and cardiovascular disease) and free enrollment in a new personalized education program to help participants manage their chronic conditions
干预措施: Copayment Elimination (Behavioral)
Copayment Elimination and Personalized Education
In this arm, participants would have copayment elimination (no cost for preventative medications for hypertension, diabetes, and cardiovascular disease) and free enrollment in a new personalized education program to help participants manage their chronic conditions
干预措施: Personalized Education (Behavioral)
Copayment Elimination Only
In this arm, participant's would be randomized to Copayment Elimination (no cost for preventative medications for hypertension, diabetes, and cardiovascular disease) and receive some basic educational information about their chronic disease
干预措施: Copayment Elimination (Behavioral)
No intervention
In this arm, participants will have access to some basic online educational information about their chronic disease. There is no intervention in this arm. The comparative group.
结局指标
主要结局
Composite rate of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, hospitalizations for chronic disease-related ambulatory care sensitive conditions
时间窗: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
See below for definitions of individual components for this composite outcome.
次要结局
- All-cause mortality(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- Full adherence to statins(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- Non-fatal myocardial infarction(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- Non-fatal stroke(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- hospitalizations for chronic disease-related ambulatory care sensitive conditions(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- Overall health care costs(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- Need for coronary revascularization(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
- Overall quality of life as measured by the Euroqol EQ5D-5L index score(3 years or until March 31, 2021 (for patients enrolled after March 31, 2018))
研究者
Braden Manns
Svare Professor, Health Economics
University of Calgary